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# Industry Concerns with Predicate Device Guide
- URL: https://www.fdaweb.com/industry-concerns-with-predicate-device-guide/
- Published: 2023-12-06T12:00:00.000Z
- Updated: 2026-09-14T14:17:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155937

Three medical device industry stakeholders are raising multiple concerns about an FDA draft guidance on best practices for selecting a predicate device to support a 510(k) submission. The Medical Device Manufacturers Association (MDMA) [says](https://www.regulations.gov/comment/FDA-2023-D-3134-0038?ref=fdaweb.com) the draft appears to reflect an evolution from the agency’s approach to the 510(k) program announced in 2018\. “However,” it adds, “MDMA remains concerned that the draft guidance continues to signal FDA’s intent to impose additional requirements in the context of the 510(k) program that go beyond the substantial equivalence framework established by Congress in the Federal Food, Drug, and Cosmetic Act.”

The letter says there are recommendations in the draft concerning the selection of a predicate device that are inconsistent with the agency’s statutory authority and are otherwise inconsistent with the regulatory framework.

In its [response](https://www.regulations.gov/comment/FDA-2023-D-3134-0039?ref=fdaweb.com), AdvaMed says it is concerned that the draft contains recommendations that appear to be inconsistent with statute, regulation, and existing guidance; present practical challenges for implementation, and may not fully achieve the agency’s goal in any case. “It also proposes new recommendations for 510(k) submission and 510(k) summary content that appear inconsistent with statute and regulations and would not adhere to the least burdensome principle” it says. “While guidance documents and the recommendations they contain are not binding, it is nevertheless essential that guidance recommendations are aligned with statute and regulations.”

The Cook Group [recommends](https://www.regulations.gov/comment/FDA-2023-D-3134-0033?ref=fdaweb.com) that FDA remove several recommendations and sections from the draft.