Best practices for obtaining breakthrough designation using the US FDA’s Breakthrough Devices Program
£50.00
Discover how to strategically secure breakthrough device designation through proven approaches and practical insights from FDA experience
English
The US Food and Drug Administration’s (FDA’s) Breakthrough Devices Program is intended to expedite the development and review of medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. This article by John Doucet provides a comprehensive overview of the Program’s structure, designation criteria, and special regulatory interaction mechanisms available to device manufacturers. It outlines best practices for obtaining a breakthrough designation, emphasising the importance of early submission, clear definition of indications for use, and alignment on standard of care. Common pitfalls in designation requests are also identified, including overly broad or vague indications and insufficient evidence. Finally, the article highlights the benefits of the Program, including streamlined communications, regulatory flexibility, and increased engagement opportunities.
Specification: 14 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the November 2025 issue of the Journal of Medical Device Regulation.
