A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
122-599: Medtronic plc is an American-Irish medical device company. The company's operational and executive headquarters are in Minneapolis, Minnesota , and its legal headquarters are in Ireland due to its acquisition of Irish-based Covidien in 2015. While it primarily operates in the United States, it operates in more than 150 countries and employs over 90,000 people. It develops and manufactures healthcare technologies and therapies. It
244-720: A medical practitioner 's supervision like ibuprofen . In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program , but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016. During
366-460: A "FDA Compliant" or "FDA Acceptable". Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by
488-533: A 2015 interview to the Financial Times saying, "We just followed the rules and the deal was done based on strategic merits". Ireland is less than 0.1% of Medtronic (or Covidien) sales, and the majority of Medtronic's sales, and an even greater percentage of Medtronic profits (due to the higher margins on U.S. medical devices), are from the U.S. healthcare system. In 2016, the Star Tribune reported that Medtronic
610-787: A CA. In Italy it is the Ministero Salute (Ministry of Health) Medical devices must not be mistaken with medicinal products . In the EU, all medical devices must be identified with the CE mark . The conformity of a medium or high risk medical device with relevant regulations is also assessed by an external entity, the Notified Body , before it can be placed on the market. In September 2012, the European Commission proposed new legislation aimed at enhancing safety, traceability, and transparency. The regulation
732-410: A European Council Resolution of May 1985, represents an innovative way of technical harmonisation. It aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators, to facilitate free movement of goods inside the EU. The previous core legal framework consisted of three directives: They aim at ensuring a high level of protection of human health and safety and
854-425: A REMS program called iPLEDGE . Generic drugs are chemical and therapeutic equivalents of name-brand drugs, normally whose patents have expired. Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in
976-689: A case. The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America. As of 2021, the FDA had responsibility for overseeing $ 2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example, pharmaceutical firms pay fees to expedite drug reviews. According to Forbes, pharmaceutical firms provide 75% of
1098-513: A company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether
1220-426: A complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh . When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within
1342-406: A conformity test carried out by a European Notified Body. Class IIb Devices: Slightly more complex than IIa devices, class IIb devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Examples include ventilators and intensive care monitoring equipment. Identical compliance route to Class IIa devices with an added requirement of
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#17330861296091464-411: A device type examination by a Notified Body. Class III Devices: Class III devices are strictly high risk devices. Examples include balloon catheters, prosthetic heart valves, pacemakers, etc. The steps to approval here include a full quality assurance system audit, along with examination of both the device's design and the device itself by a European Notified Body. The authorization of medical devices
1586-539: A doctor of heart surgery at the University of Minnesota Medical School . The deficiencies of the artificial pacemakers of the day were made painfully obvious following a power outage over Halloween in 1957, which affected large sections of Minnesota and western Wisconsin . A pacemaker-dependent paediatric patient of Lillehei died because of the blackout. The next day, Lillehei spoke with Bakken about developing some form of battery -powered pacemaker. Bakken modified
1708-670: A feasibility study that found that banning the use of live animals was impractical. As of 2015 Medtronic continued to use live animals for testing and training but stated that it would look for alternatives in the future. In each case, PETA withdrew its shareholder resolution after talks with Medtronic's leadership. In June 2014, Medtronic announced it would execute a tax inversion to Ireland by acquiring Irish-based Covidien (a previous U.S. tax inversion to Ireland in 2007), for $ 42.9 billion in cash and stock. The tax inversion enabled Medtronic to move its legal headquarters to Ireland, while maintaining its operational and executive headquarters in
1830-635: A function) can be marketed purely by self-certification. The European classification depends on rules that involve the medical device's duration of body contact, invasive character, use of an energy source, effect on the central circulation or nervous system, diagnostic impact, or incorporation of a medicinal product. Certified medical devices should have the CE mark on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, do not reuse, etc. In November 2018,
