Can someone double check my process understanding please? If I have a Class 2 cleared medical device and want to make a change to manufacturer (I am spec developer, it is made by contract manufacturer), this is what I am thinking:
- I would need to assess the change being made for unintended consequences. E.g. does changing manufacturer change equipment, process, materials, sterilization, etc.
- If it does, that could trigger a new 510(k), so I would then want to get my new performance testing / validations ready prior to submission. Go through design control process.
- If it does not trigger a new 510(k), minimally I need to do a local change control, document my rationale for why no 510(k) is needed, have contract manufacturer update establishment reg, update procedures if needed and do training, update DMR, maybe update labeling addresses