H.R. 3095 · 101st Congress · enacted
Safe Medical Devices Act of 1990
Became Public Law No: 101-629.
Latest official action 1990-11-28 · Enacted
The bill, briefly
Safe Medical Devices Act of 1990 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require medical device user facilities to report to the Secretary of Health and Human Services, the manufacturer, or both whenever they believe there is a probability that a medical device has caused or contributed to a death, illness, or injury. Defines a medical "device user facility" (DUF) to mean a hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility which is not a physician's office. Prohibits the Secretary, subject to exception, from disclosing the identity of a DUF which makes a report. Prohibits a report from being used in any civil action involving private parties unless the report maker had knowledge of the falsity of the report. Requires the Comptroller General to study compliance by DUFs with these reporting requirements, actions taken by manufacturers in response to reports, and the cost effectiveness of the requirements and their implementation. Requires each manufacturer, importer, and distributor to annually certify to the Secretary the number of reports it filed, or that it filed no reports. Requires manufacturers of devices to adopt a method of device tracking. Requires a manufacturer of certain devices which are substantially equivalent to a class III device to certify to the Secretary that the manufacturer has conducted a search of…
Congressional Research Service · 1990-10-26
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.
3 of 3 source cosponsor records retrieved; only current officials and unwithdrawn sponsorships appear.
PAC donors to the listed sponsors
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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.