FDA released their CDRH Proposed Guidance Updates that includes a significant amount of “software related” guidance in FY 2021. There are four separate guidance documents listed for publication in FY 2021. IMO that is a fairly large commitment from the agency and I will look forward to reading about the agency’s “current thinking” on these very important topics.
The following software related guidance items are on CDRH’s A-list:
- FDA intends to publish Final Guidance for Clinical Decision Support Software
- FDA intends to publish Draft Guidance for Computer Software Assurance for Manufacturing and Quality System Software
- FDA intends to publish Draft Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- FDA intends to publish Draft Guidance for Content of Premarket Submissions for Software Contained in Medical Devices
The A-list: A list of prioritized device guidance documents the FDA intends to publish during FY2021.
View the proposed list from FDA here: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2021-fy-2021?utm_medium=email&utm_source=govdelivery