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GUIDANCE DOCUMENT

The Abbreviated 510(k) Program Guidance for Industry and Food and Drug Administration Staff September 2019

Final
Docket Number:
FDA-2019-D-4015
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

This guidance provides recommendations on an optional approach that may be used to demonstrate substantial equivalence in premarket notifications (510(k)s). The Abbreviated 510(k) Program uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA's premarket review of 510(k) submissions. The alternative approach described in this guidance document is intended to facilitate 510(k) submission preparation by manufacturers and review by FDA. FDA believes this voluntary program may conserve industry and Agency resources, while still protecting the public health, and not altering the statutory criteria for substantial equivalence.

For the current edition of the FDA-recognized standard(s), see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance document 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."


Submit Comments

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:

Dockets Management
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-4015.