1952-689: A greater potential risk and are subject to in-depth scrutiny. A guidance document for device classification is published by Health Canada. Canadian classes of medical devices correspond to the European Council Directive 93/42/EEC (MDD) devices: Examples include surgical instruments (Class I), contact lenses and ultrasound scanners (Class II), orthopedic implants and hemodialysis machines (Class III), and cardiac pacemakers (Class IV). Medical devices in India are regulated by Central Drugs Standard Control Organisation ( CDSCO ). Medical devices under
2074-425: A human being; the restoration, correction or modification of a body function or the body structure of a human being; the diagnosis of pregnancy in a human being; or the care of a human being during pregnancy and at and after the birth of a child, including the care of the child. It also includes a contraceptive device but does not include a drug." The term covers a wide range of health or medical instruments used in
2196-510: A larger share, Japan has the second largest country market share. The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom. The rest of the world comprises regions like (in no particular order) Australia, Canada, China, India, and Iran. This article discusses what constitutes a medical device in these different regions and throughout
2318-432: A long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if
2440-733: A manufacturer and seller of spinal implants that are necessary for procedures like kyphoplasty . In May 2008, Medtronic Spine agreed to pay the US government $ 75 million to settle a qui tam lawsuit after a whistleblower alleged that Medtronic committed Medicare fraud. The company was charged with illegally convincing healthcare providers to offer kyphoplasty, a spinal fracture repair surgery, as an inpatient, not an outpatient, procedure to make thousands of dollars more in profits per surgery. A "special report" by writer Steven Brill in Time showed that according to Medtronic's quarterly SEC filing of October 2012,
2562-587: A manufacturing facility in France. In February 2016, the company announced that it would acquire Bellco from private equity firm Charme Capital Partners. In June, the company announced its acquisition of HeartWare International Inc. for $ 1.1 billion. In December 2017, Medtronic acquired Crospon in €38 million ($ 45 million). In September 2018, the company acquired Mazor Robotics for $ 1.64 billion ($ 58.50 per American Depository Share or $ 29.25 per ordinary share. In late November, Medtronic acquired Nutrino Health Ltd boosting
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#17330861296092684-555: A new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations. The Office of Regulatory Affairs is considered the agency's "eyes and ears", conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, inspect production, warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in
2806-647: A number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices. The Office of Criminal Investigations was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of
2928-1071: A potential, unreasonable risk of illness or injury and require premarket approval . Examples of Class III devices include implantable pacemakers, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants. The classification of medical devices in the European Union is outlined in Article IX of the Council Directive 93/42/EEC and Annex VIII of the EU medical device regulation . There are basically four classes, ranging from low risk to high risk, Classes I, IIa, IIb, and III (this excludes in vitro diagnostics including software, which fall in four classes: from A (lowest risk) to D (highest risk)): Class I Devices: Non-invasive, everyday devices or equipment. Class I devices are generally low risk and can include bandages, compression hosiery, or walking aids. Such devices require only for
3050-568: A production site for implantable pacemakers and brain pacemakers in Tolochenaz , Switzerland. One in five pacemakers implanted globally today is made here. The site is also used as a European training centre for doctors. In 1998, Medtronic acquired Physio-Control for $ 538 million. In 2014, Integra LifeSciences announced it was acquiring instrumentation lines from Medtronic for $ 60 million. The deal included Medtronic's MicroFrance and Xomed manual ENT and laparoscopic surgical instruments, as well as
3172-494: A role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis. However, on December 29, 2022, President Biden signed
3294-523: A satisfied requirement. The FDA does not approve applied coatings used in the food processing industry . There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like Polytetrafluoroethylene (Teflon) are not and cannot be considered as FDA Approved, but rather, they are
3416-605: A separate interface. Medtronic is a corporate partner of Human Rights Campaign , a large LGBT advocacy organization. In 2005, 2008, and 2010 PETA threatened to submit a shareholder resolution to improve animal welfare standards in the company. In 2005, PETA attempted to stop five specific animal experiments that it deemed "crude and cruel". In 2008, PETA protested the outsourcing of animal testing to countries with lax animal welfare laws, such as China . In 2010, PETA attempted to stop Medtronic's reported use of live animals in testing and training. In response, Medtronic conducted
