FDA will look to update the 510(k) database

After 31 years of an FDA policy to not change the 510(k) database to indicate a change in the ownership, it appears that the FDA is finally going to issue a proposal regulation that would allow them to update this database. This is a major change in the FDA’s policy. With approximately 190,000 approved 510(k)s applications, the FDA is starting to see a large number of purchasing and transfers between companies and individuals of these 510(k)s. Many companies have learned that there is great value in these applications and that making the transfer make sense. But, making sure that the transfer is done properly is imperative to assure that it does not cause future problems, since the FDA database of owners is not updated.

The FDA has updated its computer network for registration and device listing allowing them to check all imported shipments. With a 510(k) database that does not match the new owner to the device is causing a lot of problems that requires a lot of time and efforts to straighten out. (see mdi Insight report “The 510(k) - an asset that can be sold and transferred”,
http://www.mdiconsultants.com/Section_NI/Insights/InsightsV8_is3.htm ).

It makes sense that the FDA would look into this finally. When it will be finally published has not been determined.

Be on the lookout for this regulation and make sure you make your comments. If you would like to discuss the potential problem concerning this change email mdi at info@mdiconsultants.com  and reference 510(k) database change.