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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
The main focus of this document is to provide guidance on how to format an original submission for a Traditional or Abbreviated premarket notification (510(k)) submission. This guidance document provides only a general framework for the format and content of a Traditional or Abbreviated 510(k). It does not describe our recommendations for any specific device types, Special 510(k)s, or other premarket submission types, such as premarket approval applications (PMAs), Humanitarian Device Exemption (HDE) applications, De Novo requests, or investigational device exemption (IDE) applications.
FDA believes the recommendations in this guidance document for a Traditional or Abbreviated 510(k) will conserve FDA and industry resources and facilitate timely review. This guidance document only supplements other FDA guidances on the 510(k) program and specific device types. It is not a replacement for those documents.
For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices" and "Standards Development and the Use of Standards in Regulatory Submissions Reviewed in CBER."
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-2019-D-4014.