If you’re looking to obtain a 510(k) submission through a Freedom of Information Act (FOIA) request, be prepared for a long and complex process. This guide breaks down everything you need to know before submitting a request—including costs, processing times, and common pitfalls.
1. How Long Does It Take to Get a 510(k) Through FOIA?
- Standard Processing Time: 18–24 months.
- If Previously Released: 3–6 months (but there’s no way to check in advance).
- Additional Delays: If the 510(k) is less than 10 years old, the FDA must notify the manufacturer and conduct multiple review rounds.
- Current FDA Estimate: Due to backlog, even simple requests may take 6–8 months before processing even begins.
2. How Much Does It Cost?
- No Pre-Request Pricing Info: The FDA won’t provide an upfront estimate.
- Initial Cost Estimate: Based on the estimated number of pages (but this can change).
- Final Cost Estimate: If the total number of pages is much higher than expected, the FDA will contact you with an update.
- Over the fee you stated at the time of the request? The FDA will notify you before proceeding.
- Billing Policy: Fees are based on redaction time, not page count, so heavily redacted documents cost the same as full documents.
Important: If you don’t respond to the FDA cost estimate within 30 business days, your request will be closed.
3. How Much Will Be Redacted?
Expect HEAVY REDACTIONS on:
- Testing & technical data
- Lab reports
- Manufacturing/vendor details
- Deficiency discussions
- Internal FDA communications
- Software & risk analysis
- Specifications & SOPs
- Unpublished studies & draft manuals
Even if most of the document is blacked out, you still pay the full review cost.
4. What Can You Request?
You can file a FOIA request for:
- 510(k) Summary (already public on FDA’s database)
- Full 510(k) Submission (heavily redacted)
- Related FDA Communications (limited access)
- List of 510(k)s from a manufacturer (cheaper and faster than full filings)
5. Can I Expedite My Request?
👉 No. The only exception is a public health emergency, and even then, the FDA rarely grants expedited processing for 510(k)s.
6. Can I Request Just Certain Parts of a 510(k) to Save Time or Money?
👉 Yes, but it won’t guarantee a faster response or lower cost. Fees are based on review time, so narrowing the request may not reduce your expense.
7. Can I Get an Unredacted Copy If I Work for the Manufacturer?
👉 Maybe. If you are the original 510(k) applicant, you might receive fewer redactions, but you’ll need to provide proof of authorization.
8. What Happens If I Don’t Respond to FDA’s Cost Estimate?
👉 Your request is automatically canceled after 30 business days. You’ll have to start over with a new FOIA request.
9. What Format Will I Receive the Document In?
👉 PDF via email, unless you request otherwise. Printed copies may be available for an additional fee.
Alternative Sources for 510(k) Documents
Instead of waiting 18+ months, consider these options:
- FDA’s Public 510(k) Database
- Find and request 510Ks from the FDA FOIA Log
- Use our FAST TRACK Requesting service
- Third-Party FOIA Document Providers – Some services (FOIA Document Source (hey! that's us!) and FOI Services) may already have the document available for purchase.
Final Thoughts
Requesting a 510(k) through FOIA is generally a slow and expensive process. If you decide to proceed, be prepared for long wait times, high costs, and significant redactions.
Instead of navigating the process alone, let FOIA Document Source manage the entire process for you. With expert handling, faster tracking, and experience with FDA requests, FOIA Document Source ensures you get the documents you need with less hassle. Make a Custom Request today to get started!