CDRH Offers Look at Upcoming Guidance Documents in FY 2019

Regulatory NewsRegulatory News | 03 October 2018 |  By 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday published three lists of guidance documents that may be published in the next fiscal year.

The guidance documents are captured in three lists: (1) a list of guidance documents that the agency “fully intends to publish” (known as the "A-list"); (2) a list of guidance documents that the agency intends to publish as resources permit (known as the "B-list"); and (3) a list of final guidance documents issued in 2009, 1999, 1989 and 1979 subject to retrospective review.

Under the A-list, FDA lists the following guidance documents:

Draft Guidance
  • Content of Premarket Submissions for Cybersecurity of Medical Devices of Moderate and Major Level of Concern
  • Surgical Staplers and Staples – Labeling Recommendations
  • Nonbinding 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).
Final Guidance
  • 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
For more information on the B-list and the other guidance documents FDA is considering changes to, as well as more information on how to comment on the guidance documents and FDA’s intentions in publishing these lists, see the link below.

CDRH Fiscal Year 2019 (FY 2019) Proposed Guidance Development


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