CDRH seeks feedback on proposed materials labeling framework

Regulatory NewsRegulatory News | 24 May 2021 |  By 

The US Food and Drug Administration (FDA) is asking stakeholders for comment on how it should communicate information about materials contained in medical devices to healthcare providers and the public.
FDA’s Center for Devices and Radiological Health (CDRH) recently published a discussion paper, titled, “Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework,” that is intended to facilitate discussion and feedback about how FDA would communicate that information to stakeholders.
“The release of this subsequent discussion paper is intended to foster discussion and solicit feedback from stakeholders, including patients, on how we can ensure patients and healthcare providers have access to more comprehensive information about the different materials used in and on devices. This will help to ensure that patients and providers are empowered to make well-informed decisions about whether or not an individual should use a particular medical device,” Jeff Shuren, MD, JD, CDRH director, said in an announcement.  
In 2019, CDRH held an Immunology Devices Panel of the Medical Devices Advisory Committee meeting that focused mainly on immunological reactions to metal-containing medical devices. The discussion paper followed the advisory committee meeting as well as years of high-profile safety concerns with several kinds of medical devices and how long-term exposure to these devices can result in adverse events for patients. Safety issues surrounding certain brands of breast implants, metal-on-metal hip replacements, and permanent birth control for women prompted FDA’s CDRH to consider “a broader approach to materials safety and evaluation, so as not to limit such evaluation to a single type of material.” (RELATED: “FDA: Nearly All Essure Devices Returned to Bayer, Enrollment in Postmarket Study Complete” Regulatory Focus 10 January 2020)
“The discussion paper is a direct result of the information we received from the November 2019 advisory committee meeting,” Shuren said. “Our request for public feedback underscores the value we place on obtaining insight from stakeholders to help inform and shape our decision-making.”
Based on that meeting, FDA said stakeholders are interested in “medical device materials and their impact on the benefits and risks of medical devices,” specifically more detail on materials in devices that are in contact with tissue and for devices used repeatedly. CDRH highlighted several factors they considered important for healthcare providers and patients to make informed decisions on device use, including duration of implantation, duration of contact, usefulness of labeling, and diversity of devices. The center is also requesting feedback on what information should be present on healthcare provider and patient labeling and the format of those materials.
Where materials such as metals, ceramics, and polymers are referenced in labeling CDRH is requesting feedback on possible naming conventions and other labeling considerations, which can include listing trace elements, toxicology risks, polymer composition, and detailing chemical names of processing reagents in animal- and non-animal-derived materials.
CDRH posed two specific questions to stakeholders: how should they consider specific important and relevant materials information for a labeling framework to be given to patients and providers; and which of the “the wide range of devices in use” should have this detailed materials information?
“CDRH recognizes that we are in an era of device and materials innovation, which has led to technological breakthroughs which have greatly improved patients’ lives,” the authors of the discussion paper wrote. “We also recognize the great level of scope and complexity of materials utilized in medical devices, which can be challenging to communicate in a clear and consistent manner.”
“The FDA is pleased to be at the forefront supporting this era of medical device innovation while maintaining patient safety. We know that both work in tandem to bring access to safe and effective medical devices. Ultimately, this increase in transparency aims to minimize the potential for patient risk and have a profound impact on patient health and quality of life,” Shuren said.


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Tags: CDRH, devices, FDA, US

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