FDA Unveils List Of Soon-To-Be Published CDRH Guidance Docs

The FDA rolled out a list of guidance documents that the CDRH plans to publish in the next fiscal year, according to a recent entry in the Federal Register.

The list is broken down into "A-list" documents, which the agency "fully intends to publish," and "B-list" documents, which it will publish as resources permit.

The FDA published the guidance list to fulfill its promise to industry under the Medical Device User Fee Amendments (MDUFA) of 2012. In return for additional funding from device makers, the agency agreed to meet “a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly."

One of these commitments was the annual publication of a list of prioritized medical device guidance documents that the FDA intends to publish within 12 months (the A-list) and that it intends to publish “as the agency's guidance-development resources permit each fiscal year” (the B-
list).

The prioritized list of final guidance topics on the A-list is as follows:

• Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A
• Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
• Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act
• De Novo Classification Process (Evaluation of Automatic Class III Designation)
• 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
• Applying Human Factors and Usability Engineering to Optimize Medical Device Design
• In Vitro Companion Diagnostic Devices
• Global Unique Device Identification Database
• Design Considerations for Pivotal Clinical Investigations for Medical Devices

The A-list draft guidance topics are:

• Benefit-Risk Determinations in Premarket Notifications (510(k)s)
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions
• Custom Devices
• Hearing Aids and Personal Sound Amplification Products (PSAPs)

For the complete A- and B-lists, click here.

Industry and the public now have a chance to make statements on the documents by filing comments with FDA.

Regulatory Focus commented that "for the most part, FY 2014 will be a flurry of activity not related to the new, but instead of finalizing existing draft guidance documents."

However, the contents of some of the documents are still unknown to industry and could have a large impact, RF said. "For example, FDA says it plans to issue a new guidance on 'Custom Devices' within the next fiscal year. Those devices refer to ones customized for a particular person and not produced for mass-market purposes."

That guidance was "called for under the Food and Drug Administration Safety and Innovation Act (FDASIA), Section 617, and is due by August 2014," the report said.