FDA Collects Input on Medical Devices Health Equity

For the purpose of guiding a possible regulatory strategy on the subject, the FDA is collecting input on health equality for medical devices.

In response to the “urgent public health need for innovative technologies that help to reduce barriers to achieving health equity,” the FDA created the discussion paper. In response to that requirement, the CDRH has pledged, as part of its strategic focus on health equality, to provide “a framework for when a device should be evaluated in diverse populations to support marketing authorisation.”

Encouraging clinical trials to produce outcomes that mirror a device’s real-world performance is one method to enhance health equity. While admitting that producing clinical data “can be complex,” the organisation stated that it has concentrated on “a few important considerations that may be relevant for FDA’s evaluation of clinical evidence” in developing its discussion paper.

The article lists elements that sponsors, and investigators may find useful in creating research objectives. The FDA advises enquiring into how the prognosis and illness burden differ among the target user community for a device in order to guide early trial design. Sponsors may also enquire as to how a certain technology could cause, aggravate, or lessen variations in results among the participants in the research.