This guidance presents an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for blood and plasma warmers used in blood establishments. The detailed requirements for premarket notifications in 21 CFR Part 807 should also be consulted.
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.