Does anyone know of anywhere in the FDA's CFR or other "Guidance" documents a reference to checking for "patent infringement" during the Design Control process? Shouldn't all medical device manufacturing companies point to an SOP or somewhere in the CFR for a check of "patent infringement" during some phase of the Design Process?

As always, I am grateful for any and all response!

Best Regards!

LEE

Does anyone know of anywhere in the FDA's CFR or other "Guidance" documents a reference to checking for "patent infringement" during the Design Control process? Shouldn't all medical device manufacturing companies point to an SOP or somewhere in the CFR for a check of "patent infringement" during some phase of the Design Process?

As always, I am grateful for any and all response!

Best Regards!

LEEFDA has no requirement as far as I know, but you can certainly make it part of your procedure.

Unfortunately, Mr. Rosen is correct. The FDA has not requirement for the checking of patent infringement. Plus, you can not use them to enforce a patent when a company infringes.

It is a good idea to do a patent search. The following links help with that:

http://www.uspto.gov/patft/

http://www.freepatentsonline.com/

Patent infringement is a Department of Commerce issue, not a Department of Health and Human Services/PHS issue (i.e. not an FDA issue). However, nothing is stopping one from making this a design input requirement.