This points-to-consider document supplements existing FDA guidance for premarket submission of in vitro diagnostic devices for approval or clearance. The information requested is intended to be comprehensive but may not be all inclusive. The emphasis is on FDA's particular concerns in the review of cytology devices for gynecologic specimens.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.