To amend the Federal Food, Drug, and Cosmetic Act with respect to valid scientific evidence.

Summary

This bill amends the Federal Food, Drug, and Cosmetic Act to define “valid scientific evidence” to include well-documented case histories or studies published in peer-reviewed journals for purposes of the Food and Drug Administration (FDA) determining the effectiveness of a medical device without clinical investigation. Under specified conditions, the FDA may request the data underlying a study that is offered as valid scientific evidence.

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 House (text)

  Introduced in House · EN · 19 May 2015

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 19 May 2015

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 19 May 2015

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.