The Center for Devices and Radiological Health (CDRH) recently released an update on its 2014-2015 Strategic Priorities. This document summarizes the areas that CDRH is focusing on to ensure patients in the US have access to high-quality, safe, and effective medical devices. The current strategic priorities are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection, and to provide excellent customer service.
To strengthen the clinical trial enterprise, CDRH focuses on the efficiency and cost-effective nature of their activities while ensuring proper patient protections. Specific areas of development include:
- Defining a Clinical Trials Program that contributes to the timely initiation and execution medical device clinical trials
- Creating comprehensive Education and Training for CDRH staff
- Formalizing a Benefit-Risk Framework for IDEs, with a draft guidance document expected in 2015
- Establishing a process to reduce the number of Multi-Cycle IDEs
- Forming real-time metrics to track CDRH and industry clinical trial performance
The right balance between premarket and postmarket data is of significant concern to efficiently bring high-quality, safe, and effective medical devices to patients through a total life cycle approach. Specific areas of development include:
- Balancing premarket and postmarket data collection, draft guidance released in 2014
- Retrospective review of all PMAs and potential reclassification of device types
- Expediting access PMAs (EAP), draft guidance released in 2014
CDRH also understands that excellent customer service results in better regulatory outcomes and supports improvements to patient health. These areas of development are:
- Implementing a Customer Service Standards of Excellence
- Providing a Customer Service Survey, available on the CDRH website
- Establishing a FEEDBACK√CDRH Program to collect, monitor, and address feedback received from staff and external stakeholders
- Incorporating Quality Management Framework
More detailed information can be found within the Strategic Priorities document. This document is an example of transparency and accountability by CDRH and the FDA and is important for the CDRH organization and external stakeholders. It behooves industry professionals to understand the current FDA thinking on key topics that could have impacts on future study design, premarket and postmarket data collection, and device classification. The improvements in process time for applications and subsequent communication creates a more efficient approval process for device companies and the ultimate benefactor – the patient.
What upcoming draft or final guidance documents will have the greatest impact within the medical device field? Share your thoughts below!
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