5 years of improvement for FDA’s medical device program

Medical device technology is advancing at a rapid pace. New devices improve on the technology of existing devices to make less invasive treatments possible, provide new options to patients whose conditions would have been considered untreatable in the past, and create technologies that will be keystones in precision medicine and other emerging fields. The FDA is responsible for facilitating device innovation and patient access to new medical technology and also must provide the oversight to minimize risks and ensure that devices provide clinical benefits. Since 2010, the agency has improved Americans’ access to safe and effective medical devices, approving new devices in less time than in the past. A report titled “FDA’s Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology” shows marked improvement in all areas of device review, which the report attributes to a combination of programmatic improvements and innovative approaches to applying existing authorities.

Device oversight framework

The Medical Device Amendments of 1976 (MDA) (P.L. 94-295) established a flexible framework for the FDA’s oversight of medical devices. The legislation required the agency to tailor its oversight of devices to the degree of risk presented. Although medical devices inherently carry risk, the MDA did not require the FDA to eliminate all risks, but instead to establish a reasonable assurance of safety and effectiveness.

For premarket review of devices, which applies to about half of all devices, the FDA’s evidentiary standard is valid scientific evidence. This assures that the evidence is of sufficient quality that it can be relied on to determine whether or not a device should be approved or cleared.

The flexible approach created by the MDA provides the FDA with tools to assure safety and effectiveness of devices. It also allows the agency to adapt its oversight as medical technology advances.

FDA oversight adaptations

According to the report, the FDA has implemented new policies and programmatic changes in the past five years that respond to the needs of American patients. These adaptations ensure that Americans have timely access to high-quality, safe, and effective devices, and also respond to new challenges created by rapidly evolving fields of medical innovation. The initiatives include the following.

  • Streamlining clinical trials. The FDA established a Clinical Trials Program to coordinate its oversight of clinical studies of devices, provide interventions if an application review takes too much time, offer more opportunities for interactions with sponsors, expand training for review staff, and establish new or modified policies in this area.
  • Flexible decision making. The FDA implemented a series of new premarket policies that build on the MDA’s risk-based framework. Many of the policies affect important review decisions and impact public health by speeding access to new safe and effective devices.
  • Regulatory science programs. The FDA invested in several new regulatory science programs to reduce the time and cost, but not quality, of data development for devices. These programs promote the development and use of tools, analytical methods, and data sources in premarket applications to bring safe and effective devices to market faster and at less cost.
  • Adapting to new technology. The FDA device program has adapted to new technologies, focusing its oversight efforts on medical devices that present greater risks, with the goal of permitting access to a range of products while ensuring the safety and effectiveness of a subset of mobile medical apps that present greater risk to patients if they do not work as intended.

Results

Thanks to the adaptations and changes implemented by the FDA in the past five years, the following improvements are quantified in the report:

  • significant decreases in time to decision for premarket submissions;
  • a higher percentage of cleared and approved submissions;
  • decreases in the number of pending submissions at the end of a year; and
  • improved customer satisfaction.