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# Clarify What SiMD is Included in SaMD Plan: AdvaMed
- URL: https://www.fdaweb.com/clarify-what-simd-is-included-in-samd-plan-advamed/
- Published: 2021-04-20T12:00:00.000Z
- Updated: 2026-09-14T16:55:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149148

AdvaMed says an FDA action plan on artificial intelligence/machine learning-based software as a medical device (SaMD) should clarify which aspects of the plan also apply to software in a medical device (SiMD). “We generally believe FDA should apply the same policies to SiMD as it does for SaMD products and that future guidances and regulations in this area should incorporate both SaMD and SiMD,” the trade group says in a 4/13 [letter](https://downloads.regulations.gov/FDA-2019-N-1185-0135/attachment%5F1.pdf?ref=fdaweb.com). “SiMDs are common medical device components and their development, premarket, and postmarket considerations are nearly the same. Different policies between these types of software are not necessary.”

The letter also includes a chart of page-by-page technical comments.