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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance was updated on June 14, 2019 to remove product codes previously inadvertently included, which were already exempt from premarket notification requirements.
This guidance describes the Food and Drug Administration’s (FDA’s) intent to exempt certain unclassified medical devices from premarket notification requirements. FDA believes devices identified in Section IV of this guidance document are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness. Until the publication of a final rule exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.
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-2014-D-0967.