Safe Medical Devices Act of 1990 (H.R. 3095 (101st)) — United States

Summary

Safe Medical Devices Act of 1989 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require medical device user 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 has or will seriously malfunction. Defines "medical device user facility" (MDUF) to mean a hospital, ambulatory surgical facility, outpatient diagnostic or treatment facility which is not a physician's office, or a nursing home. Prohibits retaliation against MDUF personnel or practitioners who file reports. Gives U.S. district courts jurisdiction over civil actions for damages for retaliation. Establishes civil penalties against MDUFs for knowing failure to report. Directs the Secretary to: (1) conduct a study of compliance with these provisions and prevents them from going into effect if the Secretary finds substantial compliance; and (2) conduct education and information programs for MDUFs respecting these requirements. Directs the Comptroller General to study compliance by MDUFs and the actions taken by the manufacturers in response to reports. Directs the Secretary to amend Federal regulations to require distributors of medical devices to establish and maintain records and make reports under these provisions. Amends the FDCA to require distributors to submit copies of certain reports to the manufacturer of the device for which the report was made. Requires each manufacturer, importer, and distributor required by existing law and regulations thereunder to make reports to submit to the Secretary annually a certification that: (1) they did not file any report because there were no events requiring a report; or (2) they did file reports of all events of which they had information. Directs the Secretary to require: (1) every person who registers under existing provisions as a producer of drugs or devices and is engaged in the manufacture of a class III device to assign a model or other identification number to each device and to maintain certain records; and (2) every individual or entity which sells or uses a class III device to maintain certain records to ensure that patients who receive the devices can be provided the notification authorized by existing provisions. Amends the FDCA to add the failure or refusal to submit any report required by or under the Act to the list of prohibited acts. Allows a device, for purposes of provisions relating to classification of devices and relating to premarket approval, to be considered substantially equivalent to another device only if the Secretary by order finds it has the same intended use and: (1) the same technological characteristics; or (2) different technological characteristics, in which case it must be demonstrated that it is as safe and effective as comparable devices which are currently being sold in interstate commerce. Adds such order to the list of information to be made available to the public. Requires a manufacturer, in certain circumstances, to certify that it has conducted a search of all information known to the manufacturer and all published information respecting a substantially equivalent device and has included in a specified report a description of and a citation to all adverse safety and effectiveness data. Allows the Secretary to require the manufacturer to submit the adverse data described in the report. Directs the Secretary to: (1) require manufacturers of devices which are subject to reclassification under this Act to submit a description of and a citation to any adverse safety or effectiveness information, and authorizes the Secretary to require the submission of the described or cited data; and (2) reclassify certain class III devices as class I, class II, or class III, using the criteria in existing classification provisions. Adds the failure or refusal to furnish certain information as required by this Act to the list of prohibited acts. Amends provisions establishing classes of devices to allow class II, which currently involves performance standards, to involve special controls including, but not limited to, performance standards. Authorizes the Secretary to change the classification of a device from class III to class II or class I if the Secretary determines that the controls at each of those levels would provide reasonable assurance of the safety and effectiveness of the device. 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 remedies. Directs the Secretary to require a manufacturer, importer, or distributor of a device to report any removal or field repair of a device undertaken to eliminate a health risk or to remedy a violation of this Act. Requires recordkeeping of repairs or removals which are not required to be reported. Requires the Secretary to support education and training activities to minimize the exposure of people to health hazards associated with devices. Requires the effectiveness of a device to be determined on the basis of well-controlled investigations irrespective of the sponsor of the investigations. (Current law requires well-controlled investigations, but makes no reference to the sponsor.) Allows the Secretary, for good cause shown, to refer a classifying petition to a classification panel. (Current law requires the Secretary to refer a petition to a panel.) Revises procedures for: (1) establishing and amending performance standards; (2) processing premarket approval applications; (3) banning devices; and (4) processing petitions, under specified transitional provisions, for classifications of a device in class I or II. Transfers provisions of the Public Health Service Act relating to electronic product radiation control to the FDCA. Provides that the regulation of medical devices used to deliver electro-convulsive therapy is not affected by this Act.

