I agree with ial4 and appreciate sharing the guidance for market approval/submission when there is a change in a medical device. Depending on the risk from the change being made and the classification of the device determines whether a interim notification, a new 510(k) submission, or premarket approval (PMA) will be necessary. Either way, the FDA needs to be notified on the change. The risk assessment and the product change request being made will determine the regulatory submission lead time. So if changing the product’s material will be cost effective to the legal manufacturer, but will increase the risk, decreasing the device’s safety, then a new submission will need to be made to the FDA. In Guiding Principles (Section IV. Part 7) it discusses a significant change of a product from its preamendment device. In my opinion, the section highlights if the change is significant enough, it could potentially change the product’s classification.

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514771.pdf