When Does Regulated Software Need a New 510(k)?

A ubiquitous characteristic of software is that it often undergoes numerous changes after it is first released for general use. These changes may be to fix things that were never right in the first place, or to provide new features and/or greater security. If the software is a “medical device”, or part of a medical device, or connects medical devices, then changes may come under the FDA’s regulatory processes. New Draft Guidance from FDA A recurring question for software that is a medical device and which is actively regulated is when do changes to that software require a new 510(k) if Class II or a new PMA or PMA Supplement for Class III. For class II devices this has been addressed in a recent FDA Draft Guidance Document (DGD) entitled “Deciding When to Submit a 510(k) for a Software Change to an Existing Device“. Note that when finalized Guidance Documents present FDA’s thinking on a matter without officially creating a regulation or in principle an absolute requirement that the guidance be followed. Therefore a DGD presents what the FDA is thinking it is going to be thinking, after comments are reviewed and a final guidance issued. The key rule covering change for Class II software is that a new 510(k) is required whenever there is a design change or modification that could significantly affect its safety or effectiveness. The FDA notes that no matter what you call a change (eg fix, update, tweak, patch, etc), it is still a design change. Now ...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Standards & Regulatory Source Type: blogs