Should the FDA Create a Cybersecurity Measuring Stick?

Jun 13

Agency Gets Suggestions for ‘Software as a Medical Device’ Precertification Program

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.

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

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