Regulatory Focus™ > News Articles > FDA Updates Refuse to Accept Policy for 510(k)s

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Posted 05 August 2015 | By Michael Mezher 

FDA Updates Refuse to Accept Policy for 510(k)s

This week, the US Food and Drug Administration (FDA) released a new guidance detailing its criteria for accepting 510(k) submissions.

The new Refuse to Accept Policy for 510(k)s, which takes effect on 1 October 2015, will take precedence over three previous documents, the 2012 Refuse to Accept Policy for 510(k)s, 510(k) Refuse to Accept Procedures (K94-1) blue book memo and Premarket Notification (510(k)) Refuse to Accept Policy which were released in 2012, 1994 and 1993 respectively.


FDA uses the 510(k) application to clear devices which are deemed to be substantially equivalent to already marketed devices. Establishing that a device is substantially equivalent to an existing device allows a company to avoid submitting clinical data and other information in support of its application.

Upon receiving a 510(k), FDA has 15 days to review the application for completeness and determine if it meets the agency's acceptance criteria before notifying the sponsor of any deficiencies.

In FDA's 2012 Refuse to Accept Policy for 510(k)s, the agency said that by making its refuse to accept criteria more specific, it could free itself up from reviewing incomplete applications and drafting extensive letters to sponsors informing them of their application's deficiencies.

New Guidance

FDA says the purpose of the new guidance is to "enhance the consistency of [its] acceptance decisions and to help submitters better understand the types of information FDA needs to conduct a substantive review [and] clarify the necessary elements and contents of a complete 510(k) submission."

The changes in the new guidance are mostly made to the series of checklists and criteria contained within the appendices. These checklists allow companies to ensure they are including the required information with their submissions.

Notably, many of the changes in the checklist involve options which allow a company to provide alternative information in certain areas to provide additional clarity on the alternatives that can be used.

Additionally, several sections of the checklists have been deleted, leaving the overall checklist somewhat shorter. For instance, the previous version of the guidance included a section which read:

"Submission includes a comparison of the following for the predicate(s) and subject device:

  1. Indications for use
  2. Technology, including features, materials, and principles of operation."

This information is now covered by other more detailed questions elsewhere in the checklist.



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