Medical Technology, Public Health, and Innovation Act of 1995

Summary

Medical Technology, Public Health, and Innovation Act of 1995 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to mandate the adoption of performance standards established by nationally and internationally recognized standard-setting entities regarding determining the safety and effectiveness of class III medical devices. Prohibits requiring, as a condition for premarket approval, conformity with such standards if the applicant submits data other than that required by the standard to demonstrate a reasonable assurance of safety and effectiveness. Requires, in lieu of requiring data demonstrating the conformity of a class III device with such a standard, acceptance of an applicant's certification that the device conforms with each standard identified in the application. (Sec. 4) Modifies premarket approval application requirements, including regulating the circumstances in which submission of preclinical data and information may be required. Requires acceptance of retrospective or historical clinical data as a control or for use in determining whether there is reasonable assurance of safety and effectiveness in certain circumstances. Prohibits requiring clinical trials using randomized controls for a modification to a device if specified conditions exist. Modifies requirements regarding action on premarket approval applications. Mandates elimination of premarket approval of supplements that relate to manufacturing and product changes of a device that can be demonstrated through appropriate methods to not affect safety or effectiveness adversely. (Sec. 5) Mandates exemption from requirements regarding notification preceding introduction of devices into interstate commerce concerning class I and II devices for which notification is not necessary to provide a reasonable assurance of safety and effectiveness. Prohibits requiring additional notifications for a change or modification to certain devices in specified circumstances. (Sec. 6) Modifies requirements regarding investigational device exemptions from certain requirements. (Sec. 7) Establishes the Food and Drug Policy and Performance Review Panel.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 31 October 1995

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 31 October 1995

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 31 October 1995

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.