FDA Announces Proposed Guidance for FY 2019


Posted November 2, 2018

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has announced the guidance documents it intends to publish in fiscal year (FY) 2019, and the planned areas of focus include prioritizing digital health, advancing device safety and security, and engaging patients. The proposed guidance documents would be comprised of:

  • An “A-list” that the agency fully intends to publish.
  • A “B-list” that the agency intends to publish as resources permit.
  • A list of final guidance documents published in 2009, 1999, 1989, and 1979 subject to focused retrospective review.

“FDA guidances explain the agency’s interpretation of, or policy on, a regulatory issue,” CDRH Director Jeff Shuren said in a statement. “The agency and its centers prepare guidances for industry, but also for other customers, including our own staff, to address areas including design, manufacturing, and testing of regulated products, scientific issues, content and evaluation of applications for product approvals, postmarket surveillance, and inspection and enforcement policies. … We are committed to reviewing previously published final guidance documents, updating, or deleting guidance documents that no longer represent the agency’s current thinking on a regulatory issue.”

The agency will accept comments on the proposed scope of work, particularly on the relative priority of the planned guidance documents, until Dec. 3. Comments also could include draft language on the topics and suggestions and rationales for guidance on new or different topics. For its staged retrospective review, the agency is interested in suggestions about which final guidance document should be revised or withdrawn.

In his statement, Shuren highlighted the regulatory themes of the planned documents:

  • Prioritizing digital health
  • Advancing device safety and security
  • Offering more flexibility and options for premarket submissions
  • Sustaining high-quality services
  • Efficient oversight
  • Handling uncertainty in devices
  • Engaging patients

The A-List

The prioritized medical device guidance that the agency intends to publish in FY 2019 are as follows:

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
  • 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)

 The B-List

As resources permit, the agency will publish final and draft guidance on these topics:

 Final Guidance Topics

  • Utilizing Animal Studies to Evaluate Organ Preservation Devices
  • Unique Device Identification: Convenience Kits
  • Medical X-Ray Imaging Devices Conformance with IEC Standards
  • Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
  • Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)

Draft Guidance Topics

  • Nonclinical Testing and Clinical Considerations for Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation
  • Continuous Ventilators – Premarket Notification (510(k)) Submissions

Retrospective Review

Final guidance documents subject to retrospective review are as follows:

 

1989 Final Guidance

 

1999 Final Guidance

 

2009 Final Guidance