fda guidancesCDRH Fiscal Year 2018 (FY 2018) Proposed Guidance Development and Focused Retrospective Review of Final Guidance

Three lists:

  1. A-List:  fully intends to publish
  2.  B-List: intends to publish as resources permit
  3. Focused retrospective review: guidances issued in 2008, 1998, 1988, and 1978


Final Guidance Topics

  • Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types (revision)
  • Unique Device Identification: Policy Regarding Compliance Dates of Class I and Unclassified Devices
  • Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
  • Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases
  • Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics

Draft Guidance Topics

  • Export Certificates
  • Multifunctional Device Products: Policy and Considerations
  • The Least Burdensome Provisions: Concept and Principles
  • Humanitarian Devices Exemption (HDE) Program
  • 510(k) Third Party Review Program
  • Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
  • Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
  • The Application of Acceptable Uncertainty to Support Marketing Authorization Decisions for Medical Devices
  • Principles and Procedures for the Recognition and/or Withdrawal of Voluntary Consensus Standards
  • Validation of Automated Process Equipment Software



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