3538-476: A small pacemaker that could be strapped to the body and powered by batteries. Work in the new field later produced an implantable pacemaker in 1960. The company built its headquarters in the Minneapolis suburb of St. Anthony, Minnesota , in 1960, and moved to Fridley in the 1970s. Medtronic's main competitors in the cardiac rhythm field include Boston Scientific and St. Jude Medical . In 1997, Medtronic opened
3660-426: A strategic partnership with CathWorks, a coronary artery disease (CAD) technology developer. A separate agreement gave Medtronic the option to acquire CathWorks in the future. In October 2022, the company announced its intention to pursue a separation of the company's combined Patient Monitoring and Respiratory Interventions businesses, which are part of the company's Medical Surgical Portfolio. In May 2018, Medtronic
3782-440: A substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.) The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and
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3904-540: A surgical navigation division to design "StealthStation" systems, software, and instruments for computer assisted surgery (CAS) and a special intraoperative X-ray imaging system (3D fluoroscopy), known as the O-arm Imaging System. Many of the products are used for minimally-invasive surgical procedures. In 2016, the business unit was dissolved, and each site folded into new business groups. The Renal Care Solutions business group designed and manufactured products for
4026-553: A warning to that effect. According to the industry advocacy group, the American Council on Science and Health , though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play
4148-401: Is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by
4270-651: Is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed". Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of ZMapp and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in
4392-451: Is an AI-powered video management and analytics platform for the operating room. In May, Medtronic and DaVita Inc. announced plans to form a new, independent kidney care-focused medical device company. Medtronic's Renal Care Solutions business will be part of the new company. In April 2022, the company announced that it would work with GE Healthcare to support the needs and care demands at Ambulatory Surgery Centers. In July, Medtronic announced
4514-524: Is based on the perimeter of the California State University, Northridge campus in Northridge, California . The original company, Minimed Technologies, was founded in 1983 by Alfred E. Mann and spun off from Pacesetter Systems to design and market an open loop insulin pump . The MiniMed 502 was one of the first lightweight insulin pumps on the market, and it helped bring insulin pump usage to
4636-699: Is collectively known as the Medical Device Directive (MDD). On May 26, 2017, the Medical Device Regulation (MDR) replaced the MDD. Medical devices vary in both their intended use and indications for use. Examples range from simple, low-risk devices such as tongue depressors , medical thermometers , disposable gloves , and bedpans to complex, high-risk devices that are implanted and sustain life. One example of high-risk devices are those with embedded software such as pacemakers , and which assist in
4758-547: Is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers , cellular phones , and condoms . In addition, the FDA takes control of diseases in
4880-493: Is essential for maintaining patient and staff safety while simultaneously facilitating the marketing of medical products. By establishing different risk classifications, lower risk devices, for example, a stethoscope or tongue depressor, are not required to undergo the same level of testing that higher risk devices such as artificial pacemakers undergo. Establishing a hierarchy of risk classification allows regulatory bodies to provide flexibility when reviewing medical devices. Under
5002-600: Is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, Ir, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body . A Notified Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not require sterilization or do not measure
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5124-656: Is located in the White Oak area of Silver Spring, Maryland . The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Virgin Islands , and Puerto Rico . In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. FDA headquarters facilities are currently located in Montgomery County and Prince George's County , Maryland. Since 1990,
5246-518: Is now a European subsidiary of the unit. Medtronic and Vitatron pacemakers are interrogated and programmed by Medtronic Carelink Model 2090 Programmer for Medtronic and Vitatron Devices; they use separate interfaces. In 2007, Medtronic recalled its Sprint Fidelis product, the flexible wires, or leads, which connect a defibrillator to the interior of the heart. The leads were found to be failing at an unacceptable rate, resulting in unnecessary shocks or no shocks when needed; either can be lethal. The scope of
5368-454: Is one of the biggest medical tech companies in the world and is currently the largest medical device company in the world by revenue. Medtronic was founded in 1949 in Minneapolis by Earl Bakken and his brother-in-law, Palmer Hermundslie, as a medical equipment repair shop. Bakken invented several medical technology devices that continue to be used around the world today. Through his repair business, Bakken came to know C. Walton Lillehei ,
