News Feature | December 29, 2016

FDA Issues List Of Priority Device Guidances For 2017

By Jof Enriquez,
Follow me on Twitter @jofenriq


The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has posted the lists of medical device guidance documents it will prioritize for fiscal year 2017, pursuant to the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114).

CDRH provides three lists: (1) a list of guidance documents that the Agency fully intends to publish (the "A-list"); (2) a list of guidance documents that the Agency intends to publish as resources permit (the "B-list"); and (3) a list of final guidance documents issued in 2007, 1997, 1987, and 1977 subject to focused retrospective review, as well as possible revision or withdrawal.

Among the A-list are final guidance documents on medical device cybersecurity, next-generation sequencing-based diagnostic devices, and the use of real-world evidence (RWE) to aid regulatory decision-making. Cybersecurity and RWE also are included in CDRH’s top ten science priorities for 2017, announced in September.

Included in the B-list are final guidance documents on unique device identification (UDI) and investigational device exemption (IDE) categories to support CMS coverage decisions. Also included is the draft guidance on electromagnetic compatibility of electrically powered medical devices, developed with the help of early stakeholder input.

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 that were not published in FY 2016, but were deemed high priority through stakeholder feedback, are now on the annual agenda for FY 2017, according to RAPS.

FDA says in a notice in the Federal Register that it welcomes comments on any or all of the guidance documents on the FY 2017 lists, allowing CDRH to better prioritize and more efficiently draft or finalize guidances, and to delete guidance documents that no longer represent the Agency's interpretation, thinking, or policy on a regulatory issue.

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 in FY 2017 as guidance-development resources permit ("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

Guidance documents subject to CDRH's focused retrospective review during FY2017

1977 Final Guidances:

  • Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22)
  • Guidance ('Guidelines') for Evaluation of Tubal Occlusion Devices
  • Emission Delay - Remote Interlock Connector (Laser Notice 21)
  • Guidance ('Guidelines') for Evaluation of Fetal Clip Electrode
  • Optional Interlocks - Labeling (Laser Notice 17)
  • Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16)

1987 Final Guidances:

  • Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)
  • ODE Executive Secretary Guidance Manual G87-3
  • User Instructions - Multi Axis Workstations (Laser Notice 39)
  • Master Files Part III; Guidance on Scientific and Technical Information
  • Color Additive Petitions
  • Importation for Investigation And Evaluation (Laser Notice 38)
  • Condoms: Inspection and Sampling at Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on 4/8/87)
  • Industry Representatives on Scientific Panel

1997 Final Guidances:

  • Industry Supported Scientific and Educational Activities
  • Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944) 
  • Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis
  • Convenience Kits Interim Regulatory Guidance
  • Premarket Notification 510(k) Guidance for Contact Lens Care Products
  • Design Control Guidance For Medical Device Manufacturers
  • Non-Invasive Blood Pressure (NIBP) Monitor Guidance
  • Medical Device Reporting for Manufacturers
  • Reviewers Guidance Checklist For Intramedullary Rods
  • Review Criteria For Assessment Of Rheumatoid Factor (Rf) In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (Eia), Enzyme Linked Immunosorbent Assay (Elisa), Particle Agglutination Tests, And Laser And Rate Nephelometry
  • 510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants
  • Electrocardiograph (ECG) Electrode
  • Electrocardiograph (ECG) Lead Switching Adapter
  • Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators
  • Third Party Review Guidance For Vitreous Aspiration & Cutting Device Premarket Notification (510(k))
  • Guidance for Submitting Reclassification Petition
  • PMA Review Statistical Checklist

2007 Final Guidances:

  • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Remote Medication Management System
  • Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions
  • Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)
  • Compliance Guide for Cabinet X-Ray Systems
  • Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses
  • CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition
  • Guidance for Industry and FDA Staff - Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions
  • Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs)
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies
  • Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission
  • Pharmacogenetic Tests and Genetic Tests for Heritable Markers
  • Guidance for Industry and FDA Staff - Pre-Clinical and Clinical Studies for Neurothrombectomy Devices
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
  • Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material
  • Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis
  • Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions
  • In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path - Guidance for Industry and FDA Staff
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems
  • Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53)
  • Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays