Over the past five years, the Food and Drug Administration’s device program has shown a pattern of markedly improved performance. Today it is performing strongly across a wide range of performance measures. At the same time, FDA has implemented a range of initiatives to promote access to safe and effective medical devices for American patients.
These improvements include those to 510(k) and premarket approval (PMA) review times along with a reduction in Investigational Device Exemption (IDE) review times of almost a full year-which means many devices investigated in the United States now reach the market a full year sooner than they did at the beginning of this decade. Performance in FDA’s review of novel, moderate risk devices has also improved markedly, demonstrating the success of FDA’s efforts to expand use of its de novo review pathway.
Importantly, these advances in the performance of the device program reflect a combination of programmatic improvements and innovative approaches to applying existing authorities, rather than changes to the basic framework for device oversight that was put in place almost 40 years ago. The existing framework assures that FDA’s level of oversight matches the level of device risk, and applies flexible standards to premarket review of devices without compromising the standard for safety and effectiveness of devices. Enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) and increased Medical Device User Fee Act (MDUFA) funding facilitated some of the performance improvements in the device program. But neither FDASIA nor MDUFA altered the fundamental components of FDA’s flexible, risk-based framework for device oversight.
Recent programmatic improvements and policy changes implemented by FDA, on its own initiative, include:
- Implementing a clinical trials program, dramatically improving its performance in reviewing clinical investigations of devices and building on the device program’s longstanding interest in encouraging the use of innovative methodologies and study designs, such as the use of adaptive trial designs, where appropriate. This program has shown early success by encouraging companies to initiate early feasibility studies of devices in the United States, a development that can be expected to result in earlier access to those devices for American patients.
- Recalibrating the benefit-risk framework used in premarket review of devices and developing several new policies to include patient preferences in evaluating the risks and benefits of a device and speed access to devices with important benefits for American patients who have few options.
- Co-founding a public-private partnership and implementing new policies to promote the development and qualification of regulatory science tools and real world evidence for use in device development and assessment, as well as surveillance of the real world performance of medical devices.
- Adapting premarket and postmarket oversight to keep pace with rapidly evolving new technologies, including mobile medical apps and other health information technology (IT), companion diagnostics, and next generation sequencing tests.
This paper discusses these initiatives and shows how FDA’s device program has adapted to changes in the marketplace, scientific advances, and new technology-all under the existing flexible, risk-based framework for oversight of medical devices. This framework continues to serve the American public well by promoting access to devices of public health importance, while protecting American patients from devices that are unsafe or ineffective.