MedTech Dive September 27, 2023
Congress granted the agency authority to deny premarket submissions that lack cybersecurity information, starting in October.
Dive Brief:
- The Food and Drug Administration has finalized guidance intended to help device developers comply with recently enacted cybersecurity obligations for premarket submissions.
- In the guidance, the FDA outlines how to use a secure product development framework to manage cybersecurity risks, explaining how the model applies to risk management, security architecture and cybersecurity testing.
- The FDA, which could start refusing filings that lack cybersecurity information on Oct. 1, finalized the guidance after reviewing more than 1,800 comments on a draft it published last year. Based on the feedback, the FDA clarified required documents and interoperability considerations.
Dive Insight:
Late last year,...
Today's Sponsors
Today's Sponsor