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US regulators are proposing updates to a guidance document they finalized in February for devices used to clear arteries of plaque. The updated language specifically addresses software interoperability, pyrogenicity and certain performance-testing requirements.
US House Panel Votes For 5.8% Cut In FDA Device Center’s 2021 Budget Authority, Seeks COVID-19 Review
While the House Appropriations Committee is calling for a 5.8% cut in the FDA device center’s budget authority, it nevertheless gives a boost to the agency’s medical device safety and cybersecurity functions.