For quite some time we’ve watched the blame for slow review times pass between industry and FDA. One side claims the pathway to approval lacks transparency and predictability, the other claims the submissions are of poor quality. But could this coming year be the start of a new relationship between FDA and industry?
Recently an article was posted in MD+DI which examines the question, “CDRH Says It has Improved Its Processes, Do you Agree?” This question prompts a review of those items CDRH listed as priorities; for reference, the priorities include:
- 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.
For more information on the CDRH’s 2013 Strategic Priorities which “aims to reset the direction of CDRH toward smart regulation.” In fact, you can check out the report published “Improvements in Device review.” However, as strongly put in the MD+DI article, “Better than glossy reports is more meaningful transparency from the center.”
What are your thoughts on the processes of CDRH? Do you think the six priorities listed above hit the mark for industry and patients? Share your opinions below.
Photo Credit: Sebastian.YEPES