Medical Devices

Report To Congress On The Premarket Process

This is inform you that the FDA is accepting comments until June 4, 2014, for the Report to Congress; Report on FDA's Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices. The report announces the agency’s intention to make targeted revisions to the current
510(k) modifications guidance, such as clarifying certain issues, providing additional examples demonstrating when 510(k)s are necessary/not necessary for changes to legally marketed 510(k) devices, and accounting for evolving technology, while retaining the general policy and approach of the current guidance.

The FDA invites comments on this report until the June deadline, through docket number
FDA-2014-N-0237-0001 on http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0237-0001.

Thank you for your continued support.

Food and Drug Administration
Center for Devices and Radiological Health

Page Last Updated: 06/24/2014
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