We can help with US FDA 510(k) submissions
To ensure a successful 510(k) submission, we take a two-step approach. Over the years, we have found this approach is cost-effective for our clients, and it dramatically reduces the probability of failure to receive FDA clearance of a 510(k) submission.
Pre 510(k) submission gap analysis and requirements evaluation
- The proposed intended use and design of your device help us determine the proper FDA product code and regulation number, which may point to device-specific guidance documents or required standards.
- We evaluate similar devices that already have FDA 510(k) clearance to determine whether any are suitable for use to determine substantial equivalence for your device. These are referred to as predicate devices.
- We provide a product-specific list of documents and information needed for the 510(k) submission.
- An assigned U.S. regulatory consultant will review the information to determine its suitability for the 510(k) submission.
After evaluating this documentation, we prepare a detailed gap analysis report identifying incomplete or missing information required for a complete 510(k) submission.
Dossier compilation and FDA 510(k) submission
- Prepare a technical comparison of your medical device to the predicate device(s).
- Prepare all 21 sections of the FDA 510(k) application.
- Submit the hard copy and eCopy of the 510(k) to the CDRH division within the FDA and be the correspondent for further communications with the FDA.
- Coordinate payment of FDA 510(k) submission fees on your behalf.
- Immediately communicate with you regarding all information received from the FDA following the 510(k) submission, and assist in addressing their requests for additional information, if applicable.
