Winston Churchill said that “Democracy is the worst form of government except all the others that have been tried.” Similar arguments have been made by most constituents in the Medical Device ecosystem about the 510(k) process. Seeking ways to improve the 510(k) process the FDA’s Center for Devices and Radiological Health (CDRH) commissioned the Institute of Medicine (IOM) to evaluate and provide recommendations for improving this process.
On July 29, 2011, the IOM released its long awaited report on FDA’s 510(k) clearance process. The concludes that “the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM recommends that the “FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the Device Life Cycle.”
The response from both FDA and industry was swift and direct. Although all seem to agree that the 510(k) process needs to be improved neither the FDA nor industry stakeholders are willing to start from scratch to implement them.
Jeffrey Shuren, MD, Director of CDRH, noted that: “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs.”
Comments from industry groups were more forceful in their disapproval of the IOM report recommendation. Medical Device Manufacturers Association (MDMA) President and CEO Mark Leahey stated in part “…we completely disagree that the 510(k) pathway is ‘flawed’ and that the FDA needs to eliminate it. While we are pleased that the IOM recognizes the crucial role medical devices have in health care, it is also important to remember that studies prove the 510(k) process has a strong track record on patient safety, and a complete overhaul of the system is simply not warranted.”
Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed) was more specific in his statement: “The report’s conclusions do not deserve serious consideration from the Congress or the Administration. It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure. This would be a disservice to patients and the public health.”
Where do we go from here?
Most constituents agree that improvements to the current 510(k) process are needed.
IOM’s recommendations for the “Ideal Medical-Device Regulatory System” are a worthy goal to strive for. The IOM committee defined the following six attributes of an Ideal Medical-Device Regulatory System (not presented in any priority order)
- The process should be based on sound science.
- The process should be clear, predictable, straightforward, and fair.
- The process should be self-sustaining and self-improving.
- The process should facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their Life Cycle.
- The process should use relevant and appropriate regulatory authorities and standards throughout the Life Cycle of devices to ensure safety and effectiveness.
- The process should be risk-based.
The IOM’s proposed “approach” for the Ideal Medical-Device Regulatory System sounds a lot like FDA’s Total Product Life Cycle approach. The Top priority in CDRH’s 2011 Strategy is the full implementation of a Total Product Life Cycle approach. To support this effort, The Agency plans to integrate premarket, postmarket, and compliance information and functions to take into consideration all of the relevant information available to the Center at any stage of a product’s Life Cycle to assure the safety, efficacy, and quality of medical devices. (See: Is Industry Ready To Meet FDA CDRH Top Strategic Priority)
FDA’s 5 year plan further asserts its commitment to a Life Cycle approach. To this end, FDA is working to take steps to facilitate the seamless incorporation of new scientific information available throughout the Total Product Life Cycle into regulatory decision making.
So rather than throwing out the baby with the bathwater, I would suggest that all constituents collaborate to improve the 510(k) process to:
- Provide reasonable assurance that marketed devices, throughout their Life Cycles, are safe and effective according to current standards for the clinical indication at the time of use.
- Facilitate innovation by allowing prompt access of devices to the market.