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Hi all, its been a while since I've posted. Lots of alligators.
Lets say there are two companies. Company A is foreign, and registered with the FDA as a device manufacturer. Company B is a U.S. company, but is a wholly owned subsidiary of company A.
Company B writes executable software for company A, develops hardware designs, develops new product prototypes for company A, and assists company A with clinical testing of the new prototypes, maybe even ghost authoring the 510K submissions.
Company B has no established QMS and is not registered with the FDA. There are no products on the market bearing company B's name and company A "owns" all specifications. Company A "verifies and validates" all designs, but they do not have in house expertise to fully understand how the product works. All marketed products bear company A's name.
This is a beautiful thing for company A, they think, because company B has little overhead and focuses exclusively on engineering tasks. Plus, any FDA inspections are limited to company A due to the fact they are foreign (and company B is "hidden").
So the question is - is this compliant? Does being a subsidiary fully absolve company B from complying with 21 CFR 820?
Lets say there are two companies. Company A is foreign, and registered with the FDA as a device manufacturer. Company B is a U.S. company, but is a wholly owned subsidiary of company A.
Company B writes executable software for company A, develops hardware designs, develops new product prototypes for company A, and assists company A with clinical testing of the new prototypes, maybe even ghost authoring the 510K submissions.
Company B has no established QMS and is not registered with the FDA. There are no products on the market bearing company B's name and company A "owns" all specifications. Company A "verifies and validates" all designs, but they do not have in house expertise to fully understand how the product works. All marketed products bear company A's name.
This is a beautiful thing for company A, they think, because company B has little overhead and focuses exclusively on engineering tasks. Plus, any FDA inspections are limited to company A due to the fact they are foreign (and company B is "hidden").
So the question is - is this compliant? Does being a subsidiary fully absolve company B from complying with 21 CFR 820?
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