Medical Device Accessories - Describing Accessories and Classification Pathways Guidance for Industry and FDA Staff December 2017
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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
FDA developed this document to provide guidance to industry and FDA staff about the regulation of accessories to medical devices. This guidance is intended to describe FDA’s policy concerning the classification of accessories and to discuss the application of this policy to devices that are commonly used as accessories to other medical devices. In addition, this guidance explains what devices FDA generally considers an “accessory” and describes the processes under Section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow requests for risk- and regulatory control-based classification of accessories.
The 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-2015-D-0025.