Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions Guidance for Industry and FDA Staff April 2008
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance document is intended to assist industry in preparing an Abbreviated premarket notification submission (510(k)) to establish that the device is substantially equivalent to a predicate hemodialysis blood tubing set for use as the extracorporeal blood circuit during hemodialysis treatment. This guidance document identifies specific recommendations for the content and format of an Abbreviated 510(k) submission for hemodialysis blood tubing sets. This version of the guidance is intended to clarify the April 14, 2008, guidance of the same title and is consistent with FDA’s original approach to premarket notification (510(k)) submissions.
The Least Burdensome Approach
The issues identified in this guidance document represent those that we believe need to be addressed before your device can be marketed. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to follow the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. If, however, you believe that there is a less burdensome way to address the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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:
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.