FDA Publish 510K Guidance – When to Submit a 510K for a Change

FDA developed this draft document to provide guidance to manufacturers on when to submit a premarket notification submission (510(k)) for changes or modifications made to that manufacturer’s1 previously cleared medical device. The underlying principles that FDA uses to determine when a 510(k) is necessary for a modified device are explained here, and examples are provided for additional clarity. When final, this guidance will supersede the 1997 version of the guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device.
In 2010, FDA initiated a review of its process for premarket review of medical devices and undertook two significant initiatives to improve the Agency’s medical device premarket review programs. In August 2010, FDA released two reports, including the analyses and recommendations that suggested changes were needed to improve the predictability, consistency, and transparency of these programs. After receiving input from industry, stakeholders and the public, in January 2011, FDA announced 25 specific actions that the Agency will take to improve the premarket review programs. Updating the 1997 version of the guidance document, Deciding When to Submit a 510(k) for a Change to an Existing Device, is one of these actions.

The recommendations in this draft guidance document are consistent with FDA policy for when a modification to a device does – and does not – require the submission of a 510(k).

The guidance has been updated, however, to address issues associated with software and other rapidly changing technologies, and to provide greater clarity about changes that do not trigger the need for a new premarket submission. This guidance uses examples of modifications to devices involving such technologies to illustrate changes that require a new 510(k), and changes that may simply be documented in accordance with a manufacturer’s existing Quality System without prompting the need for a new 510(k) submission. FDA believes increased certainty about the regulatory conseque

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