5490-782: Is risk-based and defines four levels: A - Low Risk, B - Low to Moderate Risk, C - Moderate – High Risk, and D - High Risk. The classification of medical devices in Australia is outlined in section 41BD of the Therapeutic Goods Act 1989 and Regulation 3.2 of the Therapeutic Goods Regulations 2002, under control of the Therapeutic Goods Administration . Similarly to the EU classification, they rank in several categories, by order of increasing risk and associated required level of control. Various rules identify
5612-449: Is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar to that for drugs. The original authority for government regulation of biological products
5734-737: Is the branch of the FDA responsible for the premarket approval of all medical devices , as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&;C Act, and it includes products from the simple toothbrush to complex devices such as implantable neurostimulators . CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation . Examples of CDRH-regulated devices include cellular phones , airport baggage screening equipment , television receivers , microwave ovens , tanning booths , and laser products . CDRH regulatory powers include
5856-696: Is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to new molecular entities : drugs that are not based on existing medications. New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Presidency of Donald Trump , the agency has worked to make the drug-approval process go faster. Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status
5978-451: Is voluntary. While this remains the primary tool of post-market safety surveillance , FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials , called Phase IV trials. In some cases, the FDA requires risk management plans called Risk Evaluation and Mitigation Strategies (REMS) for some drugs that require actions to be taken to ensure that
6100-623: The Wall Street Journal listed Medtronic's 2015 tax inversion to Ireland as the largest U.S. corporate tax inversion executed between 2013 and 2016. In May 2018, Medtronic was ranked as the largest corporate tax inversion in history. In November 2021, the company was added to the Dow Jones Sustainability World Index . Medtronic has four main business units: the Minimally Invasive Therapies Group,
6222-671: The Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) and offices for the Center for Veterinary Medicine (CVM). With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately 1,600,000 square feet (150,000 square metres) of office and special use space to their existing facilities. The National Capital Planning Commission approved
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#17330861296096344-475: The Federal Administrative Court of Switzerland decided that the "Sympto" app, used to analyze a woman's menstrual cycle, was a medical device because it calculates a fertility window for each woman using personal data. The manufacturer, Sympto-Therm Foundation, argued that this was a didactic, not a medical process. the court laid down that an app is a medical device if it is to be used for any of
6466-487: The Federal Food Drug & Cosmetic (FD&C) Act defines a device as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for
6588-1257: The Food, Drug, and Cosmetic Act , the U.S. Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. The classification procedures are described in the Code of Federal Regulations , Title 21, part 860 (usually known as 21 CFR 860). Class I devices are subject to the least regulatory control and are not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments. Class II devices are subject to special labeling requirements, mandatory performance standards and postmarket surveillance . Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, surgical drapes, stereotaxic navigation systems, and surgical robots. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present
6710-639: The coronavirus pandemic , FDA granted emergency use authorization for personal protective equipment (PPE), in vitro diagnostic equipment, ventilators and other medical devices. On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the USDA's Food Safety and Inspection Service (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died. The Center for Biologics Evaluation and Research
6832-606: The '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', which is a stricter regulation that is different from the previous regulations. MoCRA requires compliance with matters such as serious adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). MoCRA also calls on the FDA to grant Mandatory Recall Authority and establish regulations for GMP rules, flavor allergen labeling rules, and testing methods for cosmetics containing talc. The Center for Veterinary Medicine (CVM)
6954-580: The 150,000-square-foot (14,000 m) facility. In September 2016, the FDA approved a device, the MiniMed 670G which was launched in 2017. It was the world's first Hybrid Closed Loop system for people with type 1 diabetes. Featuring the company's advanced algorithm - SmartGuard technology and glucose sensor - Guardian™ Sensor 3, it was the first insulin pump approved by the Food and Drug Administration (FDA) that enabled personalized and automated* delivery of basal insulin,
7076-406: The 1990s, accounted for about a third of all prescriptions written in the United States. For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an Abbreviated New Drug Application (ANDA). 80% of prescription drugs sold in
