FDA Reacts to Critique of Medical Device Security Strategy

November 7, 2018 Mayuri Kumar

The Food and Drug Administration's procedures for handling cybersecurity concerns in medical devices once they are on the market are deficient, according to a new federal watchdog agency report. But since the audit was conducted, the FDA has been aggressively ramping up its activities around medical device cybersecurity, including addressing many of the issues spotlighted in the report.

The Department of Health and Human Services' Office of Inspector General's report says the agency found FDA's policies and procedures insufficient for handling postmarket medical device cybersecurity events.

David Finn’s comments are featured in this article.

 

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