The FDA recently released the Center for Devices and Radiological Health’s (CDRH) Strategic Priorities guide highlighting the accomplishments they’ve made over the past two years, and more importantly, the main objectives for the years ahead.
We’ve pulled out the three key objectives for 2016 and 2017 from the 12-page paper and summarized them below.
1: Establish a national evaluation system for medical devices
The problem:
The CDRH’s mission to reduce the time and cost of generating evidence has come a long way over the past two years but one crucial step still stands in the way: a National Evaluation System for medical devices.
Simply put, clinical trials are just too expensive and inefficient to give innovators an incentive to study and market their products here in the United States. Limited postmarket surveillance tools like passive reporting keep the CDRH’s hands tied when trying to address safety concerns quickly.
The solution:
Create a national evaluation system for medical devices that calls on “real-world evidence” generated both at healthcare facilities and from patients using monitoring devices at home to support regulatory decision making in both pre- and postmarket situations.
How they plan to achieve it:
• Establish an organizational structure and development of infrastructure for the National Evaluation System.
To put such a system place, the CDRH plans to develop data systems that ensure quality information can pass between existing system and that unique device identifiers (UDI) are routinely added to electronic health information.
In addition, recommendations from stakeholders suggest a future evaluation system would utilize electronic health records, registries, and medical billing claims that incorporate UDIs while integrating national resources like PCORnet, Sentinel, and other national and international registries. It would be operated through a public-private partnership governed by a board of reps from stakeholders in the medical device ecosystem and government.
• Develop a framework for the incorporation of real-world evidence into regulatory decision making.
• Develop real-world evidence education and training for CDRH staff and industry.
• Develop metrics to track progress on building a national medical device evaluation system.
2. Create genuine partnerships with patients
The problem:
Patients are no longer passive bystanders in their health. They actively seek information and engage in disease management and shared decision-making with their health care practitioners. To successfully serve patients, the CDRH must form closer partnerships with patients to monitor how devices are working and where to innovate.
The solution:
Create new mechanisms to facilitate patient participation, advance benefit-risk assessments informed by patient perspectives, and foster earlier access to beneficial new devices that meet patients’ needs.
How they plan to achieve it:
• Create a patient-focused program responsible for developing and coordinating CDRH’s initiatives to advance patient engagement and the science of patient input throughout the total product lifecycle.
• Convene the Patient Engagement Advisory Committee to discuss high priority topics regarding patient input in the total product lifecycle.
• Identify/define the various pre- and postmarket regulatory uses of patient-reported outcome measures (PROMs) and issue a report summarizing current PROM regulatory usage patterns and gaps.
• Work with members of the medical device ecosystem to develop a framework for patient input to inform clinical study design and conduct, with a goal of reducing barriers to patient participation and facilitating recruitment and retention.
• Develop education and training for CDRH staff and industry on the development and use of the science of measuring and communicating patient input throughout the total product lifecycle.
3. Promote a culture of quality and organizational excellence
The problem:
The Quality Management Framework developed in 2013 doesn’t do enough to ensure total confidence in the quality of products and services.
The solution:
Foster a culture focused on quality and customer service to achieve organizational excellence.
How they plan to achieve it:
• Continue to implement the CDRH Quality Management Framework.
• Develop education and training for CDRH staff to facilitate the adoption of practices characteristic of a culture of quality and organizational excellence.
• Conduct a Baldrige Performance Excellence Criteria self-assessment to measure progress towards achieving organizational excellence.
• As part of the Case for Quality, collaborate with members of the medical device ecosystem to identify, develop, and pilot metrics, successful practices, standards, and evaluation tools that will be specific to the medical device industry and focus on assuring product and manufacturing quality.
• Identify external partnerships and mechanisms to support a sustainable, voluntary third party program that will utilize quality metrics, practices, standards, and evaluation tools to assess and promote medical device product and manufacturing quality within industry beyond compliance with regulatory requirements.
• Identify FDA policies and practices that will encourage adoption of metrics, practices, standards and evaluation tools that promote medical device product and manufacturing quality, and recognize efforts to exceed baseline expectations of compliance with regulatory requirements.
To learn more about the Center for Devices and Radiological Health’s Strategic Priorities, including goal dates and references, click here to read the full report.
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