7198-688: The Diabetes Group, the Restorative Therapies Group, and the Cardiac and Vascular Group. Medtronic develops and manufactures devices and therapies to treat more than 30 chronic diseases, including heart failure , Parkinson disease , urinary incontinence , Down syndrome , obesity , chronic pain , spinal disorders and diabetes . Cardiac rhythm disease management (CRDM) is the oldest and largest of Medtronic's business units. Its work in heart rhythm therapies dates back to 1957 when Bakken developed
7320-841: The Drugs & Cosmetics Act. Section 3 (b) (iv) relating to definition of "drugs" holds that "Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals" are also drugs. As of April 2022, 14 classes of devices are classified as drugs. The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these combination products takes this factor into consideration. Classifying medical devices based on their risk
7442-510: The Drugs and Cosmetics runs under 1945. CDSCO classification for medical devices has a set of risk classifications for numerous products planned for notification and guidelines as medical devices. Food and Drug Administration The United States Food and Drug Administration ( FDA or US FDA ) is a federal agency of the Department of Health and Human Services . The FDA is responsible for protecting and promoting public health through
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#17330861296097564-501: The FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently work closely with the Federal Bureau of Investigation , Assistant Attorney General , and even Interpol . OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of
7686-622: The FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating
7808-687: The FDA has had employees and facilities on 130 acres (53 hectares) of the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland . In 2001, the General Services Administration (GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the Washington metropolitan area , its headquarters in Rockville , and several fragmented office buildings. The first building,
7930-703: The FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable. The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018,
8052-581: The FDA's drug review budget Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic. The programs for safety regulation vary widely by the type of product, its potential risks, and
8174-871: The Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling of both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods, food additives , added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements . Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids , and enzymes . Specific standards
8296-623: The Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately 3,800,000 square feet (350,000 square metres) of space, divided into ten offices and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA),
8418-610: The Medical Devices Rules, 2017 are classified as per Global Harmonization Task Force (GHTF) based on associated risks. The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and
8540-469: The U.S., thus allowing it to avoid taxation on more than $ 14 billion held overseas, and avail of Ireland's beneficial low corporation tax regime . Medtronic's tax inversion is the largest tax inversion in history, and given the changes in the U.S. tax-code in 2016 to block the Pfizer-Allergan Irish tax inversion, is likely to remain the largest. Medtronic CEO Omar Ishrak defended the tax inversion in
8662-477: The United States are generic brands. In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from
8784-509: The achievement of its primary intended purposes. The term 'device' does not include software functions excluded pursuant to section 520(o)." According to Article 1 of Council Directive 93/42/EEC, 'medical device' means any "instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by
8906-757: The agency published an online "black list", in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from generic drug companies. The FDA frequently works with other federal agencies, including the Department of Agriculture , the Drug Enforcement Administration , Customs and Border Protection , and the Consumer Product Safety Commission . They also often work with local and state government agencies in performing regulatory inspections and enforcement actions. The regulation of food and dietary supplements by
9028-409: The article these regions will be discussed in order of their global market share. A global definition for medical device is difficult to establish because there are numerous regulatory bodies worldwide overseeing the marketing of medical devices. Although these bodies often collaborate and discuss the definition in general, there are subtle differences in wording that prevent a global harmonization of
9150-468: The authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing. Clearance requests are required for medical devices that prove they are "substantially equivalent" to
9272-504: The background insulin needed to maintain stable blood sugar levels throughout the day and night. The advanced SmartGuard Auto Mode algorithm worked in conjunction with the company's glucose sensor - Guardian Sensor 3 - to self-adjust basal insulin delivery based on the glucose sensor. The surgical technologies business group designed and manufactured products for the diagnosis and treatment of ear, nose, and throat (ENT) diseases and cranial, spinal, and neurologic conditions. It also encompassed
