To File or Not to File, That is the Question

Monday, August 08, 2011

FDA released the DRAFT Guidance, 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device, on July 27, 2011 which when finalized will replace the 1997 version of the guidance document.
The implementation of the Quality System regulation has provided a mechanism for manufacturers/sponsors to document modifications to their devices.

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 was one of the actions.

The guidance has been updated

  • to address issues associated with software and other rapidly changing technologies,
  • to provide greater clarity about changes that do and do not trigger the need for a new premarket submission, and
  • to identify gray areas where the FDA recommends sponsors/manufacturers speak to the agency before determining whether a new 510(k) should be submitted.


The guidance reminds us that the modified device should be compared to the most recently cleared version of that device and submission of a new 510(k) is based on whether the modification could significantly affect safety or effectiveness and whether it is a major change in the intended use of the device.

The most notable difference is that the guidance document no longer includes the flowcharts and the removal of the separate section for materials changes for IVDs. The removal of the flowchart makes sense as the new guidance provides three options for your device modification questions –

  • No 510(k) required, document modification using your quality system
  • Yes 510(k) required
  • Gray area – discuss device modification with FDA before determining whether a new 510(k) should be submitted


Overall the draft guidance provides clarification and examples in line with current technologies to help manufacturers/sponsors with their assessments on whether a 510(k) submission is required for the modification of their device.


Tags: 510(k), CDRH

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