CDRH Lays Out Guidance Development Plans for Current Fiscal Year

| 07 November 2013 | By Alexander Gaffney, RAC, 

The US Food and Drug Administration (FDA) is giving the medical device industry a glimpse into the guidance documents it plans to release in the current fiscal year, including several of key interest to both the traditional device industry and emerging tech sectors.

As with the Center for Drug Evaluation and Research (CDER), which regularly posts its own guidance agendas, the Center for Devices and Radiological Health (CDRH) has divided its planned FY 2014 guidance documents into two groups: An "A-List" for those it prioritizes highly, and "B-List" guidance documents it prioritizes less than those on the "A-List."

Draft Guidance

Some of the guidance documents planned for release this year will be familiar to regular readers of Regulatory Focus, as FDA has already released draft versions of the guidances. For example, FDA has already released Questions and Answers About 517A, but has indicated that it plans to finalize the guidance this year.

Others are as-yet unknown to industry but have the potential to have a large impact. 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. The guidance was called for under the Food and Drug Administration Safety and Innovation Act (FDASIA), Section 617, and is due by August 2014.

Other A-List draft guidances set for release include one on hearing aids (already released), benefit-risk determinations in 510(k) submissions, and appropriate use of voluntary consensus standards in premarket submissions.

Less important in the eyes of FDA but still planned for release are six guidance documents, including several of interest to emerging fields of technology:

• Medical Device Decision Support Software
• Medical Device Accessories
• General Wellness Products
• Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
• Direct to Consumer (DTC) Genetic Testing: IVDs
• Device Interoperability

Final Guidance Documents

But for the most part, FY 2014 will be a flurry of activity not related to the new, but instead of finalizing existing draft guidance documents-something made clear by a B-List document planned for publication by FDA: Finalizing Existing Draft Guidance Documents.

On the A-List, FDA includes 12 documents it intends to finalize:

• 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 (GUDID)
• Design Considerations for Pivotal Clinical Investigations for Medical Devices (Already Completed)

One thing not on the list of planned guidance document: 3-D printing, which Jeffery Shuren said will be forthcoming before the end of 2015.

CDRH Fiscal Year 2014 (FY 2014) Proposed Guidance Development