The U.S. Food and Drug Administration Center for Devices and Radiological Health (CDRH) recently released a list of guidance documents it intends to publish in fiscal year 2020, as well as a list of previously issued final guidance documents, for which CDRH is seeking external feedback.
Significantly, CDRH notes that it intends to produce final guidance on its 510(k) Third Party Review Program, updates to its Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver application process and device-specific criteria guidance for safety and performance-based pathway implementation. Additionally, for draft guidance, CDRH notes its continued focus on cybersecurity of medical devices, revisions to its post-market surveillance program and revisions to procedures for handling post-approval studies.
Below is full a list of CDRH’s priority topics for final guidance, as well as draft guidance.
Final Guidance Topics
- Select updates for recommendations for CLIA waiver applications for manufacturers of in vitro diagnostic devices
- Recommendations for dual 510(k) and CLIA waiver by application studies
- 510(k) Third Party Review Program
- Safer technologies program for medical devices
- Process to request a review of FDA’s decision not to issue certain export certificates for devices
- Labeling recommendations for surgical staplers
- Nonbinding feedback after certain FDA inspections of device establishments
- Accreditation scheme for conformity assessment pilot program
- Recognition and withdrawal of voluntary consensus standards
- Clinical decision support software
- Multiple-function device products — policy and considerations
- Device-specific criteria guidance for safety and performance-based pathway implementation
Draft Guidance Topics
- Labeling and informed-decision checklist for breast implants
- Content of premarket submissions for management of cybersecurity in medical devices
- Distinguishing between medical device servicing and remanufacturing
- Computer software assurance for manufacturing, operations and quality system software
- Procedures for handling post-approval studies imposed by premarket approval order (revision)
- Post-market surveillance under Section 522 of the federal Food, Drug, and Cosmetic Act (revision)
- Unique device identification — policy on enforcement of Global Unique Device Identification Database submission requirements for certain class I devices
- Pragmatic generation of validity evidence for patient-reported outcome measures used in medical device submissions
- Device-specific criteria guidance for safety and performance-based pathway implementation
In addition to this initial list of priorities, CDRH released its “B-list” topics, which the agency will publish “as resources permit” during FY2020. These topics include the following:
Final Guidance Topics
- Blood glucose monitoring test systems for prescription point-of-care use
- Self-monitoring blood glucose test systems for over-the-counter use
- Replacement reagent and instrument family policy for in vitro diagnostic devices
- Unique device identification system — form and content of the unique device identifier
Draft Guidance Topics
- Point-of-care prothrombin time/international normalized ratio monitoring systems for professional use and prescription self-monitoring use
- Risk categorization for software as a medical device — FDA interpretation, policy and considerations
We will continue to monitor FDA’s guidance publications and provide further analysis on significant guidance documents as they are published. McGuireWoods is ready and able to assist with any of the topics above and help navigate any business or legal issues. For questions related to CDRH’s existing guidance, please consult the author or another member of the McGuireWoods life sciences team.