CDRH Lays Out Guidance Plans for FY 2017

Regulatory NewsRegulatory News | 22 December 2016 |  By 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released a list of 12 final guidance documents and four draft guidances that it will make a priority to publish in FY 2017.

The final guidance documents on the so-called “A-list” deal with some hot-button issues, including the use of real world evidence (which is also included on CDRH’s top 10 list of science priorities for 2017) to support medical device regulatory decisions, as well as device cybersecurity and next generation sequencing-based diagnostic devices.

CDRH also released a list (known as the “B-list”) of five final guidance topics and eight draft guidance topics that the agency hopes to publish, resources permitting.

In review of FY 2016, CDRH says it issued 20 of 33 guidances on the FY 2016 list (14 from the A-list, 6 from the B-list). Several guidance documents on the FY 2016 lists that were not published within FY 2016 are now on the annual agenda for FY 2017.

These lists were released as part of FDA’s obligations under the Medical Device User Fee Amendments of 2012 (MDUFA III), as outlined in Thursday’s Federal Register:

Prioritized medical device guidance documents that the agency intends to publish in FY 2017 ("A-list")

Final Guidance Topics

  • Postmarket Management of Cybersecurity in Medical Devices
  • Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types
  • Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
  • Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions
  • Suggested Format for Developing and Responding to Deficiencies
  • Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics
  • Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases
  • Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS) – Based In Vitro Diagnostics
  • Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers
  • Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
  • 510(k) Third Party Review Program
  • New or revised procedural guidances for MDUFA IV implementation

Draft Guidance Topics

  • IDE Submission, Content, Organization, Interactions
  • Update to Section V Demonstrating Insignificant Risk of an Erroneous Result in the Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices guidance
  • Dual 510(k) and CLIA Waiver
  • New or revised procedural guidances for MDUFA IV implementation

Device guidance documents that the agency intends to publish, as the agency's guidance-development resources permit in FY 2017 ("B-list")

Final Guidance Topics

  • Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
  • Medical Device Development Tools (MDDT)
  • FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
  • Unique Device Identification: Direct Marking of Devices
  • Technical Considerations for Additive Manufactured Devices

Draft Guidance Topics

  • Standard Content and Format for Patient Labeling of Medical Devices
  • Standard Content and Format for Healthcare Provider Labeling of Medical Devices
  • Patient Matched Instrumentation for Orthopedic Devices
  • Utilizing Simulated Animal Transplant Models to Evaluate the Safety of Perfusion-based Organ Preservation Devices
  • Strategy to Assess the Credibility of Computational Modeling Studies
  • Related Replacement Reagent and Instrument Policy
  • Unique Device Identification System: Defining the Labeler
  • Considerations to Support a Claim of Electromagnetic Compatibility for Medical Electrical Equipment and Medical Electrical Systems

What guidance documents are subject to CDRH's retrospective review during FY2017?

1977 Final Guidances

1987 Final Guidances

1997 Final Guidances

2007 Final Guidances



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