Oct 3, 2018

EMERGO SUMMARY OF KEY POINTS:

  • US FDA’s medical device oversight division identifies key guidance publication plans for 2019.
  • Top FDA Center for Devices and Radiological Health (CDRH) guidance topics for 2019 include cybersecurity, Least Burdensome Provisions and Unique Device Identification (UDI) implementation and compliance issues.
  • Lower-priority CDRH guidance documents may also see publication in 2019 if resources permit.

Updated cybersecurity requirements for medical device premarket submissions, Abbreviated and Special 510(k) program refinements, and medical software policy changes stemming from the 21st Century Cures Act rank highly among topics for a new list of guidance documents the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to publish during the agency’s 2019 fiscal year.

CDRH’s new list of final and draft guidances under development for 2019 reflects the division’s priorities in terms of public health and increasing regulatory process efficiencies based on available resources. Proposed guidance documents have been grouped into higher-priority (A List) and lower priority (B List) groups.

Broad topics such as updates to CDRH’s cybersecurity regulatory approach, Least Burdensome Provisions and benefit-risk determination factors as well as program-specific guidelines covering 510(k), Unique Device Identification (UDI) and other policies topped the center’s list for the coming fiscal year.

Top-priority CDRH guidance topics for 2019

A-list final guidance documents CDRH plans to publish in 2019 cover topics such as:

  • Special 510(k), Breakthrough Devices and Humanitarian Device Exemption (HDE) programs, as well as on criteria for expansion of FDA’s Abbreviated 510(k) program;
  • UDI compliance deadlines for Class I and unclassified devices, as well as for direct marking of inventory;
  • FDA’s Q-Submission (Q-Sub) program policies;
  • Policies covering multiple-function devices;
  • Clinical and patient decision support software, as well as changes to current medical software policies mandated by the 21st Century Cures Act;
  • Least Burdensome Provisions, as well as uncertainty considerations for benefit-risk determinations in Premarket Approval (PMA) reviews, De Novo device classifications and HDEs.

Among draft-guidance A List subjects identified by CDRH for 2019 publication, industry and stakeholder anticipation runs high for new cybersecurity requirements and recommendations under development for devices presenting moderate to high levels of concern in terms of public safety risks and vulnerabilities.

Additional high-priority draft guidances planned for the 2019 fiscal year address issues including:

  • An Accreditation Scheme for Conformity Assessment (ASCA) of medical devices to FDA-recognized consensus standards;
  • Clinically focused guidances including updated recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications for IVD manufacturers; policies for patient engagement in clinical trials; and recommendations for dual 510(k) and CLIA waivers;
  • A computer software assurance program for manufacturing, operations and quality system software;
  • Guidance for what to include in premarket submissions for software contained in devices;
  • Lifecycle regulatory requirements for medical device servicing.

Lower-priority guidances on CDRH’s 2019 radar

CDRH’s plans to publish B List guidance documents is contingent upon availability of development and publication resources, and cover more niche and targeted topics.

Proposed B List final guidances for 2019 pertain to topics including UDI requirements for convenience kits; form and content requirements for Unique Device Identifiers; and conformance of medical X-ray imaging devices to IEC standards.

Finally, B List draft CDRH guidances tentatively slated for 2019 publication address non-clinical testing and clinical considerations for implanted brain-computer interface devices, and 510(k) submission requirements for continuous ventilators.

Emergo by UL will monitor CDRH's progress over the course of 2019 and provide additional reporting and analysis of individual guidances as they are published.

Related US FDA medical device regulatory resources from Emergo: