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GUIDANCE DOCUMENT

Intravascular Administration Sets Premarket Notification Submissions [510(k)] Guidance for Industry and FDA Staff July 2008

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)s) submissions for intravascular (IV) administration sets and accessories. This revision of the document issued in 2005 updates the FDA-recognized standards and clarifies our recommendations for microbial ingress testing. IV administration sets and accessories include:

  • extension sets 
  • IV stopcocks and manifolds
  • in-line filters
  • flow regulators
  • fluid delivery tubing
  • vial adapters
  • IV transfer sets
  • subcutaneous administration sets
  • blood administration sets
  • transfusion filters.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.