Use repackers 510(k)?

A

ascherp

#11
Sorry, I can't help you on that. I fear it is one of those things that the FDA has not spelled out, but requests anyway. Since 2012 I have accompanied seven FDA inspections of foreign firms. The investigators have requested to see such authorizations of all 510(k) owners. The reasoning is that as design owners of Class 2 devices they need to be able to control what is sold by whom and under what conditions. The authorizations need to include the requirement that the significant regulatory content of the 510(k) owner's labeling will not be modified by the relabeler (such as indications for use, warnings and contraindications, performance claims, or sterilization parameters) and that the relabeler will submit his labeling to the 510(k) owner for review and approval. In addition, if the 510(k) owner makes any significant changes to his labeling, for instance by adding a warning due to the complaints he has received, he must communicate it to the relabeler, who needs to incorporate the revision into his own labeling.

Apparently there are too many relabelers out there who make up performance claims and write up instructions for use that have nothing to do with the original content of the 510(k), compromising safety and effectiveness.
 
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Ronen E

Problem Solver
Staff member
Moderator
#12
Sorry, I can't help you on that. I fear it is one of those things that the FDA has not spelled out, but requests anyway. Since 2012 I have accompanied seven FDA inspections of foreign firms. The investigators have requested to see such authorizations of all 510(k) owners. The reasoning is that as design owners of Class 2 devices they need to be able to control what is sold by whom and under what conditions. The authorizations need to include the requirement that the significant regulatory content of the 510(k) owner's labeling will not be modified by the relabeler (such as indications for use, warnings and contraindications, performance claims, or sterilization parameters) and that the relabeler will submit his labeling to the 510(k) owner for review and approval. In addition, if the 510(k) owner makes any significant changes to his labeling, for instance by adding a warning due to the complaints he has received, he must communicate it to the relabeler, who needs to incorporate the revision into his own labeling.

Apparently there are too many relabelers out there who make up performance claims and write up instructions for use that have nothing to do with the original content of the 510(k), compromising safety and effectiveness.
Thank you.

All this is understood. I didn't suggest that anyone can market a deviating device based on an existing 510k. To put it simple, my question could be: "If the devices are identical as far as 510k contents are concerned, what does ownership [a commercial aspect that FDA doesn't formally track] have to do with regulatory compliance?"

I understand (and share) the "common sense" feel, and as I stated above I realise that this could be a FDA de-facto attitude, but I was wondering what the legal basis is. The FDA shouldn't be enforcing something that has not gone through proper authorization.
 
A

ascherp

#13
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.
 
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Ronen E

Problem Solver
Staff member
Moderator
#14
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.
 
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A

ascherp

#15
Yes, fortunately the FDA is reasonable in its interpretation and enforcement of the requirements according to the specific situation and device in question. The design control/DHF requirements didn't even exist until 1997, so an approved DMR is fine for older devices. Even now, DHF documentation for a simple device such as the one you describe would be very lean.
 
O

Oscar Wang

#16
Hi, guys:
i have a question here, transfering a 510(K) ownership means that new owner shall fully take responsibility of the design of this device. FDA will also check the DHF during the facility inspection. Do you have enough confidence to handle that?
 
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