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.

Congressman Henry A. Waxman and Senator Edward M. Kennedy were the chairperson sponsors of the safe medical device amendments.

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.

[4] The U.S. General Accounting Office presented exhibits for the legislative review which defined the vulnerabilities of the 510K premarket notification process.

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.