129:, published in 2018 in the policy journal Milbank Quarterly, investigated whether studies reviewed by the FDA for high-risk medical devices are proven safe and effective for women, racial or ethnic minorities, or patients over 65 years of age. The law encourages patient diversity in clinical trials submitted to the FDA for review, but does not require it. The study determined that most high-risk medical devices are not tested and analyzed to ensure that they are safe and effective for all major demographic groups, particularly racial and ethnic minorities and people over 65. Therefore, they do not provide information about safety or effectiveness that would help patients and physicians make well informed decisions.
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122:, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, cheaper 510(k) process. In a few cases, the devices had been deemed so low-risk that they did not undergo any FDA regulatory review. Of the 113 devices recalled during the 5 year period, 35 were for cardiovascular issues. This study was the topic of Congressional hearings re-evaluating FDA procedures and oversight.
95:, results in FDA clearance of a product. The intent of this class was for new manufacturers of devices that already existed when the rules were established. A Class 2 device is required to be "substantially equivalent" to existing devices. The class is now used for "medium risk" devices such as demineralized bone powder used for reconstructive surgery, which is officially substantially equivalent to
135:
require a "Pre-market
Approval" (PMA), which is analogous to the drug approval process with clinical trials and extensive review of the design. Class 3 devices tend to be products such as pacemakers which would cause obvious risk of injury or death if they did not function properly. As with all
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The Bureau of
Medical Devices was established within FDA in 1973, and merged with the Bureau of Radiological Health in 1982 to form the Center for Devices and Radiological Health. The merge was the result of the beginning of the
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include everyday items such as toothbrushes which are unlikely to cause serious consequences if they fail. Manufacturers are required to follow what are called "general controls" which closely match
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99:, a much older product that was used for the same purpose. This equivalence is used when the FDA does not think a full approval process with extensive clinical trials is necessary.
156:, it became the Bureau of Radiological Health within the Environmental Control Administration in 1968. When the Environmental Control Administration was transformed into the
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in 1971, the Bureau of
Radiological Health's personnel and facilities were split, with portions of it transferred to EPA, while the remainder became part of the FDA.
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47:, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of
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reorganizing the FDA to merge the bureaus responsible for medical devices and radiation control into their present form.
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require a premarket notification. This process, commonly known as the "510(k)" process after the relevant section of the
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Redberg and Dhruva. "Medical Device
Recalls: Comment on 'Medical Device Recalls and the FDA Approval Process.'"
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FDA Laboratory
Building 62 (Engineering and Physics) houses the Center for Devices and Radiological Health.
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served as director of the Bureau of
Radiological Health and then the merged center from 1969 until 1990.
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The premarket notification process came under fire in
February 2011 after the release of a study by Dr.
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CDRH splits medical devices into three classes with different regulatory requirements:
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Reid, Ken. "CBER and CDER have long history of being lumped together and split up."
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Regulation of food and dietary supplements by the U.S. Food and Drug
Administration
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Zuckerman et al. "Medical Device
Recalls and the FDA Approval Process."
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CDRH's earliest predecessor was the
Radiological Health Unit within the
315:. U.S. Department of Health, Education, and Welfare. 1957. p. 25.
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devices, the manufacturers must follow the general controls.
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A study by Dr. Stephanie Fox-Rawlings and colleagues at the
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Executive Reference Book (Public Health Service Portion)
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39:(FDA) responsible for the premarket approval of all
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557:Title 21 of the Code of Federal Regulations (CFR)
511:Family Smoking Prevention and Tobacco Control Act
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152:, which was established in 1948. As part of the
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206:. Food and Drug Administration. Archived from
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461:Center for Food Safety and Applied Nutrition
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745:History of the Food and Drug Administration
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87:In addition to the general controls,
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168:blurring the lines between drugs,
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334:U.S. Food and Drug Administration
290:U.S. Food and Drug Administration
66:, who took over in January 2010.
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154:PHS reorganizations of 1966–1973
62:The current head of the CDRH is
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763:Commissioner of Food and Drugs
545:Title 21 regulations and rules
531:Prescription Drug User Fee Act
471:Center for Veterinary Medicine
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526:Food Safety Modernization Act
120:Archives of Internal Medicine
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428:Food and Drug Administration
355:Bioresearch Monitoring Alert
43:, as well as overseeing the
37:Food and Drug Administration
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390:Radiation-Emitting Products
93:Food, Drug and Cosmetic Act
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740:FDA Most Wanted Fugitives
516:Modernization Act of 1997
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49:electromagnetic radiation
166:biotechnology revolution
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32:) is the branch of the
536:Pure Food and Drug Act
106:and Paul Brown of the
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694:Andrew von Eschenbach
569:Federal Register (FR)
243:2011; 0: 2011301-6.
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649:Alexander M. Schmidt
263:2011; 0: 2011271-2.
728:Society and culture
664:Arthur H. Hayes Jr.
624:Charles W. Crawford
357:Sept. 2002. page 4.
210:on January 19, 2012
118:, published in the
84:9000 requirements.
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614:Walter G. Campbell
552:Administrative law
70:Regulatory classes
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609:Charles A. Browne
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330:"CDRH Leadership"
286:"CDRH Milestones"
112:Dr. Steven Nissen
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634:James L. Goddard
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336:. p. 3
778:Categories
504:Major acts
340:2020-10-01
296:2020-08-29
190:References
51:, such as
439:Divisions
170:biologics
249:21321283
430:of the
269:1321286
140:History
114:of the
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214:May 6,
172:, and
148:(PHS)
110:, and
265:PMID
245:PMID
216:2024
55:and
30:CDRH
24:The
82:ISO
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59:.
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28:(
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