Hi Ronen. Actually I feel they're not enforcing ownership of the 510(k) as such, but rather of design. Ownership of the DHF is transferred with the 510(k), so to speak. The FDA considers the new owner of the 510(k) to be the new owner of the DHF and of the corresponding DMR and to be responsible for any design changes. That's the aspect of transfer of ownership the FDA is interested in and can enforce, not the commercial part. They just need to know with whom that responsibility lies.
Perhaps a well-defined agreement could keep both aspects clearly separated and transfer commercial ownership while design ownership remains with the original applicant? I haven't seen that as yet, but it should be possible. If it is spelled out clearly, then this particular transfer of (commercial) ownership would definitely not be a concern of the FDA and wouldn't have any regulatory consequences. I totally agree with you on that.
Hi,
"DHF responsibility" and "DMR responsibility" are relevant only if the design evolves. Surprisingly, some cleared devices designs stay stagnant for extended periods, even 10, 20 years. In such a situation, as far as I understand, all that is required for being
fully compliant is access to the original, unchanged DMR.
I'll tell you about a real case I know. Entity AAA developed, manufactured and sold a medical widget in bulk, to other entities who integrated it in their own finished devices. AAA didn't need a
510k because the widget wasn't sold as a finished device. Entity BBB (essentially a commercial entity with no manufcaturing capabilities) then engaged AAA commercially, to place AAA's widget on the USA market as a packed, finished device. The nature of the widget is such that it can serve both as a "raw" component and as a finished device with a relatively small & simple addition at the back end of the process. AAA developed that process and provided the "finished" widget to BBB. BBB submitted and cleared the 510k under its name, but in fact AAA provided all the knowledge, and naturally gained acess to all the 510k files. BBB owned the 510k in the commercial sense (they paid for it, and it was in the contract), but the labeling showed AAA's details. That was done because AAA already had a good reputation in the market, and they were responsible for everything technical (including complaints) anyway. So far so good.
Years went by, and the entities parted for various reasons. BBB could no longer get the widget from AAA, and pretty much from anywhere, because AAA held important bits of the DMR as proprietary. Now, AAA wanted to market the widget itself, as a finished device. They had all the knowledge and there was a 510k in place. FDA didn't mind and didn't look for "permission" from BBB, because it was obvious that AAA didn't need any support from BBB for being perfectly accountable (as they have been all these years). The only problem was commercial - BBB took AAA to court for undue use of BBB's property - the 510k.