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Federal
Premarket Approvals (PMA)
U.S. Department of Health & Human Services —
Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An... -
Federal
Inspection Database
U.S. Department of Health & Human Services —
FDA is disclosing the final inspection classification for inspections related to currently marketed FDA-regulated products. The disclosure of this information is not... -
Federal
Harmful and Potentially Harmful Constituents
U.S. Department of Health & Human Services —
The FDA shall publish in a format that is understandable and not misleading to a lay person, and place on public display, a list of 93 harmful and potentially harmful... -
Federal
Pistachio Product Recalls
U.S. Department of Health & Human Services —
This list includes food subject to recall in the United States since March 2009 related to pistachios distributed by Setton Pistachio of Terra Bella, Inc. The FDA has... -
Federal
X-Ray Assembler Data
U.S. Department of Health & Human Services —
Federal regulations require that an assembler who installs one or more certified components of a diagnostic x-ray system submit a report of assembly. This database... -
Federal
IVD Home Use Lab Tests (Over The Counter) Tests
U.S. Department of Health & Human Services —
Searchable listing of Over-the-Counter tests (OTC) and collection kits that have been cleared or approved by the FDA -
Federal
522 Postmarket Surveillance Studies
U.S. Department of Health & Human Services —
The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the... -
Federal
CDRH Advisory Meeting Materials Archive
U.S. Department of Health & Human Services —
This database contains historical information about CDRH Advisory Committees and Panel meetings through 2008, including summaries and transcripts.