The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) is hailing its own performance in regulating the development of medical devices in the United States, saying in a new report that it has reduced review times and is helping to bring safe products “to market more quickly.” In fact, the agency says it has reduced review times for some devices by “almost a full year” and is making decisions on submissions more quickly.
“Over the past five years, the Food and Drug Administration’s device program has shown a pattern of markedly improved performance,” the agency asserts in the report, FDA’s Role in Ensuring American Patients Have Access to Safe and Effective Medical Technology. “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.”
The report, released in mid-August by the agency, comes after years of often tough criticism-especially in the early part of this decade-by medical devices manufacturers who said the regulatory review process was slow, confusing, and driving companies overseas. At the same time, the FDA has also come under fire from some patient advocacy groups who say its oversight has not been strong enough. Over the past several years, the agency has instituted a number of changes that it says address both concerns, “striking the right balance.”
In doing so, the agency says it stayed true to its basic framework, one that allows for flexibility and recognizes that the FDA’s mandate has never been to “eliminate risk” when it comes to medical devices. “Rather, FDA applies only the level of oversight necessary to establish a reasonable assurance of safety and effectiveness of devices,” the agency says in the report.
Specific improvements cited in the report include the following:
• The implementation of a clinical trials program to coordinate oversight of clinical studies of medical devices. The agency says it is making better use of statistical methods that allow for “shorter and smaller clinical trials.”
•A recalibration of the benefit-risk framework for the premarket review of devices, one that incorporates “patient preferences in evaluating the risks and benefits of a device.”
•Collaboration with others in the public and private sectors to promote the development 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.”
•A commitment to oversight that keeps pace with “rapidly evolving new technologies, including mobile medical apps and other health information technology (IT), companion diagnostics, and next generation sequencing tests.”
In detailing its performance on review times, the agency cites several examples. One of them deals with 510(k) submissions, which refer to a type of application dealing with Class II and Class I medical devices, moderate and low-risk categories respectively. “In fiscal year (FY) 2010, it took 132 days for a total time to a decision on a 510(k),” the report says. “By FY 2014, total time had dropped by 13 percent to about 115 days.”