Certain Device Software Modifications Allowed Without Filing New 510(k)s

August 12, 2016 at 3:52 PM
FDA in a new draft guidance for the first time addresses when a device manufacturer can make software modifications to improve cybersecurity or restore a device to recently cleared specifications without having to submit a new 510(k). The draft guidance comes along with a broader draft guidance addressing when a manufacturer may change a device without having to file a new 510(k) premarket notification or documentation under Quality System regulations. Changes to strengthen software cybersecurity are “not likely to require...

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