With this year coming to an end it’s time to look back and review the past year and start making the “to-do” list for the upcoming year. FDA has already taken this initiative and recently posted their Strategic Priorities for 2013. We’ve summarized the priorities and the planned steps to complete these proposals.
- Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world.
- To successfully reach this goal, CDRH plans to strengthen the pre-market review program, strengthen and streamline the clinical trial enterprise, strengthen the regulatory pathway from product conception to patient access. This will all be balanced with the science based-decision making to provide industry with predictable pathways for approval.
- The U.S. is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety.
- This will be accomplished be strengthening our national regulatory science infrastructure. CDRH will also issue guidance on the benefits of medical imaging exams while minimizing the risks to help assure that patients will get the right imaging exam.
- U.S. post-market surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance.
- Plans are in the works to enhance post-market tools and implement new initiatives for post-market surveillance. Also the goal is to implement a comprehensive strategy to assess real world device performance.
- Devices are legally marketed in the U.S. and remain safe, effective, and of high-quality.
- CDRH plans to create policies that go beyond compliance with regulations to a stronger focus on quality device manufacturing. The Agency also plans to establish a voluntary compliance improvement pilot program and also address challenges associated with globalization.
- Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make health care decisions.
- By improving the accessibility and usefulness of devices labeling this will provide the information needed to understand and assure safe and effective use of medical devices.
- Strengthen Our Workforce and Workplace
- This will hopefully be accomplished by implementing a plan of action to address the recommendations from employees and provide a workplace within CDRH that promotes productivity and satisfaction.
CDRH makes it clear that patients are the main focus of CDRH. Will this rough blueprint allow for the Agency to best meet the needs of patients and satisfy the industry? What would you like to add to the list? Comment below.
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