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# AdvaMed Trial Participation Snapshot Comments
- URL: https://www.fdaweb.com/advamed-trial-participation-snapshot-comments/
- Published: 2025-01-15T12:00:00.000Z
- Updated: 2026-09-14T14:51:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158491

AdvaMed recommends that FDA revise the title of CDRH’s *Device Trial Participation Snapshots* to reflect that the program intends to provide key information about clinical trials that support the agency’s approval of new medical devices. The association’s comment [letter](https://downloads.regulations.gov/FDA-2024-N-4561-0003/attachment%5F1.pdf?ref=fdaweb.com) also makes these recommendations:

- allow sponsors to review their snapshots before they are published;
- work closely with sponsors to ensure that each snapshot includes appropriate context and any information deemed pertinent for supporting informed discussion between patients and their healthcare providers;
- instead of providing a paraphrased summary of a device’s benefits and risks, link to other FDA Web pages that contain the information;
- add information about the “demographics snapshot” to the “Recently-Approved Devices” Web page;
- clarify how FDA has determined the demographic information needs of the broader public, healthcare providers, and community;
- highlight the “snapshot in time” aspect of the tool and explicitly communicate how old the data is for each device; and
- clarify the criteria FDA uses in selecting PMAs for this process.

The letter also lists 10 questions AdvaMed asks FDA about the snapshot program and process.