9394-473: The case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. The districts are based roughly on the geographic divisions of the Federal court system . Each district comprises a main district office and
9516-432: The company announced it would acquire Medicrea for €7.00 per share. In August, Medtronic announced it would acquire Companion Medical, who manufacture a smart insulin pen system, which connects to a diabetes management app. In September Medtronic acquired Avenu Medical for an undisclosed sum. In February 2021, the company recalled its HeartWare Ventricular Assist Device. In June 2021, the controller ports were pulled from
9638-774: The company had, on average, a 75.1% profit margin on its spine products and therapies. Medtronic's cardiovascular therapies span the major specialties of interventional cardiology, cardiac surgery, and vascular surgery. The products are used to reduce the potentially debilitating effects of coronary, aortic, and structural heart disease. Neuromodulation is the second-oldest and third-largest department of Medtronic. Its products include neurostimulation systems and implantable drug delivery systems for chronic pain, common movement disorders, and urologic and gastrointestinal disorders. The department's revenues in 2014 amounted to $ 1.9 billion, or 11% of Medtronic's total revenues. The diabetes management manufacturing and sales division of Medtronic
9760-604: The company's nutrition-related data services and analytics. In May 2019, Medtronic announced it would acquire Titan Spine, a technology company focusing on titanium spine implants. Chief Executive Officer Omar Ishrak retired in April 2020 and stayed on as executive chairman and chairman of the board until December 2020. Ishrak was succeeded by senior executive Geoff Martha. In January 2020, the company announced its intention to acquire Stimgenics, LLC and their primary therapy: differential target, multiplexed, spinal cord stimulation. In July,
9882-418: The conduct of medical testing , implants , and prostheses . The design of medical devices constitutes a major segment of the field of biomedical engineering . The global medical device market was estimated to be between $ 220 and US$ 250 billion in 2013. The United States controls ≈40% of the global market followed by Europe (25%), Japan (15%), and the rest of the world (20%). Although collectively Europe has
10004-502: The contexts varying from household pets to human sperm donated for use in assisted reproduction . The FDA is led by the commissioner of Food and Drugs , appointed by the President with the advice and consent of the Senate . The commissioner reports to the secretary of health and human services . Robert Califf is the current commissioner as of February 17, 2022. The FDA's headquarters
10126-404: The control and supervision of food safety , tobacco products, caffeine products, dietary supplements , prescription and over-the-counter pharmaceutical drugs (medications), vaccines , biopharmaceuticals , blood transfusions , medical devices , electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products . The FDA's primary focus
10248-445: The definition of a medical device, thus the appropriate definition of a medical device depends on the region. Often a portion of the definition of a medical device is intended to differentiate between medical devices and drugs , as the regulatory requirements of the two are different. Definitions also often recognize In vitro diagnostics as a subclass of medical devices and establish accessories as medical devices . Section 201(h) of
10370-452: The design for a transistorized metronome and created the first battery-powered external pacemaker. It fit in a four-inch-square box that could be taped to a patient's chest, transmitted electric signals to the heart through wires that passed through the patient's chest, and could be removed without surgery. The company expanded through the 1950s, selling equipment built by other companies but also developing custom-made devices. Bakken built
10492-420: The device's category The Medical Devices Bureau of Health Canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer's declaration of device safety and effectiveness, whereas Class III and IV devices present
10614-490: The diagnosis and treatment related to Renal organs like Kidney. In 2023 this business unit was spun off into an independent business called Mozarc Medical. In 2011, an independent security researcher, Jay Radcliffe, revealed a security vulnerability in a Medtronic insulin pump at the Computer Security conference Black Hat Briefings , allowing an attacker to take control of the pump. Medtronic responded by assuring users of
10736-466: The drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs. The term off-label refers to the practice of prescribing a drug for a different purpose than what the FDA approved. Due to this approval requirement, manufacturers were prohibited from advertising COVID-19 vaccines during
10858-416: The drug is used safely. For example, thalidomide can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many opioid drugs have REMS programs to avoid addiction and diversion of drugs. The drug isotretinoin has
10980-678: The early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York. Over-the-counter (OTC) are drugs like aspirin that do not require a doctor's prescription. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without
