CDRH Outlines Guidance Goals for Fiscal 2014

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has a full agenda on tap for fiscal year 2014, with plans to provide guidance on such topics as cybersecurity in premarket submissions, human factors and usability engineering for device design, and establishing a global unique device identification database (GUDID).

On its website, the center has posted two lists of draft and final guidance documents it hopes to publish this fiscal year. In addition to final guidance documents on cybersecurity, human factors, and the GUDID, the “A list” of top priorities includes the following topics:

• CDRH Appeals Processes: Questions and Answers About 517A
• Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act
• De Novo Classification Process
• The Pre-Submission Program and Meetings with FDA Staff
• The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
• Types of Communication During the Review of Medical Device Submissions
• Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents
• In-vitro Companion Diagnostic Devices
• Design Considerations for Pivotal Clinical Investigations for Medical Devices

In addition, the center has posted a secondary “B list” of documents that it says it will tackle if resources permit. It includes proposed draft guidance documents on medical device decision support software and device interoperability.

Six of the items on the “A list,” including the guidances on appeals process and in-vitro companion diagnostic devices, are making a return appearance from last year. As the center says, there are many reasons why it might not complete all guidances on the list because of other priority activities.

“In addition, at any time new issues may arise to be addressed in guidance that could not have been anticipated at the time the annual list is generated. These may involve newly identified public health issues,” according to a statement issued by the agency.

The center says it wants feedback on its lists. In particular, it asks for “comments indicating the relative priority of different guidance topics to interested stakeholders. In addition, we intend to consider stakeholder feedback to the docket to help prioritize our allocation of resources to specific guidance topics on the list.”

The lists come as a result of the 2012 renewal of the medical device user fee program. In return for additional funding from the manufacturing industry, the FDA has agreed “to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly,” according to an announcement of the lists in the Nov. 6 issue of the Federal Register.

The agency has established docket FDA-2012-N-1021 so the public may submit comments, suggest different guidance ideas, or recommend other priorities.

To view the full lists, visit: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm321367.htm