Jun 2, 2021

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is seeking stakeholder input regarding proposals for improved labeling for some implantable medical devices and their materials.

The CDRH request for comment coincides with a new discussion paper, Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework, proposes developing a framework for including data on specific materials in the labeling of medical devices such as breast implants and metal-on-metal hip implants that entail long-term exposure (30 days or more) for patients. Including material composition data in device labeling would facilitate more informed decisions by healthcare providers and patients in terms of safety and risk, according to the paper.

Metal components and biocompatibility concerns

FDA’s latest discussion paper follows efforts the agency undertook over the past several years to address safety and health concerns associated with certain implantable devices incorporating metal components that could trigger adverse biological responses in patients.

Previous activities included post-market reviews of medical implants with metal components; a discussion paper on the agency’s analysis of biological responses to metal-based implants; and an Immunology Devices Panel advisory meeting to identify gaps in FDA’s understanding of potentially adverse immunological responses to implants incorporating metal materials.

Current FDA research efforts

Ongoing research efforts FDA has undertaken are intended to address gaps in understanding of how metal-based medical implants may adversely affect some patients, and will inform agency plans to revise requirements for labeling and product information disclosure to healthcare providers and patients.

FDA researchers are focusing on issues including:

  • The scope and frequency of adverse health events and outcomes involving metal implants
  • Which in vitro tests and safety limits for metal corrosion and wear may be clinically relevant
  • Effects of anatomical location as well as device characteristics on patients’ immune responses
  • Appropriate biomarkers for screening and monitoring of patients with metal implants

Based on the outcomes of these research efforts, the agency expects to develop improved premarket evaluations of medical implants, more effective screening and monitoring of patients as well as safer product designs for metal implants.

FDA and CDRH will accept stakeholder input through July 19, 2021.

Learn more about US FDA medical device regulations at Emergo by UL:

  • FDA 510(k) premarket notification consulting for medical device and IVD companies
  • FDA medical device classification consulting
  • Whitepaper: ISO 10993-1 and biocompatibility for medical devices

 

Author

  • Stewart Eisenhart

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