Namely, that the FDA doesn't certify devices in any use of the term, and that the cybersecurity guidelines are a draft guidance for... >
Although this is interesting, it over-inflates the reach of DMCA and gets facts wrong about device clearances.https://twitter.com/doctorow/status/724663627072983040 …
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> what materials should be included with a premarket submission.
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"The FDA typically will not need to review or approve medical device software changes made solely to strengthen cybersecurity."
End of conversation
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