June 3, 2015

Marjorie Shulman Responds to MedCon Attendees

Marjorie Shulman Responds to MedCon Attendees

Cincinnati, OH – Marjorie Shulman, Director – Premarket Notification (510k) Program, FDA presented “Improving Your Chance of 510(k) Success” at the 2015 FDA/Xavier MedCon Conference. Marjorie fielded questions from the audience following her presentation.

One particular question pertained to “add-to-file” documents sent to FDA in order to keep the FDA’s 510(k) file up to date with modifications that the manufacturer implemented but considered not significant enough to require a new 510(k). Marjorie answered the question from the podium but also indicated she would provide a more detailed response after the conference. Below is more information provided by Marjorie on this topic:

We have used two terms for information the FDA receives that is either unsolicited or does not affect the review clock.
1. If information is received during the review of a 510(k) we consider that an “amendment”. This can happen if the reviewer is working interactively with the applicant or if the information is unsolicited.
2. If information is received after a final decision we called this an “add to file”.

FDA has not advertised anything regarding add-to-files in the past because technically a company should make their own decision on whether or not to submit a new 510(k) for a change or modification. This would explain why one questioner at MedCon had never heard of “add-to-file” documents.

If we receive documents after the decision has been made, we have to accept it, so we log it in under the 510(k) number and send it to the division. If the division looks at it and it appears to be a significant change we will let the company know. If it is not a significant change, then we just add it to the file (hence the name). Again we do not actually want this type of information to come in to us. The decision to file a new 510(k) resides with the company.

Also transfer of ownership is handled through Registration and Listing. The 510(k) database has always been a snap shot in time. The 510(k) holder, device name, etc. is how it is listed in the database on the day of the final decision – and we do not change or update it. FDA does not require information to be sent-in to keep FDA up to date (like an annual report). This information should be kept in the company’s own files.

To view Marjorie’s presentation click here.