Medical Device Amendments of 1992

Summary

Medical Device Amendments of 1992 - Amends the Safe Medical Devices Act of 1990 to extend the deadline for the Food and Drug Administration (FDA) to issue final regulations under the Federal Food, Drug, and Cosmetic Act (FFDC Act) with respect to medical device tracking until November 28 (currently, May 28), 1992. Specifies that if the Secretary does not promulgate such final regulations by that date, the proposed regulations shall become the final regulations and the FDA shall promptly publish in the Federal Register notice of the new status. Makes: (1) failure to comply with a requirement imposed by provisions of the FFDC Act concerning postmarket surveillance a prohibited act subject to criminal and civil penalties; and (2) any device product misbranded if there was a failure or refusal to comply with postmarket surveillance requirements. Directs each manufacturer required to conduct a surveillance of a device to submit, for the approval of the Secretary of Health and Human Services, a protocol for the required surveillance. Authorizes the FDA to order a manufacturer, importer, or distributor to repair or replace a device, or refund the purchase price to the customer, where the device was improperly designed or manufacturered. Revises reporting requirements, including adding requirements for: (1) a device manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices may have caused or contributed to a death or serious injury (defined as an injury that is life threatening, results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude such permanent impairment or damage), or has malfunctioned and that such device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; and (2) reporting of other significant adverse device experiences as determined by the Secretary to be necessary to be reported.

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Timeline

1. 21 May 1992

   Introduced

   Introduced in the Senate, read twice, considered, read the third time, and passed without amendment by Voice Vote.

   Source: Floor

2. 21 May 1992

   Introduced

   Passed/agreed to in Senate: Introduced in the Senate, read twice, considered, read the third time, and passed without amendment by Voice Vote.

   Source: Floor

3. 21 May 1992

   Introduced

   Introduced in Senate

   Source: IntroReferral

4. 26 May 1992

   Floor

   Held at the desk.

   Source: Floor

5. 26 May 1992

   Floor

   Received in the House.

   Source: Floor

6. 28 May 1992

   Passed

   Motion to reconsider laid on the table Agreed to without objection.

   Source: Floor

7. 28 May 1992

   Passed

   On passage Passed without objection.

   Source: Floor

8. 28 May 1992

   Passed

   Passed/agreed to in House: On passage Passed without objection.

   Source: Floor

9. 28 May 1992

   Floor

   Mr. Waxman asked unanimous consent to take from the Speaker's table and consider.

   Source: Floor

10. 28 May 1992

    Floor

    Considered by unanimous consent.

    Source: Floor

11. 2 June 1992

    Floor

    Message on House action received in Senate.

    Source: Floor

12. 4 June 1992

    Floor

    Presented to President.

    Source: Floor

13. 4 June 1992

    President

    Presented to President.

    Source: President

14. 16 June 1992

    Became law

    Became Public Law No: 102-300.

    Source: President

15. 16 June 1992

    Became law

    Signed by President.

    Source: BecameLaw

16. 16 June 1992

    President

    Signed by President.

    Source: President

Votes

No vote records are attached yet.

Versions

• Considered and Passed Senate · undated · Official file
• Enrolled Bill · undated · Official file
• Engrossed in Senate · undated · Official file

Documents

5 official files

• Engrossed in Senate (text)

  Engrossed in Senate · EN

  ViewDownloadOpen at official source

• Enrolled Bill (text)

  Enrolled Bill · EN

  ViewDownloadOpen at official source

• Considered and Passed Senate (text)

  Considered and Passed Senate · EN

  ViewDownloadOpen at official source

• Public Law (PDF)

  Public Law · EN · 17 June 1992

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 21 May 1992

  Open at official source

Sponsors

• Sen. Kennedy, Edward M. [D-MA] · D · Sponsor
• Sen. Hatch, Orrin G. [R-UT] · R · Sponsor

Related records

No cross-record relationships stored yet.