Zdrowie i gospodarka · 08/08/2016

FDA Releases Draft Guidance on Submitting 510(k) for Software Changes to Existing Medical Devices

The US Food and Drug Administration (FDA) has published a draft guidance document outlining the circumstances under which a software update to a premarket-approved medical device would necessitate submitting a premarket notification (510(k)) to the FDA, aiming to clarify the agency's regulatory requirements for such changes.