What Is an FDA CFG for medical devices?
A CFG is a snapshot of your company’s medical device compliance status in the US. It serves as proof that you meet the following requirements:
- Your US facility is FDA‑registered, and your device is FDA‑listed
- Your device has legal US marketing status via 510(k), PMA, De Novo, or pre‑1976 authorization
- You follow FDA labeling rules
- You comply with FDA quality systems (21 CFR Part 820)
- Your device is not the subject of a recall
A CFG only applies to devices legally marketed in the US. If your device is pending or unapproved, it doesn't qualify for a CFG. Instead, you’d need a COE under 801(e)(1) or 802, depending on class and export intent (e.g., if you’re exporting for non-clinical research).
How to Request a CFG from the FDA
CFGs and other export documents are obtained through FURLS CDRH Export Certification Application & Tracking System (CECATS), the agency’s online portal for export certificate requests. The process is fairly straightforward, but missing information, formatting errors, or outdated listings can delay your approval. Here’s what you need to know to submit a complete CFG application:
- Access CECATS: Log in via FDA FURLS and access the CDRH Export Certification Application and Tracking System.
- Complete all required sections and add product list: Include requester info, manufacturer/distributor details, device listing, recall history, target countries, export intent, and your certification statement.
- Submit and pay fees: If FDA issues within 20 business days, fees apply (around $175 for the first, $85 for each additional request).
- Receive your CFG: All certificate request reviews completed by the FDA will be issued electronically as downloadable PDFs. FDA will email your application's approval, and you'll have 45 days to download and print (make sure to print in color if apostille is required in your target market).
The FDA processes requests usually within 20 working days if fees are paid and there are no issues in your application file.
