Good news for those Quality and Regulatory leaders eager to see what the FDA has in store for medical device companies in 2018! The FDA’s Center for Devices and Radiological Health (CDRH) has published its plans for medical device guidance through 2018. The plans are separated into two lists: a list of guidance documents that the FDA fully intends to publish in 2018 (referred to as the “A-list”), as well as a list of guidance documents that the FDA intends to publish as resources permit (referred to as the “B-list”). The lists announced by the FDA are as follows:
“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Draft Guidance Topics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
“B-list”
Final Guidance Topics
- Human Factors List of High Priority Devices
- Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics
- Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
Draft Guidance Topics
- Premarket Submissions for Patient Matched Guides to Orthopedic Implants
- Replacement Reagents Policy for Technologically Similar Instruments for In Vitro Diagnostic Devices
It is important to note that while the FDA is committed to addressing each and every item on these lists, there is no guarantee it will complete its entire agenda in 2018 due to resource constraints and unforeseen priorities that may arise. The FDA welcomes comments on these lists, including feedback on relative priority of the topics, suggestions for other guidance topics, and proposed wording on the A-list and B-list topics. Comments can be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or submitted electronically to http://www.regulations.gov.
Further details on these lists can be found on the FDA website at:
https://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm580172.htm
