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# AdvaMed Backs 510(k) Pathway
- URL: https://www.fdaweb.com/advamed-backs-510-k-pathway/
- Published: 2019-05-15T12:00:00.000Z
- Updated: 2026-09-15T01:27:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144111

Commenting on an FDA request for comments on modernizing the 510(k) program, AdvaMed says it supports the current program, which includes the ability to use older legally marketed devices as predicates, to the extent substantial equivalence can be demonstrated. “The 510(k) program has demonstrated its effectiveness and durability over the years, and remains a critical component of the agency’s ‘gold standard’ for safety and effectiveness,” the [comment letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2018-N-4751-0043&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says.

AdvaMed says FDA has made many important process improvements in the 510(k) program since its 1976 inception and it supports the current review of the program and the objective of implementing continuous improvement. It cautions that the agency should have objective evidence that a fundamental change to the 510(k) process, such as limiting the use of older devices as predicates, would improve the program before seeking new legislative authority.

“We do not believe that such authority is warranted,” it says, “as FDA has current authorities to address safety concerns with respect to specific types of devices. Current authority allows FDA to up-classify medical devices, effectively removing them as predicates. FDA also has authority to impose special controls for all moderate risk devices where deemed appropriate, as well as to issue guidance documents with new or updated recommendations. FDA also has authority to ban a device, which removes it from the market and makes it ineligible to be used as a predicate.”

AdvaMed says it believes that the current 510(k) process, including the ability to use older devices as predicates, is appropriate and does not create hurdles to the evolution of technology.