View source for Medicine:Medical Device Regulation Act

{{Infobox U.S. legislation
| name            = Medical Device Amendments of 1976
| fullname        = An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes.
| acronym         = 
| nickname        = 
| enacted by      = 94th
| effective date  = May 28, 1976
| public law url  = http://www.gpo.gov/fdsys/pkg/STATUTE-90/pdf/STATUTE-90-Pg539.pdf
| cite public law = 94-295
| cite statutes at large = {{usstat|90|539}}
| acts amended    = Federal Food, Drug and Cosmetic Act
| acts repealed   = 
| title amended   = 21 U.S.C.: Food and Drugs
| sections created = {{Usc-title-chap|21|9|V}} §§ 360c:Sec. 513, 360d:Sec. 514, 360e:Sec. 515, 360f:Sec. 516, 360g:Sec. 517, 360h:Sec. 518, 360i:Sec. 519, 360j:Sec. 520, 360k:Sec. 521
| sections amended = {{unbulleted list|{{Usc-title-chap|21|9|II}} § 321|{{Usc-title-chap|21|9|III}} §§ 331, 334|{{Usc-title-chap|21|9|V}} §§ 351, 352, 358, 360|{{Usc-title-chap|21|9|VII}} §§ 374, 379e|{{Usc-title-chap|21|9|VIII}} § 381}}
| leghisturl= http://thomas.loc.gov/cgi-bin/bdquery/z?d094:HR11124:
| introducedin= Senate
| introducedbill= {{USBill|94|S.|510}}
| introducedby= Edward M. Kennedy (D–{{wipe|Massachusetts}})
| introduceddate= January 30, 1975
| committees= Senate Committee on Commerce
Senate Committee on Labor and Public Welfare
House Committee on Interstate and Foreign Commerce
| passedbody1= House
| passeddate1= March 9, 1976
| passedvote1= [http://www.govtrack.us/congress/votes/94-1976/h680 362-32]
| passedbody2= Senate
| passeddate2= April 17, 1975
| passedvote2= [http://www.govtrack.us/congress/votes/94-1975/s139 88-5], in lieu of {{USBill|94|H.R.|11124}}
| conferencedate= May 13, 1976
| agreedbody3= House
| agreeddate3= May 13, 1976
| agreedvote3= cleared
| agreedbody4= Senate
| agreeddate4= May 13, 1976
| agreedvote4= cleared
| signedpresident = Gerald R. Ford
| signeddate      = May 28, 1976
|unsignedpresident=|vetoedpresident=| amendments      = [[Medicine:Safe Medical Device Amendments of 1990|Safe Medical Device Amendments of 1990]]
| SCOTUS cases    = 
}}
The '''Medical Device Regulation Act''' or '''Medical Device Amendments of 1976''' was introduced by the 94th Congress of the United States. Congressman Paul G. Rogers and Senator Edward M. Kennedy were the chairperson sponsors of the medical device amendments.<ref>{{cite web |url=http://thomas.loc.gov/cgi-bin/bdquery/z?d094:HR11124: |title=H.R.11124: Medical Device Amendments |author=94th U.S. Congress |date=December 11, 1975 |work=U.S. House of Representative Bill Summary & Status |publisher=Library of Congress THOMAS |accessdate=February 9, 2013 }}{{Dead link|date=August 2021 |bot=InternetArchiveBot |fix-attempted=yes }}</ref><ref>{{Cite web|url=https://www.congress.gov/bill/94th-congress/senate-bill/510|title=S.510: An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes.|last=94th U.S. Congress|date=May 28, 1976|website=www.congress.gov|language=en|access-date=2018-11-29}}</ref> The Title 21 amendments were signed into law on May 28, 1976, by the 38th President of the United States Gerald R. Ford.<ref>{{cite web |url = http://www.presidency.ucsb.edu/ws/index.php?pid=6069 |title = Gerald R. Ford: "Statement on Signing the Medical Device Amendments of 1976.," May 28, 1976 |author1= Gerhard Peters |author2 = John T. Woolley |publisher = University of California - Santa Barbara |work = The American Presidency Project |accessdate= 10 February 2013}}</ref>

