CDRH Makes Its New Year’s Guidance Resolutions

CDRH has set out its top priorities for draft and final guidance topics in 2016.

Marie Thibault

December 29, 2015

4 Min Read
CDRH Makes Its New Year’s Guidance Resolutions

Marie Thibault

CDRH has mapped out its guidance priorities for the new year, publishing the "A-list" of medical device guidance documents it intends to publish in FY 2016 and the "B-list" of guidances it plans to publish if possible. 

In 2015, the center published draft guidance on a number of the topics that are on the FY 2016 A-list to be finalized. One such topic, "Benefit-Risk Factors to Consider when Reviewing IDE Submissions," was the subject of a June 2015 draft guidance that was intended to help the medical device industry understand what information helps FDA make a determination about the benefit-risk tradeoff of a proposed IDE study. 

Another such topic, "Adaptive Design for Medical Device Clinical Studies," was highlighted by MD+DI as one of "The Six 2015 FDA Guidance Documents You Need to Know." Authors Gordon MacFarlane, PhD, RAC, Sandra D. White, MS, RAC, and Cynthia Nolte, PhD, RAC, wrote that "In our experience, adaptive designs have strengthened decision making, increased the quality of collected clinical evidence, and improved time-to-market and product valuations (particularly when applied across a portfolio)."

Several of the final guidance topics on the center's FY 2016 A-list were part of the FY 2015 A-list as proposed guidance topics, while some of the topics, like "Applying Human Factors & Usability Engineering to Optimize Medical Device Design" and "Regulatory Oversight of Laboratory Developed Tests" made repeat appearances after not being published in 2015.

CDRH also listed final guidance topics that were published 10, 20, 30, and 40 years ago to solicit feedback on whether these guidances should be changes or removed.

FDA is using the last few days of 2015 to reflect on the past year. In a December 29 FDA Voice blog post, Stephen M. Ostroff, MD, acting commissioner of food and drugs, reviewed the successes of 2015. He wrote:

"We saw the approval of several innovative devices that will make a positive difference in the lives of patients, including a device that extends the survival time of patients with brain cancer, and a transcatheter pulmonary valve that can be placed in certain patients with congenital heart disease, without requiring open heart surgery . . . And we've seen important progress in our device review program. Our average time to reach decisions on PMAs has dropped 36 percent since 2009. And not since 2001 FDA has approved as many medical devices under the original premarket approval pathway and the panel track supplement pathway (for significant changes to a PMA device) as we did this year—58 as of December 14th."

Here is CDRH's full A-list and B-list:

"Prioritized medical device guidance documents that the Agency intends to publish in FY 2016 ("A-list")

Final Guidance Topics

  • General Wellness Products

  • Medical Device Accessories

  • Benefit-Risk Factors to Consider when Reviewing IDE Submissions

  • UDI Direct Marking

  • Adaptive Design for Medical Device Clinical Studies

  • Incorporating Patient Preferences into Medical Devices Premarket Approvals, Humanitarian Device Exemptions, and De Novo Classifications

  • Applying Human Factors & Usability Engineering to Optimize Medical Device Design

  • Policy for Regulatory Oversight of Laboratory Developed Tests (LDTs)

  • Submission and Review of Sterility Information for Devices Labeled as Sterile

  • Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility)

  • Postmarket Surveillance Studies Under Section 522 of the Food, Drug, and Cosmetic Act

  • Medical Device Reporting (MDR) for Manufacturers

Draft Guidance Topics

  • Medical Device Decision Support Software

  • Use of Symbols in Labeling

  • 510(k) Modifications

  • Software Modifications

  • 510(k) Third Party Review Program

  • Companion Diagnostics Co-Development

  • Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices

  • UDI Convenience Kit

  • Public Notification of Emerging Postmarket Medical Device Signals

Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2016 ("B-list")

Final Guidance Topics

  • Reporting of Computational Modeling Studies in Medical Device Submissions

  • Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

  • Self-Monitoring Blood Glucose Meters for Over-the-Counter Use

  • Radiation Biodosimetry Devices

  • Finalizing existing draft guidance documents.

Draft Guidance Topics

  • Medical Device Interoperability

  • Patient Access to Information

  • Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies

  • Patient Matched Instrumentation for Orthopedics

  • Dual 510(k) and Clinical Laboratory Improvement Amendments Act (CLIA) Waiver by Application

  • Defining the Unique Device Identifier (UDI)

  • Critical to Quality Information for Abdominal Surgical Mesh Devices

  • Critical to Quality Information for Hydrophilic Coated and Hydrophobic Coated Vascular and Neurological Devices"

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie


About the Author(s)

Marie Thibault

Marie Thibault is the managing editor for Medical Device and Diagnostic Industry and Qmed. Reach her at [email protected] and on Twitter @MedTechMarie.

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