Safe Medical Device Amendments of 1990

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Safe Medical Device Amendments of 1990
Great Seal of the United States.
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
Public Law 101-629
Stat. 104 Stat. 4511
Act(s) amended
Title(s) amended 21 U.S.C.: Food and Drugs
U.S.C. section(s) 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
  • Introduced in the House of Representatives as H.R. 3095 by Henry Waxman (DCA) on August 2, 1989
  • Committee consideration by: Committee on Energy and Commerce
  • Passed the House on October 10, 1990 (Agreed by Voice Vote)
  • Passed the Senate on October 12, 1990 (Agreed by Voice Vote) with amendment
  • House agreed to Senate amendment on October 27, 1990 (Agreed by Voice Vote) with further amendment
  • Senate agreed to House amendment on October 27, 1990 (Agreed by Voice Vote)
  • Signed into law by President George H. W. Bush on November 28, 1990

The Safe Medical Device Amendments of 1990 or Comprehensive Medical Device Improvement Act of 1990 was introduced by the 101st Congress of the United States. Congressman Henry A. Waxman and Senator Edward M. Kennedy were the chairperson sponsors of the safe medical device amendments.[1] The Title 21 amendments were signed into law on November 28, 1990 by the 43rd President of the United States George H. W. Bush.

The U.S. legislation enacted in 1990 amended the Medical Device Amendments of 1976 signed by the 38th President of the United States Gerald R. Ford.


The 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.[2]

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.[3]

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.[4]


  1. ^ 101st U.S. Congress (August 2, 1989). "H.R.3095: Safe Medical Devices Act of 1990". U.S. House of Representative Bill Summary & Status (in English). Library of Congress THOMAS. Retrieved March 16, 2013. 
  2. ^ "Use of Standards in Substantial Equivalence Determinations". Device Advice: Comprehensive Regulatory Assistance (in English). U.S. Food and Drug Administration. March 12, 2000. Retrieved March 23, 2013. 
  3. ^ "Premarket Notification (510k)". Device Advice: Comprehensive Regulatory Assistance (in English). U.S. Food and Drug Administration. September 3, 2010. Retrieved March 20, 2013. 
  4. ^ Samuel, Jr., Frank E (1991). "Safe Medical Devices Act Of 1990". Health Affairs, 10, no.1 (1991):192-195. At the Intersection of Health, Health Care and Policy (in English). Health Affairs. p. 3-4. Retrieved March 18, 2013.