The U.S. legislation enacted in 1976 amended the Food, Drug, and Cosmetic Act of 1938 signed by the 32nd President of the United States Franklin D. Roosevelt.<ref>{{cite web |url = https://research.archives.gov/description/299847 |title = Federal Food, Drug, and Cosmestic Act of June 25, 1938, Public Law 75-717, 52 Stat 1040 |author= Office of the Federal Register |publisher = U.S. National Archives and Records Administration |work = Enrolled Acts and Resolutions of Congress, Compiled 1789-2008 |accessdate= 12 February 2013}}</ref>

==History==
During the 1960s, the Secretary of Health, Education, and Welfare (HEW) commissioned the Cooper Committee to study the adverse effects of medical devices for human use. In 1970, the study committee recommended a classification for medical devices based on comparative risk.<ref>{{cite web |url=https://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/MedicalDeviceandRadiologicalHealthRegulationsComeofAge/ |title=The Medical Device Amendments of 1976 |author=Rados, Carol |date=January–February 2006 |work=FDA Consumer magazine - The Centennial Edition |series=Medical Device and Radiological Health Regulations Come of Age |publisher=U.S. Food and Drug Administration |accessdate=March 20, 2013}}</ref> In 1976, the [[Social:Dalkon Shield|Dalkon Shield]] intrauterine device injured at least 900,000 women in the United States,<ref>{{cite book|last1=Hicks|first1=Karen M|title=Surviving the Dalcon Shield IUD: Women v. The Pharmaceutical Industry|date=1994|publisher=Teachers College Press|location=New York}}</ref> which aided the emphasis for regulatory oversight and therapeutic requirements provided by the U.S. legislation P.L. 94-295.<ref>{{cite web |url=https://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm055137.htm |title=Regulating Cosmetics, Devices, and Veterinary Medicine After 1938 |author=Swann, Ph.D., John P |series=FDA History - Part IV |publisher=U.S. Food and Drug Administration |accessdate=9 February 2013}}</ref>

==Provisions of the Act==

'''Classification of Medical Devices'''<br />
There are three classifications for medical devices:
:* ''Class I - General Controls'' for devices considered as low risks for human use.
::Medical device has sufficient information to provide reasonable assurance of the safety and effectiveness of the device. Medical device is not to be for a use in supporting or sustaining human life, for a use which is of substantial importance in preventing impairment of human health, and does not present a potential unreasonable risk of illness or injury.
:* ''Class II - Performance Standards'' for devices considered as moderate risks for human use.
::Medical device has insufficient information to provide reasonable assurance of the safety and effectiveness of the device. Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device has sufficient information to establish a performance standard and it is necessary to establish a performance standard for the device.
:* ''Class III - Premarket Approval'' for devices considered as high risks for human use.
::Medical device cannot be classified as a class I device because insufficient information exists to determine that the controls authorized are sufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness of the device. Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury, is to be subject, premarket approval to provide reasonable assurance of its safety and effectiveness.

'''Classification Panels for Medical Devices'''<br />
:* Classification panels are to determine which devices intended for human use should be subject to the requirements of ''class I - general controls'', ''class II - performance standards'', or ''class III - premarket approval''.
:* Classification panels are to provide notice to the manufacturers and importers of medical devices intended for human use.
:* Manufacturers and importers are to prepare for the application of such requirements and to report medical devices intended for human use manufactured or imported by them.
:* Panel appointments shall consist of members with adequately diversified expertise in such fields as biological and physical sciences, clinical and administrative medicine, engineering, and other related professions. Persons who are qualified by training and experience to evaluate the safety and effectiveness of medical devices or possess skills in the use of, experience in the development, manufacture, or utilization of such medical devices.
:* No individual who is in the regular full-time employment of the United States and engaged in the administration of this Act may be a member of any medical device classification panel.

==References==
{{Reflist}}

==External links==
* {{cite web |url=https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ |title=FDA Classification of Medical Devices |date=22 October 2020 |publisher=U.S. Food and Drug Administration}}
* {{cite web |url=https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/ |title=FDA Medical Device Registration and Listing |date=30 September 2022 |publisher=U.S. Food and Drug Administration}}
* {{cite web |url=https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ |title=FDA Overview of Medical Device Regulation |date=4 September 2020 |publisher=U.S. Food and Drug Administration}}

[[Category:Health care quality]]

{{Sourceattribution|Medical Device Regulation Act}}