US FDA Breakthrough Designation for Medical Devices and IVDs

Accelerate Innovation with FDA Breakthrough Device Designation

Bringing a novel medical device to market is a complex journey, especially when your innovation has the potential to transform patient care. The FDA’s Breakthrough Device Designation is designed to accelerate this process for technologies that address life-threatening or irreversibly debilitating conditions. This designation not only offers faster review timelines but also enables early and frequent interaction with the FDA, helping innovators align their development strategy from the outset. With growing competition in the medtech space, securing Breakthrough status can provide a critical edge: speeding up time to market, enhancing credibility, and ultimately delivering life-changing solutions to patients sooner. NAMSA provides the strategic insight and hands-on support needed to navigate this high-stakes process with confidence.

Quick Facts About the US FDA Breakthrough Device Designation Process:

• The designation enables priority review, more frequent FDA interactions, and early feedback throughout the development process.
• Breakthrough status can be granted for devices pursuing PMA, 510(k), or De Novo pathways.
• The most common therapeutic areas receiving designations include cardiovascular, neurology, and orthopedics – highlighting the urgent need for innovation in these fields.
• The number of Breakthrough Device Designations has grown dramatically – from just 11 in 2015 to 166 in 2024, peaking at 206 in 2021. This upward trend reflects the increasing demand for faster regulatory pathways for innovative medical technologies.
• Breakthrough Device Designation decisions are made by FDA within 60 days.

FDA Breaking Designation NAMSA Support

NAMSA takes a strategic and collaborative approach to FDA Breakthrough Device Designation. Our goal is to help you demonstrate eligibility, build a compelling case, and engage effectively with the FDA. Depending on your needs, NAMSA can support any stage of the Breakthrough Devices Program process, including the following:

• Determining if your device is elegible. We assess whether your device qualifies for Breakthrough Device Designation based on FDA’s four core criteria.
• Creating a compelling justification: Our regulatory experts prepare a robust dossier that clearly demonstrates your device’s eligibility – highlighting how it treats or diagnoses life-threatening or irreversibly debilitating conditions, and how it may represent a breakthrough technology, offer significant advantages over existing alternatives, or address unmet medical needs.
• Submitting all required documentation, including device description, intended use, planned marketing pathway, regulatory history, and the eligibility rationale.
• After Breakthrough Designation is granted, assisting the client with Breakthrough pre-submissions and FDA meeting plans. This may include preparing submissions, developing an agenda, practice sessions and reviewing FDA feedback (if applicable) prior to a face-to face meeting or virtual call with the Agency.
• Attending the FDA meeting with the purpose of discussing any feedback that is unclear or requires further clarification in real time to ensure your message is clearly communicated.
• In collaboration with your team, we compile the meeting minutes and submit an amendment to maintain alignment with the FDA. 

With decades of experience across a wide range of therapeutic areas – including cardiovascular, neurology, orthopedics, and more—NAMSA brings unmatched depth and versatility to every project. Our team includes former FDA professionals who understand the Agency’s expectations from the inside out, giving you a distinct advantage in regulatory communications. We have a proven track record of successful Breakthrough Device Designation submissions and a long-standing history of effective, strategic engagement with the FDA. We understand the nuances of regulatory expectations and know how to position your innovation for success. With NAMSA, you gain a strategic ally committed to accelerating your product’s path to market.