U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Intravascular Administration Sets Premarket Notification Submissions [510(k)]
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
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

Submit Comments Online

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.

Back to Top