Revamped FDA Draft Guidance Updates Recommendations for Addressing Device Cybersecurity in Premarket Submissions

Dennis Tosh
April 12, 2022 at 01:01 PM EST
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The FDA has issued important updated draft guidance on addressing medical device cybersecurity issues in premarket submissions to the agency. The new draft guidance document, which supplants an October 2018 draft guidance, stresses the importance of mitigating emerging cybersecurity risks throughout a device’s useful life. It also expands the scope of the agency’s recommendat... Read More

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