Re: Differences: ISO 13485 vs. FDA QSR (820) - Includes Spreadsheets
Hi. I was a level II certified medical device investigator for the FDA for over 21 years and am now working as an independent contract international medical device consultant.
I want to comment about the types of medical device products you have to manufacture in order to comply with FDA laws and regulations.
FDA is only concerned with finished products (and certain components/accessories- see below for details).
Unless the circuit boards can function and be sold by themselves as a component/ accessory to finished medical devices (which I know they aren't, because they are a sub-assembly in-process product used by another company to manufacture finished devices), you have to register with the FDA and follow applicable FDA laws and requirements (depending upon product classification) and be periodically audited/inspected by the FDA.
However, since these products are indeed in-process products, you are under the light of the finished product manufacturer not the FDA. This firm will require you to follow their specifications and to advise them of any changes you make to the product, components, suppliers, etc. (usually spelled out under a contract) and may even periodically audit your firm. What the other firm is doing is actually practicing purchasing control operations under 21 CFR 820.50.
Here is some guidance to aid you.
FDA defines a medical device (under the FD&C Act § 201(h)) as:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar or related article, including any component, part, or accessory which is:
(1) Recognized in the Official National Formulary, or the U.S. Pharmacopoeia, or any supplement to them,
(2) Intended for use in diagnoses of disease or other conditions, or used in the cure, mitigation, treatment, or prevention of disease in man or other animal, or
(3) Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary purpose through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Additionally, under 21 CFR 820.3 (l), a finished medical device is any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
Remember, if you make components/ accessories which are ready to be used for any intended health related purpose and are packaged or labeled for commercial distribution for such health-related purpose, then you are a finished device manufacturer and have to register and follow applicable FDA laws and regulations. (In this case, the circuit boards are not components/ accessories, but are in-process sub-assemblies.)