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I am trying to collect a DHR and DMR for a company I just joined.
they essentially are taking a device that is commercially made for another use (non regulated) and are tying it into a 510k device ( device A, software, sample receptacle). My question is will I need to get an establishment ID # for the manufacturer of Device A.
the device is being screened 100% upon receipt at our facility.
I am not sure if the manufacturer of Device A has an agreement or is aware of our use as a medical device they are not ISO nor obviously a medical manufacturer establishment or signed up on the FDA website.
Do I need to sign them up even though we are the "Labeled" manufacturer of the final medical device?
I know its kinda convoluted but feel free to ask me questions.
they essentially are taking a device that is commercially made for another use (non regulated) and are tying it into a 510k device ( device A, software, sample receptacle). My question is will I need to get an establishment ID # for the manufacturer of Device A.
the device is being screened 100% upon receipt at our facility.
I am not sure if the manufacturer of Device A has an agreement or is aware of our use as a medical device they are not ISO nor obviously a medical manufacturer establishment or signed up on the FDA website.
Do I need to sign them up even though we are the "Labeled" manufacturer of the final medical device?
I know its kinda convoluted but feel free to ask me questions.