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GUIDANCE DOCUMENT

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

Download the Final Guidance Document
Final
Docket Number:
FDA-2018-D-3304
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

This guidance provides the Food and Drug Administration's (FDA) current thinking on premarket notifications (510(k)s) appropriate for review as a Special 510(k). The intent of this guidance is to describe an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE). This guidance clarifies the types of technological changes appropriate for review as Special 510(k)s. Specifically, within the scope of appropriate changes, we are including certain design and labeling changes, including changes to the indications for use, by focusing on whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format.

The Special 510(k) Program is consistent with FDA's statutory mission to protect and promote human health and FDA's commitment to helping patients gain timely access to new medical devices that are high quality, safe and effective by using efficient review practices consistent with least burdensome principles. This guidance, provides consistency, clarity, and transparency to industry to describe when a Special 510(k) is appropriate. This guidance supersedes the Special 510(k) policy in the "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database Web site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. For more information regarding use of consensus standards in regulatory submissions, please refer to 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 Submission Reviewed in CBER.

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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-2018-D-3304.

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