Medical Device Improvements Act of 1987

Summary

Medical Device Improvements Act of 1987 - Amends the Federal Food, Drug, and Cosmetic Act to require medical facilities to inform the Secretary of Health and Human Services and the manufacturer whenever they believe a medical device could have contributed to a death, illness, or injury, or may have seriously malfunctioned. Establishes civil penalties for knowing violations. Requires manufacturers to maintain records of such information. Authorizes the Secretary to waive application requirements for premarket approval for a class III device. Defines "substantially identical" for purposes of classifying devices, requiring same intended use and same technological characteristics. Requires the submission of clinical data demonstrating the substantial equivalence of a device, defined as having the same intended use as another device, but different technological characteristics. Requires a person seeking substantial identity or equivalence to a class III device to certify that a search of published information on such device has been concluded and may be required to include relevant adverse safety and effectiveness data. Requires the Secretary within five years to reclassify class III devices into class I or into class II or to state that the classification is appropriate. Revises existing standards to designate as class II devices those devices for which it can be determined whether or not a performance standard is appropriate rather than requiring a performance standard as under current law. Authorizes the Secretary of Health and Human Services to reclassify class III devices (devices requiring premarket approval) into class I (devices requiring general controls) or class II as appropriate to assure the safety and effectiveness of such devices. Revises the procedures for establishing performance standards for devices. Removes the non-state-of-the-art design and manufacture basis for repair, replacement, or refund remedy. Eliminates devices from the color additives regulation. Requires the Secretary to support education and training activities to minimize the exposure of people to health hazards associated with devices. Makes it discretionary rather than mandatory to refer device applications to a panel for evaluation. Amends the Orphan Drug Act to include medical devices.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 3 June 1987

   Introduced

   Referred to House Committee on Energy and Commerce.

   Source: IntroReferral

2. 3 June 1987

   Introduced

   Introduced in House

   Source: IntroReferral

3. 3 June 1987

   Introduced

   Introduced in House

   Source: IntroReferral

4. 15 June 1987

   Referred

   Referred to Subcommittee on Health and the Environment.

   Source: Committee

5. 17 May 1988

   Committee

   Forwarded by Subcommittee to Full Committee.

   Source: Committee

6. 17 May 1988

   Committee

   Subcommittee Consideration and Mark-up Session Held.

   Source: Committee

7. 26 July 1988

   Committee

   See H.R.4640.

   Source: Committee

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

1 official file

• Introduced in House

  summary · EN · 3 June 1987

  Open at official source

Sponsors

• Rep. Waxman, Henry A. [D-CA-33] · D · Sponsor
• Rep. Dingell, John D. [D-MI-12] · D · Sponsor
• Rep. Swift, Al [D-WA-2] · D · Cosponsor
• Rep. McCloskey, Frank [D-IN-8] · D · Cosponsor
• Rep. Lowry, Mike [D-WA-7] · D · Cosponsor
• · hsif00 · Standing

Related records

• related to ← Medical Device Improvements Act of 1988