The Food and Drug Administration (FDA) has suggested revisions to its breakthrough device program. The agency is soliciting input on two areas of the breakthrough advice it finalized in 2018 through the draft paper. The sections cover the designation review process and designation considerations. The FDA plans to extend its breakthrough program to devices that increase accessibility if it approves the proposal because they might be more useful for patients who have few or no other options because they are more accessible.
A product must have the potential to offer more effective diagnosis or treatment of a fatal or permanently disabling human disease or condition in order to be eligible for the breakthrough program. According to current FDA guidance, access to technologies is not taken into account when determining whether there is evidence that the investigational device could be more successful than current options. By stating that the agency “considers the totality of information regarding 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, the draft proposal would broaden the consideration of the “more effective” criterion.
A section titled “Reducing inequities in health and health care” is another addition the FDA is recommending for products of this nature. The regulator asserts in the proposed provision that addressing disparities is crucial for enhancing health outcomes since they exist across a variety of variables, including race and socioeconomic status. As a result, while determining whether a technology may be more effective than the standard of care, the FDA “intends to evaluate technologies and device features that potentially allow for increased accessibility.”
The FDA stated the following in their report: “For example, improved accessibility of a device may be considered as reasonably expected to be more effective if there is information supporting its use in diverse settings such that a patient population with limited or no available options may have improved adherence to a prescribed medical regimen.”
The proposal includes new language regarding confidentiality. While the agency will “generally” maintain the confidentiality of breakthrough device applications and decisions, it may discuss designations that have already been made public, such as in a statement from the sponsor, and it will make the breakthrough status of devices that are granted marketing authorizations known. The FDA is willing to receive comments and feedback on the proposed suggestions up to the middle of December.
