FDA Drafts Strategy to Improve Device Approvals

Capping a year-long process wracked by controversy, criticism and concern, the U.S. Food and Drug Administration (FDA) has created a preliminary but detailed plan to better regulate the nation’s medical device industry.

A 172-page report released last week contains recommendations to help the agency achieve three main objectives: foster device innovation, create a predictable regulatory environment, and enhance device safety. “By increasing the predictability, reliability, and efficiency of our regulatory pathways, we can help provide better treatments and diagnostics to patients more quickly, stimulate investment in and development of promising new technologies to meet critical public health needs, and increase the global market position of U.S. medical devices,” Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health (CDRH), wrote in the foreword to the two-volume report.

The recommendations contained in the FDA’s report were driven by an internal reassessment of the agency’s premarket review process, otherwise known as the 510(k) program. Last year, the program was criticized by public health advocates and lawmakers as well as CDRH scientists who claimed they were pressured to approve certain products.

The FDA uses its 510(k) program to grant speedy approval to medical devices that are deemed similar to products already on the market. Manufacturers are partial to the program because it provides them with a cheaper, faster path to product approval. In recent years, however, concerns have been raised about the 510(k) process, specifically whether it allows medical devices to enter the market without sufficient safety and effectiveness evidence and whether a lack of predictability, consistency and transparency hinders device development.

Last year’s criticism about its device approval process prompted the FDA to create two panels to review the 510(k) program and recommend changes. The recommendations from those panels—the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making—are the result of input from public meetings, open dockets, data analyses and input from CDRH staff.

The preliminary reports are available for public comment and review at www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm220272.htm. Once the CDRH has assessed public input, it will announce which recommendations it will adopt, along with projected timelines for doing so, according to a news release from the FDA.

Some of the key recommendations and the public health objectives they address include:

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 which do not warrant the more rigorous premarket approval review applied to higher-risk devices. The report calls for major reforms in the implementation of this process—called the de novo classification process. The recommendations include streamlining the process and clarification of CDRH’s expectations for submissions that undergo this type of review.

•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. This network would help CDRH staff leverage outside knowledge without serving in an advisory capacity.

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. This guidance document would help clarify what information submitters should include in their 510(k) submissions so that they can plan accordingly. In addition, this would also help the center’s review staff obtain the type and level of evidence necessary to make well-supported decisions without as much need for time-consuming follow-up requests for information.

•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. CDRH currently communicates this kind of information through individual interactions during the review process, which can lead to delays. These letters would provide greater clarity to affected manufacturers, in a timelier manner, about CDRH’s expectations with respect to a particular group of devices.

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. This is not required now for 510(k) submissions and, as a result, relevant information may not be included in an initial submission. This summary would help CDRH review staff to more efficiently make decisions, and potentially avoid extensive follow-up inquiries and questions.

•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, up-to-date information that supports good decision making and promotes the safe use of devices. This could be accomplished by improving the current 510(k) database so that it includes summaries of FDA review decisions, current labeling and photos. In addition, the science report recommends that CDRH build upon the existing transparency website to provide more immediate information on how devices are regulated.