FDA Announces Its New Year’s Resolutions for 2016

The U.S. Food and Drug Administration has made its New Year’s resolutions public, listing the guidance documents the Center for Devices and Radiological Health intends to publish during the 2016 fiscal year.

Its guidance priorities include the application of human factors and usability engineering to medical device design, as well as incorporating patient preferences into device premarket approvals.
The 21-item “A-list” contains the final and draft guidance topics the agency “fully intends to publish,” while the shorter “B-list” specifies items that will be released “as resources permit.” The agency also listed final guidance topics published in 1976, 1986, 1996, and 2006 to get feedback on whether these documents should be revised or removed.

The FDA said in its online notice that based on experience, it will likely not complete all of the items listed and will rely on stakeholder input to prioritize how resources are allocated. The agency invited “interested persons to submit comments on any or all of the guidance documents on the three lists,” including draft language for A- and B-list topics or suggestions for other topics that should be addressed in future guidance documents. Comments can be submitted electronically through www.regulations.gov.

2016 A-list
Final Guidance Topics

• General wellness products
• Medical device accessories
• Benefit–risk factors to consider when reviewing investigational device exemption submissions
• Unique device identifier (UDI) direct marking
• Adaptive design for medical device clinical studies
• Incorporating patient preferences into medical device premarket approvals, humanitarian device exemptions, and de novo classifications
• Applying human factors and usability engineering to optimize medical device design
• Policy for regulatory oversight of laboratory developed tests
• 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 for manufacturers

• 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

• 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

• 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 waiver by application
• Defining the UDI
• Critical to quality information for abdominal surgical mesh devices
• Critical to quality information for hydrophilic coated and hydrophobic coated vascular and neurological devices