Freedom of Information Act (FOIA) & FDA Device Information Access
The Freedom of Information Act (FOIA) is a powerful U.S federal law that allows the public to request access to records from any U.S. federal agency including the U.S. Food and Drug Administration (FDA). It promotes transparency by enabling individuals, researchers, and organisations to learn how agencies operate and make decisions.
However, FOIA has limitations when it comes to confidentiality. Medical device 510k clearance documents of predicate device manufactures can be accessed partially through this method
Freedom of Information Act is strictly for retrieving already-processed or cleared documents, not for regulatory submissions
Alternatives to FOIA for FDA Device Information
Before submitting a FOIA request, we recommend using the FDA’s public databases and tools that already provide access to cleared device information. Refer reading room for more search. Access official 510(k) summaries, PMA documents, De Novo decisions, and labeling information without filing a Freedom of Information Act request. Search for cleared 510(k)s using product codes, applicant names, or submission numbers.
The Freedom of Information Act (FOIA) can be a strategic tool for new 510(k) applicants to gain insight into previously cleared devices. Here’s how it helps:
- Device descriptions Indications for use Testing summaries Labelling .
- Identify the most suitable predicate device(s). See how others demonstrated substantial equivalence. Avoid weak or incomplete predicate argument
- What testing was accepted, What clinical or bench data was submitted, Which labeling or claims were approved. This can significantly strengthen your own 510(k) strategy.
Content owner: Ms. Amrutha Rai, Team Lead, 510k Compliance