Change to an FDA Cleared Device

[RamsayP]

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

Does that seem accurate? Am I missing anything you can think of?

 

[DallasThomasIQVIA]

@RamsayP that seems like a sound approach. Remember that the FDA 510(k) Clearance is focused on the end product safety and efficacy and any specific requirements around the product safety and efficacy. You will need to assess the change against the FDA's Decision Tree in the Guidance Document, When to Submit a 510K for a change to a previously cleared device. There is a decision tree in that guidance document that is periodically updated. If the decision tree shows that no 510(k) is needed you can keep that documentation on file as a Note to File / Letter to File that you can use as objective evidence for the FDA during their Quality Systems Inspection of your establishment. I have sat in FDA Inspections being the Quality Representative of the company and they have asked to follow-up on this based on the Quality Systems regulations requirements. So your Purchasing Controls / Supplier Controls for anyone physically manufacturing on your behalf should be assessed, including any impact to the product itself as part of the manufacturing / production changes. Hope that helps.

 

[Haresh]

Hi,
I have one query regarding requirement of 510k submission in following scenario:
Suppose, we have 510k for cleared class II instrument, say example Screw driver .Later on we modify this device with one new features ( for better engagement of screw) as per the customer requirement and considered as new device with assigned new part number for identification. This change may not impact on intended use , safety and performance. So, my question is that can we add this new instruments/new part number in our existing 510k or whether we require special 510k submission or can we do "note to file or letter to file. Please guide us in this scenario.

Thanks
Haresh N

 

[Ed Panek]

FDA wants to stay abreast of changes that create a new benchmark for that type of device. For example, if the FDA permits use of an older design as a predicate for a device that has since undergone numerous changes to improve safety and efficacy, the FDA is concerned about this scenario. They would request a special 510(k) to say "Hey FDA, this device (Product code) has a new performance benchmark"

 

[Haresh]

FDA wants to stay abreast of changes that create a new benchmark for that type of device. For example, if the FDA permits use of an older design as a predicate for a device that has since undergone numerous changes to improve safety and efficacy, the FDA is concerned about this scenario. They would request a special 510(k) to say "Hey FDA, this device (Product code) has a new performance benchmark"

Thanks a lot Ed Panek.