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# Comments Sought on 510(k) Cover Sheet
- URL: https://www.fdaweb.com/comments-sought-on-510-k-cover-sheet/
- Published: 2017-03-17T12:00:00.000Z
- Updated: 2026-09-14T22:12:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138232

*Federal Register* Notice: FDA is seeking comments on an information collection reinstatement for “Premarket Notification—21 CFR Part 807, Subpart E. The information collection involves Form FDA 3514, a summary cover sheet form, that is intended to assist respondents in categorizing administrative 510(k) information for submission to FDA. This form also assists respondents in categorizing information for other FDA medical device programs such as PMAs, investigational device exemptions, and HDEs. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-03-17/pdf/2017-05300.pdf?ref=fdaweb.com).