FDA Announces FY 2013 Guidance Priorities, Seeks Public Input Including Draft Language

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The Food and Drug Administration Nov. 23 released a list of medical device guidance documents that it expects to complete in the fiscal year that began Oct. 1.

Higher-priority guidances on the agency's “A-list” include work on mobile medical applications, pre-submission meetings with FDA staff, and the refuse-to-accept policy for 510(k) or premarket notification applications, according to a website linked to a notice in the Nov. 26 Federal Register (77 Fed. Reg. 70,449).

On the website, the agency said it has two lists: the guidance documents “that the Agency fully intends to publish (the 'A-list'); and (2) a list of guidance documents that the Agency intends to publish as resources permit (the 'B-list').”

In addition, FDA said it invites comments on any or all of the guidance documents on the lists to docket FDA-2012-N-1021. The comments may include draft language on the proposed topics, suggestions for new or different guidance documents, and/or the relative priority of guidance documents, the agency said.

In the notice, FDA explained that during negotiations over the Medical Device User Fee Amendments of 2012 (MDUFA III), which is part of the FDA Safety and Innovation Act that the president signed in July, the agency agreed, “in return for additional funding from industry,” to meet certain goals intended to help get safe and effective medical devices to market more quickly. The commitments include annually posting a list of prioritized device guidance documents.

A-List Topics.

On the agency website, the A-listed final guidance document topics for FY 2013 are:

• refuse-to-accept (RTA) policy for 510(k) submissions, for which the agency recently completed a comment period (6 MELR 634, 10/17/12);

• acceptance and filing review for premarket approval (PMA) applications, also the subject of a recent comment period (6 MELR 592, 10/3/12);

• investigational device exemptions (IDE) for early feasibility device clinical studies, including certain first in human (FIH) studies, released as a draft in the fall of 2011 (5 MELR 705, 11/16/11);

• in vitro companion diagnostic devices, released as a draft in July 2011 (5 MELR 478, 7/27/11);

• design considerations for pivotal clinical investigations for medical devices, released in August 2011 as a draft (5 MELR 541, 8/24/11);

• the de novo classification process, released as a draft in fall 2011 and subject of a comment period ended in January (6 MELR 52, 1/25/12);

• evaluating substantial equivalence in the 510(k) program, issued as a draft in late 2011 (6 MELR 9, 1/11/12), with comments due in April (6 MELR 325, 5/16/12);

• the appeals process at the agency's Center for Devices and Radiological Health, issued as a draft in late 2011 with its comment period ended in April (6 MELR 12, 1/11/12);

• device classification product codes, the subject of a draft guidance from January (6 MELR 16, 1/11/12);

• mobile medical applications, subject of a draft in July 2011 (5 MELR 476, 7/27/11);

• the pre-submission program and meetings with FDA staff, the subject of a recent comment period on a draft guidance (6 MELR 662, 10/31/12);

• the “eCopy” or new electronic copy program for medical device submissions, the subject of a recent draft (6 MELR 635, 10/17/12) with a comment period that ended in mid-November (see related item); and

• 510(k) submissions for devices that include antimicrobial agents, the subject of a draft announced in 2007 (72 Fed. Reg. 39,630, July 19, 2007).


The agency also listed draft topics in its A and B lists.

FDA noted that it is not required to publish every guidance on either list “if the resources needed would be to the detriment of meeting quantitative review timelines and statutory obligations.” The agency also said it “is not precluded from issuing guidance documents that are not on either list.”

FDA said it anticipates that feedback from stakeholders, including draft language for guidance documents, will allow CDRH to better prioritize and more efficiently draft guidances that will be useful to industry and other stakeholders.

The website is http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm321367.htm.

Comments on the priorities should be sent to http://www.regulations.gov, and the comments docket is FDA-2012-N-1021.

The Nov. 26 notice is at http://www.gpo.gov/fdsys/pkg/FR-2012-11-26/html/2012-28539.htm.

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