CDRH Industry: FDA accepting comments on planned revisions to current 510(k) modifications guidance

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 2014-04930 onhttp://www.regulations.gov/a/2014-04930.