The FDA seeks comments on the draft guidance "Special 510(k) Program"

The U.S. Food and Drug Administration (FDA) is seeking comments on the draft guidance "The Special 510(k) Program" by November 27, 2018.

This guidance proposes to update the Special 510(k) Program for medical devices to both clarify existing policy and expand on the types of changes eligible for the program to improve the efficiency of 510(k) review.  This update includes certain changes to the indications for use and clarifies the types of technological changes that are appropriate to be reviewed as Special 510(k)s.

Under the current Special 510(k) Program, 510(k)s that include changes to the indications for use and/or changes in the fundamental scientific technology of the device as compared to the manufacturer’s own legally marketed predicate device are routinely converted to Traditional 510(k)s. This draft guidance, when final, is intended to update the Special 510(k) Program to expand the types of changes eligible for the Special 510(k) Program. Specifically, the FDA proposes that a design or labeling change to an existing device (including certain changes to indications for use) may be reviewed under a Special 510(k) when:

• The proposed change is made and submitted by the manufacturer authorized to market the existing device;
• Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change; and
• All performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format.

The Special 510(k) Program is available for manufacturers who are changing their own devices. When final, this guidance will replace the Special 510(k) policy in “The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications,” issued on March 20, 1998. The Abbreviated 510(k) policy within the 1998 guidance document will still be in effect for Abbreviated 510(k)s.

This draft guidance is not for implementation at this time, but is currently open for public comment for 60 days.  Comments should be submitted either electronically or in writing within 60 days of publication in the Federal Register. Comments can be submitted to http://www.regulations.gov/ under Docket No. FDA-2018-D-3304.

If you have general questions about this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.

Food and Drug Administration
Center for Devices and Radiological Health