CDRH FY 2018 Proposed Guidance Development & Retrospective Review
CDRH Fiscal Year 2018 (FY 2018) Proposed Guidance Development and Focused Retrospective Review of Final Guidance
Three lists:
- A-List: fully intends to publish
- B-List: intends to publish as resources permit
- Focused retrospective review: guidances issued in 2008, 1998, 1988, and 1978
A-List
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Draft Guidance Topics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