FDA issues new guidance on accounting for health care noncompliance when reviewing proposed devices

On October 21, the US Food and Drug Administration (FDA) published draft guidance that, if finalized, would update the agency’s 2018 guidance on its piercer program (the “Program”). In the draft guidance, FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a device will help address health care disparities and promote health care equity. In other words, FDA intends to specifically consider whether a device can provide more effective treatment or diagnosis in populations affected by health and/or health care disparities when determining eligibility for breakthrough status.

The Breakthrough Devices program was launched in 2018 to provide patients and healthcare professionals with faster and easier access to medical devices that effectively diagnose and treat life-threatening or irreversibly disabling diseases or conditions. This program allows the FDA to expedite product development, evaluation, and review while maintaining statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization. If this final draft guidance is finalized after a public comment period, the agency will incorporate the proposed language into the 2018 guidance.

To address health care disparities, FDA is proposing to add a new section III.B.3.d to the 2018 guidance that recognizes the urgent public health need for innovative technologies that help reduce barriers to achieving of health equity and help improve health outcomes across populations. . The new section will recognize that “[a]Addressing health and health care disparities is important not only to achieve health equity, but also to improve overall quality of life and health outcomes for all patients.” Thus, it is suggested that consideration should be given to whether a device “is intended to address a pathophysiological or clinical feature associated with certain populations that may have a clinically relevant impact on the treatment or diagnosis of the condition in those populations’. If so, the device may be “considered reasonably expected to offer a more effective treatment or diagnosis” and therefore may qualify for breakthrough status. The FDA claims that the proposed changes “may accelerate the availability of certain devices that meet statutory designation criteria and benefit populations affected by health and/or health care disparities, thereby promoting and advancing health care equity.”

In addition to the health disparities considerations, FDA proposed the following other changes to the 2018 guidance:

  • IN Introductioncertain non-addictive medical products for the treatment of pain or addiction may not be eligible for the Breakthrough Devices program.
  • Section III.B.1 Determination Considerations will have added language stating that the FDA will “review all information about a proposed device, including its function, potential for technical success, potential for clinical success, potential for clinically significant impact, and its potential benefits and risks when evaluating whether the device is reasonably expected to provide more effective treatment or diagnosis”
  • The last section receiving updates is Section III.C Designation Review Process which will describe when FDA may publicly disclose designation requests that have been “previously publicly disclosed or acknowledged by the sponsor of the breakthrough device designation request” and will publicly disclose its breakthrough device designation status for its intended use.

FDA will accept comments on the draft guidance until December 18, 2022.

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