The U.S. Food and Drug Administration (FDA) has issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices: foster device innovation, create a more predictable regulatory environment, and enhance device safety. These evaluations are the result of concerns that have been raised both inside and outside the FDA about whether the current 510(k) program achieves its goals of making safe and effective devices available to the public while fostering innovation. The FDA’s Center for Devices and Radiological Health (CDRH) is seeking to strike the right balance between the ability to adapt its approach as new science emerges and to provide predictable regulatory pathways.
The CDRH assessment consists of two preliminary reports that overlap in several places and cross-reference information. One report focuses on ways to strengthen and clarify a premarket review process called the 510(k) program for medical devices that do not need to undergo a full premarket approval review. The other evaluates CDRH’s use of science in decision-making, with an eye toward adapting to new scientific information, while maintaining regulatory predictability necessary for innovation.
“These preliminary reports show…an agency [FDA] that recognizes both sides of our mission to protect and promote public health,” said CDRH Director Jeffrey Shuren, MD. “The agency is ready to make necessary improvements to support device innovation while assuring patients receive safe and effective devices.”
Selected recommendations and the key public health objectives they address include the following:
Fostering Device Innovation
- The 510(k) report recommends major improvements to the regulatory pathway for lower-risk novel devices that cannot be cleared through 510(k) but do not warrant the more rigorous premarket approval review applied to higher-risk devices.
- The science report recommends that CDRH make better use of scientific experts outside of the agency by developing a web-based network of external experts using social media technology.
Enhancing Regulatory Predictability
- The 510(k) report recommends that CDRH develop a guidance document defining a subset of moderate-risk (Class II) devices, called Class IIb, for which clinical or manufacturing data typically would be necessary to support a substantial equivalence determination.
- The science report recommends use of a standardized “Notice to Industry” letter that would generally be issued as a “Level 1 – Immediately in Effect” guidance document to quickly communicate when CDRH has changed its premarket regulatory expectations due to scientific information that has emerged about a certain device type.
Improving Patient Safety
- The 510(k) report recommends that CDRH consider revising regulations to explicitly require 510(k) submitters to provide a summary of all scientific information known or that the submitter should reasonably know regarding the safety and effectiveness of the device under review.
- The 510(k) report recommends that CDRH develop a guidance document that clarifies when a device should not be used as a predicate, such as when the device has been removed from the market because of safety concerns. The report also recommends that the center consider issuing a regulation that would clarify the circumstances under which the center would exercise its authority to rescind a 510(k) clearance to remove an unsafe device from the market and preclude its use as a predicate and also consider whether additional authority is needed.
- Both reports recommend that CDRH build upon public databases to include meaningful, current information that supports good decision making and promotes the safe use of devices. In addition, the science report recommends that CDRH build upon the existing transparency website to provide more immediate information on how devices are regulated.
For more information see CDRH Preliminary Internal Evaluations and CDRH Device Approvals and Clearances: 510(k) Clearances.
Editor’s note: For more information on this subject, read “The Looming Giant: The FDA’s Evolving Role in O&P,” in the September 2010 issue of The O&P Edge.