11102-648: The federal agency resulted in racketeering and in violations of antitrust law . "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies ( Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes. Furthermore, it
11224-436: The federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs. The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients,
11346-418: The first wearable heart pacemaker to treat abnormally slow heart rates. Since then, it has expanded its expertise in electrical stimulation to treat other cardiac rhythm diseases. It has also made an effort to address overall disease management by adding diagnostic and monitoring capabilities to many of its devices. An independently-operating Dutch pacemaker manufacturer, Vitatron , acquired by Medtronic in 1986,
11468-581: The full safety of its devices. In 2008, a team of computer security researchers was able to take remote control of a Medtronic cardiac implant. The team, using an unused implant in a lab, was able to control the electrical shocks delivered by the defibrillator component and even glean patient data from the device. In February 2020, Medtronic recalled around 322,000 MiniMed insulin pumps with faulty pump retainer rings, which had been correlated to death and around 2,000 injuries. On 30 March 2020, Medtronic shared its portable ventilator design specifications during
11590-472: The good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47 EC. The government of each Member State must appoint a competent authority responsible for medical devices. The competent authority (CA) is a body with authority to act on behalf of
11712-545: The issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission . The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines . The drug advertising regulation contains two broad requirements: (1)
11834-484: The mainstream market. In 1992, the MiniMed 506 was a major redesign to make it more appealing to consumers. The new design was met by boosted adoption rate, and sales increased by 357%. In 2001, Medtronic purchased Minimed, to form Medtronic Minimed. On 11 May 2009, Medtronic announced it had chosen San Antonio, Texas , for the location of its new Diabetes Therapy Management and Education Center. The company announced that it expected 1400 new jobs would be created to staff
11956-524: The manufacturer must provide a technical file and be certified by a European Notified Body for manufacturing in accordance with metrology regulations. Class IIa Devices: Class IIa devices generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term. Class IIa devices are those which are installed within the body for only between 60 minutes and 30 days. Examples include hearing-aids, blood transfusion tubes, and catheters. Requirements include technical files and
12078-480: The manufacturer to be used for human beings for the purpose of: and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;" Based on the New Approach , rules that relate to safety and performance of medical devices were harmonised in the EU in the 1990s. The New Approach , defined in
12200-678: The manufacturer to complete a Technical File. Class Is Devices: Class Is devices are similarly non-invasive devices, however this sub-group extends to include sterile devices. Examples of Class Is devices include stethoscopes, examination gloves, colostomy bags, or oxygen masks. These devices also require a technical file, with the added requirement of an application to a European Notified Body for certification of manufacturing in conjunction with sterility standards. Class Im Devices: This refers chiefly to similarly low-risk measuring devices. Included in this category are: thermometers, droppers, and non-invasive blood pressure measuring devices. Once again
12322-572: The market. On 3 June 2021, the FDA alerted physicians to stop new implants of the HVAD system due to "an increased risk of neurological adverse events and mortality associated with the internal pump." In January 2022, the business announced it would acquire Affera, Inc. In March, Medtronic announced a contract with Vizient, a healthcare performance improvement company, to add Medtronic's Touch Surgery Enterprise platform to Vizient's healthcare offerings. Touch Surgery works with laparoscopic and robotic scopes and
12444-571: The medical purposes provided by law, and creates or modifies health information by calculations or comparison, providing information about an individual patient. Medical devices (excluding in vitro diagnostics) in Japan are classified into four classes based on risk: Classes I and II distinguish between extremely low and low risk devices. Classes III and IV, moderate and high risk respectively, are highly and specially controlled medical devices. In vitro diagnostics have three risk classifications. For
12566-539: The member state to ensure that member state government transposes requirements of medical device directives into national law and applies them. The CA reports to the minister of health in the member state. The CA in one Member State has no jurisdiction in any other member state, but exchanges information and tries to reach common positions. In the UK, for example, the Medicines and Healthcare products Regulatory Agency (MHRA) acted as
