1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff July 2026

Download the Final Guidance Document
Final
Docket Number:
FDA-2026-D-1877
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides the FDA’s recommendations on information to support premarket notification (510(k)) submissions for hemodialysis blood tubing sets. The recommendations are intended to promote consistency and facilitate efficient review of hemodialysis blood tubing set submissions.

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-2026-D-1877.

Back to Top