CDRH unveils new guidance on Pre-Determined Change Control Plans for medical devices

By Laura DiAngelo, MPH

Over a year since its initial draft guidance document on the use of Pre-Determined Change Control Plans (PCCPs) for medical devices that leverage machine learning, allowing sponsors to pre-specific certain post-authorization modifications, the agency has issued a new draft guidance on the use of PCCPs for all medical devices.

Fill out the form to read the full article.