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:

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Draft Guidance Topics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

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.
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