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FDA Finalizes Three Critical Medical Device Guidance Documents

Posted 03 January 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released three final guidance documents regarding the submission of nearly all medical device applications made to the agency.

The guidance documents, released on 31 December 2012, pertain to three important aspects of the device submission process: submission, filing and acceptance of applications.

In the first guidance, eCopy Program for Medical Device Submissions, FDA has set out to require companies to submit in duplicate an electronic version of a paper submission. The system has been voluntary for some time, but FDA is moving to the system as the result of the requirements of the FDA Safety and Innovation Act (FDASIA), which requires FDA to bring the system into effect 24 months after the release of final guidance. Under that timeframe, the program would become effective on 1 January 2015.

[For a more complete explanation of the guidance, please see Regulatory Focus' 16 October 2012 article, "FDA Releases Guidance Document on Soon-to-be-Mandatory Device Submission Program."]

510(k) Submissions: Language Changes in Response to Industry Comments

In the second guidance, Refuse to Accept Policy for 510(k)s, FDA seeks to establish criteria it can use to refuse to accept for submission any 510(k) application that does not meet certain basic criteria established by the agency. The move is intended to conserve agency resources by siphoning off those applications with effectively no chance of making it through the device review process due to serious problems or omissions, preserving staff time for reviewing products that are more likely to obtain agency clearance.

While the process may sound good for both industry and FDA-industry gets a quicker response and a quicker chance to make necessary changes, while FDA saves time and money-industry trade group AdvaMed has panned the proposal, arguing that it lacks objectivity.

"Despite these very clear and concise explanations of the purpose of the acceptance review stated in the draft guidance, some items in the Acceptance Checklists require responses that could only be provided if a substantive review has been conducted," wrote Ruey Dempsey, AdvaMed's associate vice president for Technology and Regulatory Affairs in a 27 September 2012 letter to FDA. Medical device manufacturers Abbott and Zimmer made similar arguments in separate letters to the agency regarding the guidance.

In response to those complaints, FDA said it has "revised the language in these questions and added further instructions to FDA staff to more specifically state that only the presence of the information is required for acceptance, and that the adequacy of the information should only be assessed after acceptance and as part of the substantive review."

Elsewhere in the document, FDA explained that, in response to comments, it has modified language to "explain more clearly that the acceptance criterion requires only that the "analysis" or "discussion'" be present; the adequacy of this information should be assessed during the substantive review."

[For more information, please see Regulatory Focus' 10 August 2012 article, "New 510(k) Guidance Consolidates Pre-Review Policies."]

PMAs Set for Filing Review

The third and final guidance, Acceptance and Filing Review for Premarket Approval Applications (PMAs), is similar to the above 510(k) guidance in that it seeks to divide the review of submissions into two parts: acceptance and filing.

As Regulatory Focus reported back in July 2012, the guidance would apply to both PMAs and panel-track PMA supplements reviewed by FDA. Agency officials wrote the guidance would "provide a more efficient approach to ensuring that devices that have a reasonable assurance of safety and effectiveness reach patients as quickly as possible."

Unlike the 510(k) guidance, this one did not seem to receive industry comments, and FDA's Federal Register notice makes no note of any changes being made relative to the draft version of the guidance.

[For more information, please see Regulatory Focus' 30 July 2012 article, "Filing Review Process to See Changes Under Proposed CDRH Guidance."]

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