Program assists needed products with access to US market
The U.S. Food and Drug Administration (FDA) has established the Breakthrough Devices Program, a voluntary program that aims to expedite the development, assessment, and review of medical devices that demonstrate potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.
About the program
The Breakthrough Devices Program is designed to help medical device manufacturers bring innovative devices to market more quickly, while also ensuring that these devices are safe and effective for patients. The program provides manufacturers with a variety of benefits, including early and frequent communication with the FDA, priority review for certain applications, and flexibility in the type and quantity of clinical data required for approval.
Key feature of the program
One of the key features of the Breakthrough Devices Program is the early and frequent communication with the FDA. Under this program, manufacturers are provided with a dedicated point of contact within the agency, who can provide guidance and feedback throughout the development and review process. This communication can help to ensure that manufacturers are addressing the FDA’s concerns early on in the process, which can help to avoid delays and reduce the likelihood of application rejections.
Priority review for breakthrough devices
Another important feature of the Breakthrough Devices Program is the priority review for certain applications. Under this process, eligible applications are given priority review status, which can help to expedite the review process and reduce the time to market. In addition, manufacturers may be able to leverage existing clinical data to support their application, which can help to reduce the cost and time associated with conducting new clinical studies.
Eligibility
To be eligible for the Breakthrough Devices Program, medical device manufacturers must meet certain criteria, including the ability to demonstrate that their device meets an unmet medical need, has the potential to provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease, and provides a significant improvement to existing technologies.
Initial success
The Breakthrough Devices Program has already proven to be successful in helping medical device manufacturers bring innovative devices to market more quickly. For example, the FDA recently approved a breakthrough device for the treatment of chronic obstructive pulmonary disease (COPD) under this program, which is the first non-drug treatment for COPD to receive approval in more than a decade.
Overall, the Breakthrough Devices Program represents an important step forward in the FDA’s efforts to expedite the development and review of innovative medical devices. By providing manufacturers with early and frequent communication with the FDA, priority review for certain applications, and flexibility in the type and quantity of clinical data required for approval, the Breakthrough Devices Program can help to bring more effective and life-saving devices to market more quickly, while also ensuring patient safety.
Related links
Read more about the Breakthrough Devices Program here.
See a list of breakthrough devices here.
Would you like to see if your product may qualify for the Breakthrough Devices Program? Contact us.