Does 21 CFR 820.80 (b) require a Supplier to have Receiving Inspection?

M

MJW66

#11
That was a great thought provoking response. Thank you for taking the time to articulate it. Yes, you are correct, they would NOT be considered a Contract Manufacturer and thus, not directly regulated by 21CFR820. I was using the term in the business sense and it probably confused my situation. This is why I love this forum!

Just so I have this correct..... a component manufacturer that sells to end users (not the OEM, i.e. replacement components) IS required to register and list AND is regulated by 21CFR820. But, a component manufacturer that sells to the OEM or manufactures to another companies design and only sells to that company IS NOT required to register and list and IS NOT regulated by 21CFR820. They would be obligated by the Purchasing Controls 21CFR820.50 enforced either by the OEM or the other company that owns the design for which they are manufacturing. Is this correct?
 
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M

MIREGMGR

#12
a component manufacturer that sells to end users (not the OEM, i.e. replacement components)
An object maker that sells to end users must determine if what they are selling is a finished medical device (or an accessory).

If it's a finished medical device (or an accessory), then they are a Manufacturer (either Contract or Responsible) and they are subject to 21CFR820.

If it's not a finished medical device (or an accessory), then they are a component maker per 21CFR807.65.

A component maker that sells directly to medical device end users is still a component maker. The fact of selling components as replacement parts directly to end users does not change a component maker into a Manufacturer. If however the "components" themselves meet the definition of finished medical devices, or accessories, then they're regulated as finished devices, not as components.
 
M

MJW66

#13
That is interesting, but I see a "regulatory gap." For instance, say a component manufacturer (not an accessory or finished device) sells a hospital a substandard replacement component to a finished device. Who is conducting the oversight of the component manufacturer if they are not regulated by 21CFR820? Certainly not the hospital. Let's say it is a wheel manufacturer that makes wheels for gurneys, hospital beds, etc. and they are direct marketing to hospitals, not the OEM's. Worse case scenario is that the wheels are extremely defective and cause beds and gurneys to collapse. Of course if this would happen, the FDA would most likely then step in, but I'm talking about a proactive approach. As a replacement component manufacturer selling directly to end users, they DO NEED to register and list, but you are stating that they are not regulated by 21CFR820. I hope I have that correct because I don't want to misinterpret what you have stated and I know that you are not directly stating it, but it is your interpretation of the guidelines. If this is correct, is this not a gap from a regulatory QMS standpoint? That is, 21CFR820 is not required or enforced for the replacement component manufacturer.
 
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M

MIREGMGR

#14
For instance, say a component manufacturer (not an accessory or finished device) sells a hospital a substandard replacement component to a finished device. Who is conducting the oversight of the component manufacturer if they are not regulated by 21CFR820? Certainly not the hospital. Let's say it is a wheel manufacturer that makes wheels for gurneys, hospital beds, etc. and they are direct marketing to hospitals, not the OEM's. Worse case scenario is that the wheels are extremely defective and cause beds and gurneys to collapse. As a replacement component manufacturer selling directly to end users, they DO NEED to register and list, but you are stating that they are not regulated by 21CFR820.
In your scenario, if the product of the "component manufacturer" is packaged/labeled to communicate that it has a medical device related use, it is an accessory.

If the product is sold bulk with no guidance or acknowledgement by the seller that the product has a medical device related use, that's a gray area. My take would be that unless the maker of the target medical device has specified to buy the subject product as a replacement component, FDA would regard the end user as responsible for the installation of the replacement components. I know of no history in which FDA has attempted to regulate a maker/seller of generic industrial components as a medical device maker just because a user of devices buys their products as replacement parts, as long as the generic-component maker hasn't communicated that their products are specifically suitable for a use related to medical devices.

That's the limit of my knowledge on this. If you need a formal determination of a product's status, start by talking to FDA DSMICA.
 
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