Medical Devices

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


Introduction

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which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn.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 2007, 1997, 1987, and 1977 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.

CDRH would appreciate comments on any or all of the guidance documents on the three lists to docket FDA-2012-N-1021. Specifically, we are seeking comments on the relative priority of guidance documents. Comments could also include draft language on the proposed A-list and B-list topics, suggestions for new or different guidance documents, for which we request that commenters state the potential guidance topic, reasons the guidance is needed, and proposed policy or information for FDA to consider on the topic. For the retrospective review list, we are seeking suggestions regarding which final guidances should be revised or withdrawn to help inform CDRH's retrospective review of existing final guidances. If a recommendation is made to withdraw or request an existing guidance document, we request that commenters also include information regarding why the guidance document should be revised or withdrawn and, if applicable, how it should be revised. We also welcome any additional feedback for improving the guidance program and the quality of CDRH guidance documents. CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public. The feedback received is critical to the CDRH guidance program to ensure that we meet stakeholder needs. Note that current FDA and CDRH guidance documents can be found on the CDRH Guidance Document Web page.

Why is CDRH posting lists of guidance documents it intends to issue?

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.

Does CDRH expect to complete the A-list and B-list?

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.

Why is CDRH posting a list of guidance documents as part of its retrospective review?

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.

How do I comment on these lists or a particular guidance document?

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.

Interested persons should submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. It is only necessary to send one set of comments. Identify comments with docket number FDA-2012-N-1021. Received comments will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. For more detailed information on submission of comments, please refer to the Federal Register notice entitled "Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2017 Proposed Guidance Development."

What guidance documents does CDRH intend to issue or develop during FY 2017?

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

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

1977 Final Guidances

1987 Final Guidances

1997 Final Guidances

2007 Final Guidances

Page Last Updated: 08/03/2017
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