FDA’s Guidance on 510(k) Submission for a Software Change to an Existing Medical Device
The US FDA has published a guidance document that will help the industry and the Health Agency (HA) staff determine when a software change to a medical device requires a manufacturer to submit and obtain the FDA clearance of a new premarket notification (510(k)). This guidance intends to enhance the predictability, consistency, and transparency of the “when to submit” decision-making process by providing a least burdensome approach and describing the Regulatory framework, policies and practices underlying such a decision, specifically related to software changes.