Regulatory Focus™ > News Articles > In Unusual Move, FDA Withdraws OMB Submission to Focus on Changes to Device Program

In Unusual Move, FDA Withdraws OMB Submission to Focus on Changes to Device Program

Posted 04 January 2013 | By Alexander Gaffney, RAC

If you're waiting for the US Food and Drug Administration's (FDA) guidance on planned changes to its medical device pre-submission meeting program, you may have to wait a bit longer.

In a highly unusual Federal Register notice on 4 January 2013, FDA explained that it was withdrawing an earlier 11 December 2012 Federal Register notice in which it announced that it had submitted for review the guidance document The Pre-Submission Program and Meetings with FDA Staff.

That notice had been posted under the terms of the Paperwork Reduction Act of 1995, which requires federal agencies to regularly submit to the Office of Management and Budget (OMB) guidance documents and regulations for review. OMB's Office of Information and Regulatory Affairs (OIRA) reviews the documents to ensure their continued cost-effectiveness and compliance with the latest government best practices, such as the clarity of language used.

So, why the withdrawal? FDA's Register notice doesn't provide much in the way of detail, saying only that it has been unable to finalize the "policy document" underlying its submission to OMB, and is thus "withdrawing the proposed collection of information." FDA typically collects comments from the public and industry regarding any documents it sends to OMB for review.

Another potential reason for the delay-unconfirmed by FDA-is that the agency is in the midst of overhauling the guidance in its entirety. In June 2012, FDA released an updated draft guidance of a document by the same name in which it looks to dramatically expand the current pre-submission program to include 510(k) substantial equivalence, premarket approval (PMA), and humanitarian device exemption (HDE) applications.

Currently, the program is only geared toward providing advice and guidance to sponsors of investigation device exemption (IDE) applications. In that draft guidance, FDA explained that the program has gone unchanged since 1995-eight years before even the passage of the first Medical Device User Fee Act was first passed into law. The guidance, FDA explained, is in dire need of an update to reflect its broader scope and incorporate additional changes.

Regulatory Focus put in a request to FDA to confirm details and determine when the draft guidance-the public comment period for which ended on 11 October 2012-might be made available in its final form, and will update this space accordingly.

[For more information on the pre-submission guidance, please see Regulatory Focus' 12 July 2012 story, "Changes Coming to Medical Device Pre-Submission Program."]

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