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United States · Law · HR

H.R. 3095 (101st)

Safe Medical Devices Act of 1990

enactedUnited States· United States Congress· EN

Introduced

2 August 1989

Last action

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Status

Became Public Law No: 101-629.

Sponsors

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Subjects

Discovery layer

Source updated

3 June 2026

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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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9 official files

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