CDRH Fiscal Year 2017 (FY 2017) Proposed Guidance Development and Focused Retrospective Review of Final Guidance

The lists below include guidance documents that CDRH intends to publish this fiscal year (FY2017), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn. We have provided 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 that issued in 2006, 1996, 1986, and 1976 subject to focused retrospective review. Although resource constraints and new issues that emerge over the course of the year may preclude CDRH from issuing every guidance document on the A-list and B-list and may require that CDRH issue guidance documents not on the lists, the A-list and B-list are intended to provide helpful information about CDRH’s current priorities for the upcoming fiscal year. CDRH plans to update all three lists every year.

During negotiations over the Medical Device User Fee Amendments of 2012 (MDUFA III) (Public Law 112-114), FDA agreed, in return from additional funding from industry, to meet a variety of quantitative and qualitative goals intended to help get safe and effective medical devices to market more quickly. Among other things, FDA agreed to:

• post annually a list of prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published each fiscal year (FY) (the “A-list”);
• post annually a list of device guidance documents that the Agency intends to publish as resources permit each fiscal year (the “B-list”);
• update our website in a timely manner to reflect the Agency’s review of previously published guidance documents, including the deletion of guidance documents that no longer represent the Agency’s interpretation of, or policy on, a regulatory issue, and notation of guidance documents that are under review by the Agency; and
• provide stakeholders an opportunity to provide feedback, including draft language for guidance documents.

Our experience over the years has shown that there are many reasons why CDRH does not complete the entire annual agenda of guidance documents it undertakes. Staff are frequently diverted from guidance development to other activities, including review of premarket submissions or postmarket problems. In addition, CDRH is required each year to issue a number of guidance documents we cannot know about in advance. These may involve newly identified public health issues. It will be helpful, therefore, to receive comments indicating the relative priority of different guidance topics to interested stakeholders. In addition, we intend to consider stakeholder feedback to the docket to help prioritize our allocation of resources to specific guidance topics on the lists.

On June 5, 2014, CDRH held a public workshop to provide stakeholders an opportunity to actively engage with Center representatives about the guidance development process, provide transparency into guidance priority development, promote dialogue on guidance process improvements, and generate ideas for assessing the impact of guidance. One question that was raised was how current previously issued final guidances remain. CDRH has resolved to address this concern through a staged review of previously issued final guidances in collaboration with stakeholders. CDRH would appreciate external feedback on whether any final guidances that issued in 2007, 1997, 1987, or 1977 should be revised or withdrawn. CDRH intends to provide such lists annually through fiscal year 2025 so that by 2025, FDA and stakeholders will have assessed the applicability of all guidances older than 10 years. For instance, in the annual notice for fiscal year 2018, CDRH expects to provide a list of the final guidance documents that issued in 2008, 1998, 1988, and 1978; the annual notice for fiscal year 2019 is expected to provide a list of the final guidance documents that issued in 2009, 1999, 1989, and 1979, and so on. CDRH will consider the information received from this retrospective review when determining priorities for updating guidance documents.

FDA has established docket FDA-2012-N-1021 for comments on any or all of the proposed fiscal year 2017 guidance documents or guidance documents subject to CDRH’s focused retrospective review. FDA would appreciate comments on all three lists, draft language on the proposed A-list and B-list topics, suggestions for new or different guidance documents, relative priority of guidance documents, and/or suggestions that CDRH revise or withdraw a final guidance document that issued previously as part of its retrospective review. FDA believes this docket is an important tool for receiving information from interested parties and for making information available to the public.

CDRH is considering developing a variety of guidance documents in fiscal year 2017. Specific topics and status as final and draft guidance document, are provided in the two lists:

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 each 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

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