FDA Proposes Select Updates to the Breakthrough Devices Program Designed to Reduce Health Care Disparities

October 31, 2022By McKenzie E. Cato

On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care.  This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document.

FDA intends to incorporate these updates into the December 2018 Breakthrough Devices Program guidance after considering public comment.  The proposed updates are designed to clarify how the Breakthrough Devices Program may be applicable to devices “that benefit populations impacted by health and/or health care disparities.”

First, FDA is proposing to add a statement to the introduction section of the 2018 guidance that certain “non-addictive medical products to treat pain or addiction” may be eligible for breakthrough designation.  The draft guidance states that this addition is consistent with FDA’s obligations under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which required FDA to update existing guidance documents to address how the Agency may apply breakthrough criteria to such products.

FDA is also proposing updates to Section III of the 2018 Breakthrough Devices Program guidance to clarify the designation considerations for the first breakthrough criterion—whether a device provides for “more effective” treatment or diagnosis.

Specifically, FDA proposes to add language stating that the level of evidence required to demonstrate “more effective” treatment or diagnosis may vary depending on the intended use of the device, its technology and features, and the available standard of care alternatives.  For this reason, FDA intends to consider the totality of the information about the proposed device, its function, potential for technical success, potential for clinical success, potential for a clinically meaningful impact, and its potential benefits and risks.

This first criterion, requiring a demonstration of “a reasonable expectation that the device may provide for more effective treatment or diagnosis as compared to the current standard of care” is often cited in decisions denying breakthrough designation.  It is not always clear to sponsors of breakthrough designation requests the level of evidence required to meet this standard.  For some devices, preclinical data may be sufficient, while for other devices, FDA may request a clinical study validating the technology.  The language that FDA is proposing to add to the 2018 guidance seems to further reinforce that the level of evidence require will vary widely, and therefore may be difficult to predict, though the new language does not appear to change the “reasonable expectation” standard.

The most significant proposed update is the addition of a new section to the 2018 guidance on reducing disparities in health and health care.  This section notes that, when FDA assesses the statutory eligibility criteria for breakthrough designation, it intends to consider technologies and device features that may help to address health and/or health care disparities and promote health equity by providing for more effective treatment or diagnosis in populations that exhibit health and health care disparities.

Such technologies and features may include those tailored to better address characteristic differences (e.g., those arising from social factors, phenotypic variations, pathophysiology, and/or response to treatment) compared to standard of care.  FDA also intends to consider devices that address disparities that arise in populations impacted by rare diseases or conditions with limited diagnostic and treatment options.

Additionally, FDA plans to consider “accessibility” to health care, which is described as an individual’s or group’s capacity to benefit from a medical device.  Features that may improve accessibility include user features that make a device more adaptable or easily used by diverse populations or in diverse settings.  However, increased “accessibility,” as that term is described in the draft guidance, does not appear to include cost-related considerations.

These examples of technologies and features that may lead to more effective treatment or diagnosis through their ability to address health and health care disparities may open the door for companies that may not have otherwise considered their device to be a breakthrough device.  It appears that demonstrating an advantage over standard of care with regard to a device’s ability to address a health disparity could help support a finding that the device would lead to “more effective” treatment, satisfying the first breakthrough criterion.

Finally, FDA is proposing to add language to the 2018 guidance regarding the confidentiality of breakthrough requests.  The proposed update clarifies that FDA will not disclose the existence of requests for breakthrough designation or the Agency’s decision on the breakthrough request (e.g., in response to a FOIA request), unless the designation was previously publicly disclosed or acknowledged by the sponsor.  Additionally, once a breakthrough device receives marketing authorization, FDA intends to disclose its breakthrough status for that indication for use in a list on the FDA website.  FDA recently updated this list on October 28th, announcing that there has been a total of 56 breakthrough devices that FDA has authorized for marketing (see Breakthrough Devices Program metrics here).

FDA is accepting comments on these proposed updates until December 20, 2022 via a docket established on Regulations.gov.

Categories: Medical Devices