Report at a Glance
The Medical Device Regulatory System
The 510(k) process does not operate in isolation. Premarket review, including the 510(k) process, and postmarket oversight—from product labeling regulations to the reporting of adverse events associated with use of a device—make up a comprehensive medical device regulatory system. All the components of the system need to be functioning well in order to provide a reasonable assurance of the safety and effectiveness of medical devices.
No premarket regulatory system for medical devices can guarantee that all new medical devices will be completely safe and effective when they reach the market. Robust postmarketing surveillance is essential. The committee identified substantial problems in the current postmarketing surveillance of devices. The FDA should develop and implement a comprehensive strategy to collect, analyze, and act on medical device aftermarket performance information.
It is important for the FDA to use postmarket enforcement tools, such as seizing or banning a device, when necessary. The FDA has stated that there are limitations to the use of these tools but has not identified the limitations. The agency should review its postmarket regulatory powers to identify these limitations and address them.
The committee recommends that the FDA develop and implement a program of continuous quality improvement to increase predictability, transparency, and consistency in all regulatory decisions for devices and to address emerging issues that affect decision making.
The committee finds 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 committee concludes 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. This new framework should:
- be based on sound science;
- be clear, predictable, straightforward, and fair;
- be self-sustaining and self-improving;
- facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their lifecycle;
- use relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and effectiveness; and
- be risk-based.
Current information is not adequate to design a new framework, and the FDA should begin to obtain the needed information. Once adequate information is available to design an appropriate medical-device regulatory framework, Congress should enact legislation to do so. A new regulatory framework will benefit everyone—patients, healthcare providers, the medical device industry, payers, and the FDA.