FDA’s CDRH Guidance Tempers 2015 Goals with a Dash of Pessimism
Unlike its sister Center for Drug Evaluation & Research (CDER), CDRH’s (Center for Devices & Radiological Health) new proposed guidance development and goals for 2015 reminds industry not to get its hopes up too high. “Our experience over the years has shown that there are many reasons why CDRH does not complete the entire annual agenda of guidance documents it undertakes,” it admits toward the front of the new document. CDER emerges as the more world-weary older sibling, optimism tempered a bit by experience in the real world.
The agency’s priorities guidance lists keep it pretty simple: the A-list are guidance’s it “fully intends” to publish. The B-list are ones it will publish “as resources permit.” CDRH reminds us that if we weigh in heavily on a particular guidance, it’s always possible the Center will move it up the waiting list.
They list just over a dozen final guidance topics and draft guidance topics on their A-list, as it were. Those include:
- Applying Human Factors and Usability to Optimize Medical Device Design
- 510(k) Submissions for Medical Devices that Include Antimicrobial Agents
- Balancing Premarket and Postmarket Data Collection for Devices Subject to Market Approval
- FDA Notification and Medical Device Reporting for Laboratory Developed Tests
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
A-list draft guidance topics include:
- Medical Device Accessories
- Medical Device Decision Support Software
- Benefit-Risk Factors to Consider When Reviewing IDE Submissions
- Adaptive Design for Medical Device Clinical Studies
- UDI FAQs.
The B-list is shorter. The only Final Guidance Topic it holds is one finalizing existing draft guidance documents (see above).
It does include some draft guidance topics we might see in 2015, though it’s not so likely given CDRH’s workload. Here are a few:
- Medical Device Interoperability
- 3D Printing
- Use of Symbols in Labeling
CDRH further lists some two dozen retrospective guidances it is due to review in 2015. Those mostly focus on specific guidance for various 501(k) premarket notifications, e.g., short-term and long-term intravascular catheters, electromyography needle electrodes, and powered tables and multifunctional physical therapy tables.
All in all, CDRH is to be applauded to laying out what looks to be a realistic wish list for 2015. Of course, the proof’s in the pudding. We’ll report back as they hit various milestones.