CDRH Releases 2012 Strategic Priorities, Looks to Boost Innovation With New Regulatory Pathway and Regulatory Science
Posted 24 January 2012 | By
The US Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) released their strategic priorities for the coming year on 24 January 2012. The priorities consist of four main strategies and corresponding implementation goals, and includes several new and important initiatives.
CDRH's first strategy is to "fully implement a total product life cycle approach to product regulation that takes "into consideration all of the relevant information available to the Center" at "any stage of a product's life cycle."
To accomplish this, CDRH plans to:
- Strengthen premarket review by starting a Triage of Pre-market Submissions Pilot to speed up approvals and better manage CDRH's workload, clarify CDRH's thinking regarding clinical trials conducted outside of the US, finalize all guidance documents related to the premarket program, evaluate CDRH staffing and policies, and generate rules for all Class II pre-amendment medical devices
- Address challenges associated with globalization by holding the first meeting of the International Medical Device Regulators Forum (IDMRF) and participate in at least two harmonization activities with foreign regulatory authorities
- Enhance compliance capability by promoting best-quality manufacturing practices, increase transparency of device quality data and the recall process, develop methods and procedures to better analyze recall information and generate criteria for terminating recalls
- Enhance collaboration through reorganization by continuing plans to better integrate staff functions and communication
- Implement a knowledge management strategic plan to make the best use of information collected or developed by CDRH
- Assess real world device performance by generating a proposed strategy and calling for public input
- Enhance CDRH's quality assurance program to include periodic auditing of CDRH's regulatory programs
CDRH's second strategy is to "enhance communication and transparency" in order to improve public health and generate constituent trust. CDRH plans to distribute information in a timelier manner, and by December 2012 start the development of a "national forum" to engage patient, consumers and healthcare professionals. CDRH also hopes to improve internal communications by issuing new SOP's for sharing information between CDRH staff and make general improvements.
CDRH's third strategy is to strengthen staff through a new Experiential Learning Program (ELP) and Leadership Enhancement and Development Program (LEAD) that should be fully implemented by the end of 2012. The agency is further looking to develop ways to recognize good employee performance and "address poor performance" in the agency.
The agency's fourth and final priority is to "facilitate innovation" to "address unmet public health needs." CDRH plans to do this by creating tools to improve the innovative products pipeline with the use of their Entrepreneurs in Residence Program and the piloting of a new Innovation Pathway 2.0. CDRH is further looking to develop guidance on companion diagnostics, draft guidance on co-development of drugs and biologics and devices, and new partnerships and virtual computer models to boost regulatory science.