FDA Modifying Medical Device Classifications

FDA Modifying Medical Device Classifications

The FDA is officially modifying medical device classifications for some software functions.

On April 19, 2021, the agency published a “final” rule that updates eight classification regulations by amending these regulations to exclude software functions that no longer fall within the device definition under 201(h) of the FD&C Act.

With this final rule, FDA is amending the “identification” description of eight classification regulations so that the regulations no longer include software functions that the Cures Act excluded from the device definition in the FD&C Act.

In other words, in this action, FDA is amending eight classification regulations so that the regulations conform to the medical software provisions of the Cures Act and reflect FDA’s current statutory authority.

That FDA is modifying medical device classifications is not actually new news, it is a final formulation of policy that had previously been provided in already published FDA guidance. So, now that the regulation is published, the classifications become legal and are no longer just the “current thinking” as provided by guidance.

See related post:  Medical Device Section 21st Century Cures Act

About the author

John is a 25 year FDA veteran. John served as a regulatory and compliance expert for FDA regulated computers and software. Practice (focus) areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.

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