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Timeline

2 August 1989
Introduced
Referred to the House Committee on Energy and Commerce.
Source: IntroReferral
2 August 1989
Introduced
Introduced in House
Source: IntroReferral
2 August 1989
Introduced
Introduced in House
Source: IntroReferral
1 September 1989
Referred
Referred to the Subcommittee on Health and the Environment.
Source: Committee
17 July 1990
Committee
Subcommittee Hearings Held.
Source: Committee
24 September 1990
Committee
Subcommittee Consideration and Mark-up Session Held.
Source: Committee
25 September 1990
Committee
Subcommittee Consideration and Mark-up Session Held.
Source: Committee
25 September 1990
Committee
Forwarded by Subcommittee to Full Committee (Amended).
Source: Committee
26 September 1990
Committee
Committee Consideration and Mark-up Session Held.
Source: Committee
26 September 1990
Reported
Ordered to be Reported (Amended).
Source: Committee
28 September 1990
Passed
Mr. Tauzin asked unanimous consent that the Committee on Energy and Commerce have until midnight on Sept. 28 to file a report on H.R. 3095. Agreed to without objection.
Source: Committee
5 October 1990
Calendars
Placed on the Union Calendar, Calendar No. 505.
Source: Calendars
5 October 1990
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 101-808.
Source: Committee
5 October 1990
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 101-808.
Source: Committee
10 October 1990
Passed
Motion to reconsider laid on the table Agreed to without objection.
Source: Floor
10 October 1990
Passed
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
Source: Floor
10 October 1990
Passed
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
Source: Floor
10 October 1990
Floor
DEBATE - The House proceeded with forty minutes of debate.
Source: Floor
10 October 1990
Calendars
The chair announced that a second on the motion to suspend the rules is not required.
Source: Calendars
10 October 1990
Floor
Considered under suspension of the rules.
Source: Floor
10 October 1990
Floor
Mr. Waxman moved to suspend the rules and pass the bill, as amended.
Source: Floor
12 October 1990
ResolvingDifferences
Senate insists on its amendments, asks for a conference, appoints conferees Kennedy; Pell; Metzenbaum; Dodd; Hatch; Durenberger; Coats.
Source: ResolvingDifferences
12 October 1990
Passed
Passed/agreed to in Senate: Passed Senate in lieu of S. 3006 with an amendment by Voice Vote.
Source: Floor
12 October 1990
Floor
Measure laid before Senate by unanimous consent.
Source: Floor
15 October 1990
Floor
Message on Senate action sent to the House.
Source: Floor
17 October 1990
Passed
Motion to reconsider laid on the table Agreed to without objection.
Source: ResolvingDifferences
17 October 1990
Floor
The Speaker reserved the right to make additional appointments.
Source: Floor
17 October 1990
ResolvingDifferences
The chair appointed conferees: Dingell, Waxman, Wyden, Lent, and Madigan.
Source: ResolvingDifferences
17 October 1990
ResolvingDifferences
Mr. Waxman asked unanimous consent that the House disagree to the Senate amendment, and agree to a conference.
Source: ResolvingDifferences
17 October 1990
Passed
On motion that the House disagree to the Senate amendment, and agree to a conference Agreed to without objection.
Source: ResolvingDifferences
26 October 1990
ResolvingDifferences
Conference report H. Rept. 101-959 filed.
Source: ResolvingDifferences
26 October 1990
ResolvingDifferences
Conference report filed: Conference report H. Rept. 101-959 filed.
Source: ResolvingDifferences
27 October 1990
Floor
Message on Senate action sent to the House.
Source: Floor
27 October 1990
ResolvingDifferences
Conference papers: Senate report and managers' statement and message on House action held at the desk in Senate.
Source: ResolvingDifferences
27 October 1990
Passed
Conference report agreed to in Senate: Senate agreed to conference report by Voice Vote.
Source: ResolvingDifferences
27 October 1990
Passed
On agreeing to the conference report Agreed to by voice vote.
Source: ResolvingDifferences
27 October 1990
Passed
Motions to reconsider laid on the table Agreed to without objection.
Source: ResolvingDifferences
27 October 1990
Passed
Conference report agreed to in House: On agreeing to the conference report Agreed to by voice vote.
Source: ResolvingDifferences
27 October 1990
Floor
DEBATE - The House proceeded with forty minutes of debate.
Source: Floor
27 October 1990
ResolvingDifferences
Mr. Whittaker demanded a second on the motion to suspend the rules and agree to the conference report. Without objection a second is ordered.
Source: ResolvingDifferences
27 October 1990
ResolvingDifferences
Mr. Waxman moved to suspend the rules and agree to the conference report, H. Rept. 101-959.
Source: ResolvingDifferences
19 November 1990
Floor
Presented to President.
Source: Floor
19 November 1990
President
Presented to President.
Source: President
19 November 1990
Floor
Measure Signed in Senate.
Source: Floor
28 November 1990
Became law
Became Public Law No: 101-629.
Source: President
28 November 1990
Became law
Signed by President.
Source: BecameLaw
28 November 1990
President
Signed by President.
Source: President

Votes

No vote records are attached yet.

Versions

Engrossed Amendment Senate · — · Download file
Engrossed in House · — · Download file
Enrolled Bill · — · Download file
Introduced in House · — · Download file
Received in Senate · — · Download file
Reported in House · — · Download file

Documents

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Reported in House (text)

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Reported in House (text)
Reported in House · EN
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Received in Senate (text)
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Introduced in House (text)
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Enrolled Bill (text)
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Engrossed in House (text)
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Engrossed Amendment Senate (text)
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Public Law (PDF)
Public Law · EN · 29 November 1990
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Conference report filed in House
summary · EN · 26 October 1990
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Introduced in House
summary · EN · 2 August 1989
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Related records

related to ← Comprehensive Medical Device Improvement Act of 1990

Related across the Repo ecosystem

Direct relationships are identifier-backed. Topic context means shared TopicMembership — not a citation and not causation.

Direct relationships

Legal framework · Safe Medical Devices Act of 1990 · H.R. 3095 (101st) · US

Identifier matchPROJECTS_FROM
Same us record 101-hr-3095 projected from PoliticalRepo US row.
Safe Medical Devices Act of 1990

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/101st-congress/house-bill/3095
Open data entity: https://api.congress.gov/v3/bill/101/hr/3095
us · 101-hr-3095 · source updated 3 June 2026

Safe Medical Devices Act of 1990