FDA CDRH 2019 New Guidance Plan

FDA has posted their FY 2019 Proposed Guidance Development list with priorities. A link is provided below but here is the “A” list items:

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

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).

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