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Guidance Issuing OfficeCenter for Devices and Radiological Health
FDA is issuing this guidance to announce that both the list of devices subject to medical device tracking requirements, and the list of medical devices released from tracking requirements, have been updated. This updated guidance identifies all affected devices (those tracked and those released from tracking) in table format. The table includes two fields to describe each device: (1) product code (procode) and (2) the standardized procode definition (product code – preferred term). These two descriptive fields are intended to provide clarity about which devices are tracked. The product code and preferred name are generally found in the approval or clearance letter issued by CDRH.
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.