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GUIDANCE DOCUMENT

The Special 510(k) Program Guidance for Industry and Food and Drug Administration Staff September 2018

Draft

Not for implementation. Contains non-binding recommendations.

The Special 510(k) Program

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance provides the Food and Drug Administration’s (FDA) current thinking on premarket notifications (510(k)s) eligible to be reviewed as a Special 510(k).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 rigorous design control procedures produce highly reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE). These well-defined modifications may include certain changes to indications for use that are not currently within the scope of the Special 510(k) Program. This draft guidance also clarifies the types of technological changes eligible to be reviewed as Special 510(k)s. Specifically, we are proposing to evaluate whether design and labeling changes can be reviewed under a Special 510(k) 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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.