Kit Certification for 510(k)s on the CDRH website - Does anyone make these?

[Adele]

I have come across the Kit Certification for 510(k)s on the CDRH website (http://www.fda.gov/cdrh/ode/odecl874.html). Does anyone actually use this as part of their 510(k)?

Both this certification and the Convenience Kits Interim Regulatory Guidance make for interesting reading but we have never been asked for a Kit Certification (and yes, our products are on the list in the guidance document).

 

[MIREGMGR]

Regarding the OP's question, in case a 1.5-year-later answer is useful to someone:

My understanding of the FDA's expectation regarding kits is that if an Establishment is a Manufacturer; their Kit Packing activity is focused around products that they Manufacture, which are the primary elements of their kits; nothing in their kits is of a nature that might be regarded as presenting a significant risk, or is of a higher regulatory classification than their Manufactured products; and those Manufactured products are appropriately conformant, then that Kit Packing activity is regarded regulatorily as not requiring additional or special conformance efforts.

I don't know anyplace that that understanding is written down, though.

We've made a number of kits (basically, sterile equipment-cover products that are kitted with clinically useful, low-risk accessories) for over a decade without adverse attention. Our stance is per the above.