CDRH To Review Materials Used In Medical Devices

Maryland, 18 March 2019: Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren on Friday announced plans to improve the agency’s approach to evaluating material safety and biocompatibility.

“Modernizing the regulatory framework pertaining to the FDA’s review of medical device materials requires a multi-step approach. We’ll gather input from patients, device manufacturers, researchers and physicians to learn more about their concerns and ideas for how the FDA should proceed,” Gottlieb and Shuren said.

According to Gottlieb and Shuren, most patients with implanted medical devices do not experience any adverse reactions, but “a growing body of evidence suggests that a smaller number of patients may have biological responses to certain types of materials in implantable or insertable devices.”

These reactions include inflammatory reactions and tissue changes that can cause pain, fatigue, rashes and other health issues for affected patients. In the case of textured breast implants, FDA has found higher rates of anaplastic large cell lymphoma in patients with textured breast implants compared to smooth-surface breast implants.

While FDA already evaluates the materials used in implantable and insertable devices, Gottlieb and Shuren said the agency is looking for ways to enhance these evaluations beyond the recommendations made in a 2016 guidance on biocompatibility evaluations.

“While such testing generally has been a reliable predictor of a material’s safety, we also recognize the importance of advancing the science we rely on to evaluate device materials and patient risk factors both before and after devices enter the market,” Gottlieb and Shuren said.

To advance these efforts, Gottlieb and Shuren said that FDA will host an advisory committee meeting on nitinol and other metals used in implantable devices to investigate the risk of patients developing hypersensitivity to those materials. Next week, the agency’s General and Plastic Surgery Devices advisory committee is also meeting for two days, in part to discuss the risk of lymphoma from textured breast implants.

Additionally, Gottlieb and Shuren say that CDRH’s Office of Science and Engineering Laboratories (OSEL) is carrying out research into new types of materials, such as graphene, to determine how these materials interact with the immune system or cause other toxicities in anticipation of their use in future devices.

The two also point to the agency’s efforts to implement the National Evaluation System for health Technology (NEST), which they say will improve the agency’s use of real-world evidence to identify device safety issues.Regulatory Focus