12688-469: The outbreak of COVID-19 pandemic , in order to accelerate global ventilator production. Vitatron is a Netherlands -based European subsidiary of Medtronic. It is focused on development and manufacturing of cardiac pacing technology . Once an independently operating Dutch medical company, it was acquired by Medtronic in 1986. Vitatron pacemakers are interrogated and programmed by Medtronic Carelink Model 2090 Programmer for Medtronic and Vitatron Devices, using
12810-533: The period in which they had only been approved under Emergency Use Authorization . After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals
12932-422: The predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed. Cosmetics are regulated by the Center for Food Safety and Applied Nutrition ,
13054-431: The problem continues to be a matter of research. Studies since the recall, disputed by Medtronic, suggest that the failure rate of already-implanted Sprint Fidelis leads is increasing exponentially. Medtronic's liability is limited by various court decisions. Spinal and biologics is Medtronic's second-largest business. Medtronic is the world leader in spinal and musculoskeletal therapies. In 2007, Medtronic purchased Kyphon,
13176-566: The regulated industries. Rather, OCI agents pursue and develop cases when individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of Title 18 of the United States Code (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of
13298-470: The regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483 . In June 2018,
13420-476: The remaining regions in the world, the risk classifications are generally similar to the United States, European Union, and Japan or are a variant combining two or more of the three countries' risk classifications. The ASEAN Medical Device Directive (AMDD) has been adopted by several southeast Asian countries. The nations are at varying stages of adopting and implementing the Directive. The AMDD classification
13542-448: The safety and labeling of their product. The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having
13664-458: The same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see Cosmeceutical ). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear
13786-406: The structure or functions of the body of man or other animals." The term medical device, as defined in the Food and Drugs Act , is "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in
13908-484: The time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated. Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in 1993 by what
14030-561: The treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Health Canada reviews medical devices to assess their safety, effectiveness, and quality before authorizing their sale in Canada. According to the Act, medical device does not include any device that is intended for use in relation to animals. India has introduced National Medical Device Policy 2023. However, certain medical devices are notified as DRUGS under
14152-549: The worst category of "Digging In", meaning Defying Demands for Exit: companies defying demands for exit/reduction of activities. Medical device Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings . Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during
14274-623: Was adopted in 2017. The currct core legal framework consists of two regulations, replacing the previous three directives: The two regulations are supplemented by several guidances developed by the Medical Devices Coordination Group (MDCG). Article 2, Paragraph 4, of the Pharmaceutical Affairs Law (PAL) defines medical devices as "instruments and apparatus intended for use in diagnosis, cure or prevention of diseases in humans or other animals; intended to affect
14396-533: Was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide , a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In
14518-534: Was established by the 1902 Biologics Control Act , with additional authority established by the 1944 Public Health Service Act . Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health ; this authority was transferred to the FDA in 1972. The Center for Devices and Radiological Health (CDRH)
14640-511: Was listed on Bloomberg at just over $ 130 billion (or €115 billion). Medtronic's acquisition of Covidien made Medtronic the world's largest medical device company by revenues. During the 2022 Russian invasion of Ukraine , Medtronic refused to join the international community and withdraw from the Russian market. Research from Yale University updated on 28 April 2022, identifying how companies were reacting to Russia's invasion identified Medtronic in
14762-474: Was ranked as the world's largest medical device company by 2017 revenues (see table below). In March 2017, Bloomberg's database of U.S. tax inversions listed Medtronic and Wright Medical Group (Medtronic's 2015 inversion to Ireland was over $ 100 billion, while Wright's 2015 inversion to the Netherlands was $ 3.3 billion), as the only U.S. tax inversions of a U.S. medical device company in history. In February 2018,
14884-455: Was still winning U.S. Federal contracts and attending U.S. trade-missions as a U.S. company. In terms of scale, on 23 November 2018, Ireland's largest stockbrokers, Davy Stockbrokers reported that the total capitalization of the Irish stock market was €104 billion (this does not include Medtronic, which Davy do not consider an Irish company). In contrast, on the same day Medtronic's capitalization
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