Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act. The Act mandates reporting requirements by medical device manufacturers regarding adverse safety events and product effectiveness of devices classified as substantially equivalent to Class III medical devices. The United States Statute established the Health and Human Services Office of International Relations and a U.S. Food and Drug Administration office for regulatory activities concerning healthcare products which are considered a combinational biological, device, or drug product.[1][2] The Act of Congress transferred the electronic product radiation control provisions established by the Radiation Control for Health and Safety Act.
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| Long title | An Act to amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes. |
|---|---|
| Enacted by | the 101st United States Congress |
| Effective | November 28, 1990 |
| Citations | |
| Public law | 101-629 |
| Statutes at Large | 104 Stat. 4511 |
| Codification | |
| Acts amended | |
| Titles amended | 21 U.S.C.: Food and Drugs |
| U.S.C. sections amended | 21 U.S.C. ch. 9, 21USC360i: Sec. 519, 21USC360i: Sec. 519a, 21USC360j: Sec. 520j, 21USC360c: Sec. 513f, 21USC360e: Sec. 515, 21USC360j: Sec. 520l, 21USC360c: Sec. 513(a)(l)(A)(ii), 21USC360c: Sec. 513(a)(l)(B), 21USC360c: 513(a)(1)(C), 21USC360c: Sec. 513e, 21USC360c: Sec. 513(f)(2)(A), 21USC360j: Sec. 520(1)(2), 21USC360c: Sec. 513(f), 21USC360d: Sec. 514, 21USC360d: Sec. 514(b), 21USC360j: Sec. 520(i), 21USC360i: Sec. 519, 21USC360h: Sec. 518, 21USC360e: Sec. 515(e), 21USC351: Sec. 501(f), 21USC360j: Sec. 520, 21USC360g: Sec. 517(a), 21USC353: Sec. 503, 21USC321: Sec. 201, 21USC333: Sec. 303, 21USC360c: Sec. 513(f)(2), 21USC360d: Sec. 514(b), 21USC360e: Sec. 515(c)(2), 21USC360f: Sec. 516(a), 21USC360j: Sec. 520(f)(l)(A), 21USC360j: Sec. 520(l)(2) |
| Legislative history | |
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Congressman Henry A. Waxman and Senator Edward M. Kennedy were the chairperson sponsors of the safe medical device amendments.[3] The H.R. 3095 legislation was passed by the 101st Congressional session and enacted by the 41st President of the United States George H. W. Bush on November 28, 1990.
History
editThe 1990 Safe Medical Device law originated after an eight-year U.S. congressional inquiry of the Medical Device Amendments of 1976. The 1976 legislation deviated the clarification and proper evaluation of competitive or "substantial equivalence" medical devices.[4]
The U.S. General Accounting Office presented exhibits for the legislative review which defined the vulnerabilities of the 510K premarket notification process. The 510K premarket approval program was cross-examined to discover qualified medical devices were disallowed from testing in some instances, inadequately tested in a clinical setting, and deficient in adverse data collection oversight.[5]
The U.S. congressional review concluded medical devices would require actual device experience in a clinical setting and sufficient reporting of adverse data events. The legislation would encompass medical devices demonstrating the potential for life-threatening events and accurate adverse data collection would be required for informed regulatory decisions.[6]
References
edit- ^ "Office of Global Affairs". International Relations Division. U.S. Department of Health and Human Services.
- ^ "Combination Products". Office of Combination Products. U.S. Food and Drug Administration. 31 October 2019.
- ^ 101st U.S. Congress (August 2, 1989). "H.R.3095: Safe Medical Devices Act of 1990". U.S. House of Representative Bill Summary & Status. Library of Congress THOMAS. Retrieved March 16, 2013.
{{cite web}}: CS1 maint: numeric names: authors list (link)[permanent dead link] - ^ "Use of Standards in Substantial Equivalence Determinations". Device Advice: Comprehensive Regulatory Assistance. U.S. Food and Drug Administration. March 12, 2000. Retrieved March 23, 2013.
- ^ "Premarket Notification (510k)". Device Advice: Comprehensive Regulatory Assistance. U.S. Food and Drug Administration. September 3, 2010. Retrieved March 20, 2013.
- ^ Samuel, Frank E Jr. (1991). "Safe Medical Devices Act Of 1990" (PDF). Health Affairs. 10 (1): 192–195. doi:10.1377/hlthaff.10.1.192. PMID 2045049. S2CID 29697299. Retrieved March 18, 2013.
External links
edit- "Health Care: Federal Regulation of Medical Devices--Problems Still To Be Overcome" (PDF). gao.gov. U.S. Government Accountability Office. September 30, 1983. OCLC 226405143.
- "Medical Devices: FDA's 510(k) Operations Could Be Improved" (PDF). gao.gov. U.S. Government Accountability Office. August 17, 1988. OCLC 18759600.