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# AdvaMed Caution on FDA Digital Action Plan
- URL: https://www.fdaweb.com/advamed-caution-on-fda-digital-action-plan/
- Published: 2017-09-05T12:00:00.000Z
- Updated: 2026-09-14T22:46:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139551

AdvaMed says it does not believe FDA should issue a final guidance based directly on an International Medical Device Regulators Forum (IMDRF) proposed document on software as a medical device. “The IMDRF document is grounded on a classification scheme that does not align with FDA’s statutory framework and, therefore, has the significant potential to bring confusion, rather than clarity, to this burgeoning space, which we understand is not the agency’s intent,” AdvaMed says in a comment [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-N-4301-0007&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) on the agency’s Digital Health Innovation Action Plan. “If the concepts in the IMDRF document are to be incorporated into FDA guidance, an FDA-specific guidance should be issued as draft, stakeholder comments considered, and finalized in full accordance with the procedures outlined in” regulations.

Despite that caution, the association says it commends FDA for the initiative described in its recent Digital Health Innovation Action Plan and believes it is appropriate for the agency to establish a new regulatory approach for medical device software. In its comment letter, the trade association says it also believes that the proposed software precertification program that is part of the plan has the potential to reduce pre- and post-market burdens for both software developers and FDA, and enable streamlined changes and modifications to software.