FDA Announces Medical Device Guidance Agenda For 2016

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) has announced the priority, “A-list” of medical device guidance documents it intends to publish for fiscal year 2016, as well as a secondary, “B-list” of guidance the agency plans to publish as guidance-development resources permit.

FDA and industry stakeholders believe that patients' perspectives should become more integrated in device development, and doing so could provide impetus for the industry and government's thrust toward personalized/precision medicine, as reflected in the guidance agenda.

The agency in May issued a draft guidance to assist manufacturers on how to utilize patient preference information (PPI) in the life-cycle of a medical device, including devices under review for their novel technology (de novo process), or those indicated for an unmet need (humanitarian device exemption, or HDE).

Now, to provide more clarity, the agency says it will publish next year final guidance on Incorporating Patient Preferences into Medical Devices Premarket Approvals, Humanitarian Device Exemptions, and De Novo Classifications, according to the official announcement.

Related to obtaining more patient data to support its reviews, FDA also plans to issue draft guidance on the Use of Real-World Observational Patient Data to Support Decision Making for Medical Devices, including possibly the use of "big data" studies of electronic health records (EHRs) that can yield insights beyond what traditional clinical trials can provide.

Also slated for publication are final guidance on Postmarket Surveillance Studies and Medical Device Reporting (MDR) for Manufacturers. Said documents would support FDA's newly-created National Medical Device Postmarket Surveillance System (MDS) intended to help assess real-world device performance and uphold patient safety.

An important piece of MDS is the FDA's unique device identification (UDI) system and operation of a Global UDI Database (GUDID) for unambiguous and exhaustive device tagging. To help manufacturers meet staggered deadlines of UDI compliance, FDA intends to publish final guidance on UDI Direct Marking, and draft guidance on UDI Convenience Kit, Use of Symbols in Labeling, and Defining the Unique Device Identifier (UDI).

Other documents that could bring clarity to areas of growing industry importance are final guidance on Policy for Regulatory Oversight of Laboratory Developed Tests (LDTs) and draft guidance on Medical Device Interoperability.

FDA also plans to publish final guidance on Applying Human Factors & Usability Engineering to Optimize Medical Device Design. FDA in 2011 published draft guidance on applying human factors and usability engineering to optimize medical device design, and "many from industry and the FDA are operating as if it is in its final form," writes Andy Schaudt, director of usability services for the National Center for Human Factors in Healthcare at the MedStar Institute for Innovation, in an MDO guest column. The final document on human factors should better serve engineers in the design and development cycle.

In addition, as part of its annual retrospective review of guidance documents, FDA announced that it would review final guidance documents issued in 2006, 1996, 1986, and 1976. The agency wants external feedback from stakeholders if these documents should be revised or withdrawn. FDA says it will conduct such reviews of older documents published in ten-year gaps, annually through fiscal year 2025, by which time all guidance older than ten years will have been assessed for current applicability.

According to the FDA's notice in the Federal Register, the agency is seeking stakeholder input and comments on any or all of the guidance documents on the lists. It states, "FDA has established the docket number (FDA-2012-N-1021) where comments on the FY 2016 lists, draft language for guidance documents on those topics, suggestions for new or different guidances, and relative priority of guidance documents may be submitted and shared with the public." 

Here's the complete “A-list” of guidance documents.

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

Here's the “B-list”, or the list of guidance documents intended for publication as FDA's resources permit:

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