U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)
  1. Regulatory Information

GUIDANCE DOCUMENT

Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) Guidance for FDA Reviewers July 2001

Final

Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)

Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

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

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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010