CDRH Announces 2014–2015 Strategic Priorities

February 5, 2014—The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) announced its 2014-2015 Strategic Priorities.

The three priorities are to strengthen the clinical trials enterprise, strike the right balance between premarket and postmarket data collection, and provide excellent customer service.

In accord with the FDA’s mission to protect and promote the public health, these priorities are intended to serve the CDRH’s vision that “patients in the United States have access to high-quality, safe, and effective medical devices of public health importance first in the world.” CDRH stated that the 2014-2015 priorities are critical to reaching this vision.

By addressing these priorities over the next 2 years, CDRH stated that it hopes to help medical device developers see the United States as the country of first choice for their technologies, which is a key contributor to early patient access to high-quality, safe, and effective devices. By providing excellent customer service, CDRH seeks to improve its interactions with stakeholders and colleagues (both internal and external), support better regulatory outcomes, and improve patient health.

CDRH will aim to improve the efficiency, consistency, and predictability of the investigational device exemption (IDE) process to reduce the time and number of cycles needed to reach appropriate IDE full approval for medical devices in general, and for devices of public health importance, in particular.

Noting that in fiscal year (FY) 2013, 45% of IDEs received a full approval decision within two cycles and median time to full IDE approval was 174 days, CDRH’s IDE cycle targets are:

• By September 30, 2014, reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 25% compared to FY 2013 performance.
• By September 30, 2014, for disapproved IDEs, offer all sponsors a teleconference or in-person meeting to occur within 10 business days of the IDE decision.
• By June 30, 2015, reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 50% compared to FY 2013 performance.

The targets related to IDE approval are:

• By September 30, 2014, reduce the overall median time to appropriate full IDE approval by 25% compared to FY 2013 performance.
• By June 30, 2015, reduce the overall median time to full appropriate IDE approval to 30 days.

CDRH will seek to increase the number of early feasibility/first-in-human IDE studies submitted to the FDA and conducted in the United States compared to FY 2013 performance.

To accomplish this, CDRH will:

• The Office of Device Evaluation will establish a premarket clinical trials program responsible for the oversight and performance of the IDE program and the development and implementation of policies that contribute to the timely initiation and successful execution of medical device clinical trials. 
• Formalize the incorporation of CDRH’s benefit-risk framework, including patient-specific factors (eg, tolerance for risk and perspective on benefit), into the IDE process.
• Establish a process to efficiently and objectively resolve application-specific IDE issues to reduce the number of multicycle IDEs.
• Develop a clinical trials education and training program for CDRH review staff, managers, and industry.
• Develop real-time metrics to track CDRH and industry IDE and clinical trial performance.

In order to assure the appropriate balance between premarket and postmarket data requirements to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance, CDRH set the following targets:

• By December 31, 2014, review 50% of device types subject to a premarket approval (PMA) that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.
• By June 30, 2015, review 75% of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.
• By December 31, 2015, review 100% of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.

To accomplish this goal, CDRH will take several actions including the following:

• Develop and seek public comment on a framework for when it is appropriate to shift premarket data collection to the postmarket setting.
• Conduct a retrospective review of all PMA device types to determine whether or not to shift some premarket data requirements to the postmarket setting or to down classify device types in light of CDRH’s current understanding of the technology.
• Implement a mechanism to prospectively assure the appropriate balance of premarket and postmarket data requirements for new devices subject to a PMA.
• Using existing authorities, develop and seek public comment on a new pathway to market for devices subject to a PMA that address an unmet public health need by shifting appropriate premarket data needs to the postmarket setting and incorporating features of the Innovation Pathway pilots.

Targets for providing excellent customer service are:

• By December 31, 2014, achieve at least 70% customer satisfaction.
• By June 30, 2015, achieve at least 80% customer satisfaction.
• By December 31, 2015, achieve at least 90% customer satisfaction.

To accomplish excellent customer service, CDRH will:

• Implement Customer Service Standards to promote excellent customer service.
• Assess customer satisfaction using a standardized survey tool embedded in emails and available on its website.
• Establish a CDRH program to monitor and address feedback on CDRH processes and services and improve quality and performance that includes corrective action and preventative action processes.
• Implement the principles and practices outlined in the CDRH Quality Management Framework to improve the quality and performance of CDRH processes and services.