The FDA Issued the Final Rule: Medical Device Classification Regulations to Conform to Medical Software Provisions in 21st Century Cures Act

If your email program has trouble displaying this email, view as a webpage. The FDA issues final rule amending medical device classification regulations, excluding non-device software functions Today, the U.S. Food and Drug Administration (FDA) issued the final rule: Medical Device Classification Regulations to Conform to Medical Software Provisions in 21st Century Cures Act. The final rule: Amends eight classification regulations so the regulations conform to the medical software provisions of the Cures Act and reflect the FDA's current statutory authority. Amends the "identification" description of eight classification regulations so the regulations no longer include software functions that the Cures Act excluded from the device definition. Read the Final Rule Questions? If you have questions, contact the Division of Industry and Consumer Education.

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