FDA Offers Flexibility For Device Makers To Meet New Cyber Mandate

By Jessica Karins / March 29, 2023 at 5:57 PM
Updated Story FDA has issued new guidance on cybersecurity information that medical device manufacturers are required to submit beginning this week as part of premarket submissions, but the agency says it won’t automatically reject marketing applications for the next six months as companies grapple with how to show their products are protected from cyberattacks. Starting in October, however, applications that omit the information may be refused. FDA offers to work with companies in the first months of...

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