The FDA recently finalized a guidance document on the Breakthrough Devices Program. The program is for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program may also be applicable to certain devices that benefit populations impacted by health and/or health care disparities, thereby promoting and advancing health equity. The Breakthrough Devices Program is intended to help patients have more timely access to designated medical devices by expediting their development, assessment, and review. Benefits of the program include:
- Interactive and timely communication throughout the review process of regulatory submissions;
- Pre/Postmarket balance of data collection;
- Efficient and flexible clinical study design;
- FDA review team support;
- FDA Senior management engagement;
- Priority review of marketing submissions;
- Expedited FDA review of manufacturing and quality systems compliance for PMAs.
Clinical data are not required for submission of a Breakthrough Device Designation Request; bench and/or animal data may be sufficient. When assessing eligibility for the Breakthrough Devices Program, FDA 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. For example, as part of FDA’s Breakthrough Devices Program eligibility assessment, FDA will consider:
- If a device is designed to address a pathophysiological or clinical characteristic associated with certain populations, such as those arising from social factors, phenotypic variations, pathophysiology, and/or response to treatment, that could have a clinically meaningful impact for the treatment or diagnosis of the condition in those populations;
- If a device is tailored to address unmet needs in populations with rare conditions with limited diagnostic and treatment options; and
- If a device has the potential to offer a clinically meaningful impact through improved accessibility, for example, by including user features that are adaptable or more easily used by diverse populations or allow for use in more diverse settings.
More information on the Breakthrough Devices Program is available here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program
The Office of Regulatory Affairs and Quality is available for consultation and support of Breakthrough Device Designation Requests. Please fill out the service request form for assistance: https://medschool.duke.edu/research/research-support/research-support-offices/office-regulatory-affairs-and-quality/regulatory