FDA BREAKTHROUGH DEVICE CONSULTING

Trusted guidance for breakthrough
devices

With experience supporting 100+ Breakthrough Device designations, we help companies maximize the advantages of the FDA's Breakthrough Devices Program from strategy through submission.

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Streamline your path to market with our expert Breakthrough Device Designation consultants

The FDA Breakthrough Devices Program offers a powerful regulatory mechanism for medical devices and device-led combination products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. However, program approval requires a highly rigorous, data-backed justification.

As your trusted FDA regulatory advisor, IQVIA MedTech helps assess eligibility, develop compelling Breakthrough Device Designation requests, and prepare engagement strategies for FDA interaction throughout development. With experience supporting 100+ Breakthrough Device designations, Our team evaluates early clinical evidence, articulates your technology's differentiators, and guides FDA interactions to support a strong designation strategy.

The benefits of Breakthrough Designation

Securing FDA Breakthrough status provides you with several significant strategic and operational advantages:

Expedited Interactive Review Sprints: Accelerate FDA feedback on technical topics, potentially reducing review timelines by up to 60%.
Prioritized Communication: Enable earlier and more frequent engagement with the FDA, including faster feedback on regulatory strategy, study designs, and testing plans.
Enhanced Data Flexibility: Support innovative evidence-generation approaches, including real-world evidence, adaptive trial designs, smaller clinical studies, and post-market data collection.
Increased Investor Confidence: Strengthen opportunities for funding, strategic partnerships, and commercial growth.

Targeted services for the FDA Breakthrough Devices Program

Combining regulatory and therapeutic expertise with longstanding experience engaging with the FDA, our team helps companies navigate submission requirements and key regulatory milestones.

Eligibility & Gap Analysis: Evaluate your clinical technology against strict FDA criteria to determine whether it qualifies for the Breakthrough Devices Program.
Pre-Submission and Strategy: Prepare and execute strategic pre-submission packages to align with the FDA on clinical endpoints prior to the formal designation request.
Designation Request Development: Compile robust scientific, clinical, and analytical evidence to build a bulletproof case for breakthrough device designation.
Sprint Discussions & Interactive Review Support: Facilitate rapid, collaborative interactions with FDA review teams to resolve critical protocol or data questions efficiently.
Clinical Data Architecture: Design clinical trial protocols optimized to gather the specific endpoints necessary to satisfy both expedited FDA approval and insurance reimbursement requirements.
Post-Market Compliance Planning: Transition seamlessly from accelerated approval pathways into robust post-market quality systems and surveillance.

MCRA is now part of IQVIA MedTech

Your Strategic Partner in Regulatory Success

IQVIA MedTech and MCRA bring together regulatory expertise with advanced analytics, technology, and global reach. Whether you're preparing for FDA submission, EU MDR certification, or global market entry, our integrated team provides the strategic guidance and operational support to move your product forward.

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MCRA’s extensive regulatory knowledge of cancer IVDs [was] instrumental in the development of our breakthrough device submission for our bladder and upper tract urothelial cancer test, Bladder CARE™. With [their] assistance, our team was able to respond to the FDA’s request for additional information in an efficient manner.

Yap Ching Chew
Chief Operating Officer, Pangea Laboratory

Helping Darmiyan successfully navigate
Breakthrough
Device
Designation

THERAPY
Neurology, Digital Health

SERVICES
Digital Health, AI & Imaging Center, US Regulatory

Darmiyan, Inc., is a San Francisco-based pioneering brain technology (deep-tech) company focused on developing innovative and rapidly scalable products for brain health screening and monitoring. Darmiyan retained MCRA for its broad and deep experience in Neurology, Digital Health, and Artificial Intelligence (AI).

Darmiyan was seeking a Breakthrough Device Designation for BrainSee, a novel medical AI algorithm that processes a patient’s MRI and cognitive scores to help doctors determine the patient’s likelihood of progression from mild cognitive impairment to Alzheimer’s dementia.

Darmiyan needed MCRA’s help developing the evidence and strategy for submission of a De Novo request, as well as assistance with data collection and data management.

MCRA’s Neurology and Digital Health regulatory expert teams collaborated closely with the client to obtain Breakthrough Device Designation (2021) and navigate the rigorous FDA review process to secure granting of the De Novo request from the FDA (January 2024).

WHAT THE CLIENT IS SAYING

“Darmiyan feels extremely fortunate to have partnered with MCRA to support our successful FDA submissions. The FDA Breakthrough Device Designation for BrainSee was a critical foundation for FDA collaborations during development, review, and granting of the De Novo request.”

— Kaveh Vejdani, Co-founder, Chief Medical & Technology Officer at Darmiyan

Today, BrainSee is helping patients take charge of their health with early access to Alzheimer’s evaluation, diagnosis, and treatment.

98%
of patients report comfort and ease during scans

92%
of users see improved quality of life from personalized recommendations

95%
of patients feel more informed about their brain health

WHAT THE CLIENT IS SAYING

“MCRA is truly unique to have world-class scientific and regulatory expertise in Neurology, Digital Health, and AI that are needed to guide novel and ground-breaking devices like BrainSee through the FDA review process. MCRA’s level of support spanned the entire spectrum and included leading our interactions with FDA, collaborating on development of test protocols, and assistance with writing the submissions.”

— Kaveh Vejdani, Co-founder, Chief Medical & Technology Officer at Darmiyan

Therapeutic and device specialization powering MedTech regulatory consulting

The IQVIA MedTech team features former regulatory agency officials, biostatisticians, clinicians, medical writers, and biomedical engineers with specialization in an array of MedTech therapeutic areas:

Cardiovascular
Neurology
General & Plastic Surgery
Orthopedics, Spine & Musculoskeletal
Metabolic, Endocrine & Gastrointestinal
In Vitro Diagnostics
Digital Health
And more

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The journey to Breakthrough Device Designation is long and challenging. Pick the right partner.

Don't navigate complex FDA pathways alone. Work with our specialized consultants to de-risk your strategy and unlock priority FDA status.

Frequently asked questions about Breakthrough Device Designation

Devices granted entry into the Breakthrough Devices Program benefit from priority review, which places their files at the front of the FDA review queue. It also unlocks interactive review features — such as sprint discussions and regular, informal check-ins with FDA review staff — and provides a dedicated pathway for senior management engagement to resolve complex scientific disputes quickly.

While you do not need final clinical trial data to apply, you must provide a sound scientific rationale and preliminary clinical, non-clinical, or bench data demonstrating a reasonable expectation that the technology will provide more effective treatment or diagnosis than current U.S. standards of care. Our consultants excel at synthesizing early-stage data to build this justification.

No. A Breakthrough Device Designation does not alter the FDA's strict scientific and regulatory standards for safety and effectiveness. However, it significantly expedites and streamlines the premarket review process [510(k), De Novo, or PMA] by allowing manufacturers to address regulatory questions interactively throughout development rather than waiting until the final submission.

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Learn about our other US FDA Regulatory Consulting & Submission Support services.