S. 2783 · 102nd Congress · enacted
Medical Device Amendments of 1992
Became Public Law No: 102-300.
Latest official action 1992-06-16 · Enacted
The bill, briefly
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 manu…
Congressional Research Service · 1992-05-21
Who reported lobbying on this bill?
Amount spent specifically on this bill: not disclosed
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2,409 latest lobbying reports imported. Some source imports are still in progress.
Politicians behind the bill
Sponsors and cosponsors from the official source, limited to members currently in office. Campaign amounts are cycle-wide and are not payments for this bill.
1 of 1 source cosponsor records retrieved; only current officials and unwithdrawn sponsorships appear.
PAC donors to the listed sponsors
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The largest 40 donor totals appear here. Open each politician for their complete, paginated PAC donor list.
What happened after enactment?
Dated agency-reported implementation and uptake measures are shown with their scope. They do not by themselves establish causal success. If no evidence is listed, the outcome is not established.