FDA has posted their FY 2019 Proposed Guidance Development list with priorities. A link is provided below but here is the “A” list items:
Final Guidance Topics
- Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
- Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Direct Marking of Inventory
- Breakthrough Devices Program
- Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria
- The Least Burdensome Provisions: Concept and Principles
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
- Clinical and Patient Decision Support Software
- Multiple Function Device Products: Policy and Considerations
- Humanitarian Device Exemption (HDE) Program
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- The Special 510(k) Program
Draft Guidance Topics
- Content of Premarket Submissions for Cybersecurity of Medical Devices of Moderate and Major Level of Concern
- Surgical Staplers and Staples – Labeling Recommendations
- Non-binding Feedback After Certain FDA Inspections of Device Establishments
- Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
- Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies
- Computer Software Assurance for Manufacturing, Operations, and Quality System Software
- Patient Engagement in Clinical Trials
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Lifecycle Regulatory Requirements of Medical Device Servicing (Device Servicer vs Remanufacturer)
- Guidance on an Accreditation Scheme for Conformity Assessment of Medical Devices to FDA-Recognized Consensus Standards (ASCA).
Refer to the FDA announcement at this link. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm529396.htm
