FDA Announces FY 2014 Guidance Priorities, Seeks Public Input Including Draft Language

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

By Nathaniel Weixel  

Nov. 5 --The Food and Drug Administration Nov. 5 released a list of medical device guidance documents that it aims to complete in the fiscal year that began Oct. 1.

Higher-priority guidances on the agency's “A-list” for fiscal year 2014 include questions and answers about the Center for Devices and Radiological Health's appeals process, the de novo classification process, in vitro diagnostics and how to protect devices from cybersecurity threats, according to a website linked in a Nov. 6 Federal Register notice (78 Fed. Reg. 66,746).

Two Priority Lists

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').” The FDA did not list any specific final guidance topics in its “B-list.”

The FDA in the notice said 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 FDA said it invites comments on any or all of the guidance documents on the lists. The comments, which should be sent to docket FDA-2012-N-1021, 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, the FDA said that during negotiations over the Medical Device User Fee Amendments of 2012 (MDUFA III), which is part of the FDA Safety and Innovation Act, 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-Listed Guidances

On the agency website, the A-listed final guidance document topics for FY 2014 are:


• Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A, for which comments on the draft were due in August (7 MELR 536, 8/21/13);

• Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, also the subject of a recent comment period for its draft (7 MELR 612, 10/2/13);

• Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act, issued as a draft in February (7 MELR 111, 2/20/13);

• De Novo Classification Process (Evaluation of Automatic Class III Designation), released as a draft in fall 2011 and subject of a comment period that ended in January 2012 (6 MELR 52, 1/25/12);

• Pre-Submission Program and Meetings with FDA Staff, for which comments on a draft were due in October 2012 (6 MELR 662, 10/31/12);

• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications, which was released as a draft in December 2011 (6 MELR 9, 1/11/12);

• Types of Communication During the Review of Medical Device Submissions, the draft of which was subject to a comment period that ended in June (7 MELR 385, 6/12/13);

• 510(k) Submissions for Medical Devices that Include Antimicrobial Agents, the subject of a draft announced in 2007 (72 Fed. Reg. 39,630, July 19, 2007).;

• Applying Human Factors and Usability Engineering to Optimize Medical Device Design, issued as a draft in 2011 (5 MELR 423, 6/29/11);

• In Vitro Companion Diagnostic Devices, also issued as a draft in 2011 (5 MELR 478, 7/27/11);

• Global Unique Device Identification Database, which was released in September as a draft along with a final rule (7 MELR 605, 10/2/13); and

• Design Considerations for Pivotal Clinical Investigations for Medical Devices, which was finalized and announced in the Nov. 7 Federal Register (78 Fed. Reg. 66,941, Nov. 7, 2013) (see related item).


Draft Guidance Topics

The agency also listed draft topics in its A and B lists. Some of the A-list draft topics include assessing the benefit-risk determinations in 510(k) submissions, custom devices and the appropriate use of voluntary consensus standards in premarket submissions. Another A-list draft guidance -- on hearing aids and personal sound amplification products-- also was announced in the Nov. 7 Federal Register (78 Fed. Reg. 66,940) (see related item).

The B-listed draft guidance topics include medical device decision support software, transfer of ownership of a premarket notification or 510(k), direct-to-consumer genetic testing (in vitro devices) and device interoperability.

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


To contact the reporter on this story: Nathaniel Weixel in Washington at nweixel@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

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

Request Health Care on Bloomberg Law