M
Re: Can FDA require us to do this?
Loosely- or un-controlled process changes on Class II devices are always problematic. It could have been worse...they could have found that the process changes amounted to potentially significant product changes for which a new 510(k) would be required to re-prove that the product still was safe and effective, and substantially equivalent to a legally marketed predicate device or otherwise entitled to marketing approval.
Presumably the inspector felt, after the initial part of your audit, that the documentation of that assurance was substantially inadequate. That's the trigger for upstream inspections... which are done not to audit the vendors, who (mostly) are not legally encompassed by FDA authority, but rather as an extension of their audit of you.
The FDA has legal authority to inspect anybody and everybody that participates in your medical device creation process, if they determine such inspections are needed. That's one of the differences between the FDA and 13485. It's related to the fact that the FDA folks have badges, and can call in the federal marshalls if they need them. But, they can't (except in extraordinary circumstances) shut down your non-registered suppliers, or apply civil penalties to them. They do have that level of authority over you, on the other hand.
I'm sure it'll get straightened out.
Loosely- or un-controlled process changes on Class II devices are always problematic. It could have been worse...they could have found that the process changes amounted to potentially significant product changes for which a new 510(k) would be required to re-prove that the product still was safe and effective, and substantially equivalent to a legally marketed predicate device or otherwise entitled to marketing approval.
Which is what I am SO UPSET AND CONFUSED about.
Current FDA policy is to rely upon the finished device manufacturer to assure that components are acceptable for use.
The FDA has legal authority to inspect anybody and everybody that participates in your medical device creation process, if they determine such inspections are needed. That's one of the differences between the FDA and 13485. It's related to the fact that the FDA folks have badges, and can call in the federal marshalls if they need them. But, they can't (except in extraordinary circumstances) shut down your non-registered suppliers, or apply civil penalties to them. They do have that level of authority over you, on the other hand.
I'm sure it'll get straightened out.