Medical Device Regulatory Flexibility Act
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (May 1, 1997)
Medical Device Regulatory Flexibility Act - Amends the Federal Food, Drug, and Cosmetic Act to modify requirements regarding the initial classification of medical devices.
Authorizes the Secretary of Health and Human Services to issue notices to identify and list nationally and internationally recognized standards that: (1) shall be the special controls to which class II devices must comply; (2) may be used in establishing (for device classification) the equivalence of one device to another; and (3) may be used in considering premarket approval of a class III device. Directs the Secretary to accept a certification that a device conforms to such a standard.
What just happenedMay 7, 1997
Referred to the Subcommittee on Health and Environment.
Who’s behind it
- Introduced in HouseMay 1, 1997
- May 7, 1997CommitteeH11000
Referred to the Subcommittee on Health and Environment.
Health and Environment Subcommittee - May 1, 1997IntroReferralH11100
Referred to the House Committee on Commerce.
Energy and Commerce Committee - May 1, 1997IntroReferralB00100
Sponsor introductory remarks on measure. (CR E813-814)
- May 1, 1997IntroReferralIntro-H
Introduced in House
- May 1, 1997IntroReferral1000
Introduced in House