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# AdvaMed Comments on Uncertainty Guidance
- URL: https://www.fdaweb.com/advamed-comments-on-uncertainty-guidance/
- Published: 2018-11-21T12:00:00.000Z
- Updated: 2026-09-15T00:46:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142873

AdvaMed has submitted its comments to FDA on the agency’s draft guidance on consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals. The association provided FDA specific line-by-line [comments](https://www.regulations.gov/document?D=FDA-2018-D-3130-0004&ref=fdaweb.com).