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Should the FDA Create a Cybersecurity Measuring Stick?


Application Security , Cybersecurity , Endpoint Security

Should the FDA Create a Cybersecurity Measuring Stick? Agency Gets Suggestions for 'Software as a Medical Device' Precertification Program Marianne Kolbasuk McGee (HealthInfoSec) • June 12, 2018

The Food and Drug Administration should consider some sort of measuring stick when assessing a vendor's cybersecurity culture to determine if it qualifies for the agency's proposed fast-path program for premarket approval of "software as a medical device" products, some industry stakeholders say.

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The FDA accepted comments on its "working model" for a SaMD precertification program through May 31.

The agency will review and incorporate the public feedback as it refines its plans for the proposed program.

The federal website shows that FDA has received more than 60 comments on its plans for a precertification program to fast-path certain SaMD products for...(continued)

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