FDA Draft Guidance on software changes: tips on how to be compliant with regulations
FDA has published a new draft guidance regarding software changes into an existing device. This document is the result of Agency decision to separate software changes regulations from other devices.
This guidance shows FDA commitment in acquiring better awareness on issues related to software products.
This document provides details regarding the regulatory requirements which will have been satisfied. The aim of this guidance is both to support manufacturers when they make a software change and give advice on how to justify the change properly.