One of the common questions we face when modifying the design of a medical device is whether a new 510k is required because of the change. To answer this question we make extensive use of the FDA 510(k) Memorandum #K97-1 . This document includes a flowchart that helps developers determine if a new 510k is required or if is sufficient to document the changes in the Design History File (DHF).
Understanding this memo can provide valuable insights when developing your original 510k submission so that it cover future design modifications. Please contact us if you are developing a medical device and need support with your 510k submission strategy.
Understanding this memo can provide valuable insights when developing your original 510k submission so that it cover future design modifications. Please contact us if you are developing a medical device and need support with your 510k submission strategy.
