What Is FDA Breakthrough Designation?

The FDA’s Breakthrough Devices Program is intended to help speed new medical devices to market through expedited assessment and review processes. By providing manufacturers with access to FDA experts using special mechanisms only available to breakthrough devices, this program offers the opportunity to address questions or concerns about the product under development during the premarket review phase. FDA Breakthrough Device designation helps prevent delays that can come up during FDA review for devices that treat or diagnose life threatening or irreversibly debilitating diseases or conditions. The intent of the breakthrough program is to provide patient’s access to these important devices through a more-streamlined review process.

How Breakthrough Device Designation Helps Manufacturers

The program benefits manufacturers by giving them increased support from FDA review staff such as more frequent opportunities for direct communication with the FDA. Other advantages it provides include FDA’s receptiveness to a better balance between premarket and postmarket data collection and more adaptable clinical study designs.  All of this adds up to making the entire process easier for companies that produce novel medical devices with the potential for high public health impact.  Prior to the breakthrough program, interactions with FDA for novel devices could be a long and difficult process.  The breakthrough device program is intended to address these challenges for important devices that treat or diagnose life threatening and irreversibly debilitating diseases and conditions; i.e., for those Americans most in need of new and effective products.

Challenges of Obtaining Breakthrough Designation

Obtaining a breakthrough designation is difficult.  A device must meet certain statutory criteria before it can be considered eligible for the program. For instance, the manufacturer must demonstrate the device has a reasonable expectation of being a more effective therapy or diagnostic when compared to existing alternatives for the target patient population.  Convincing FDA that a device early in development could be better than anything on the market today is a difficult task. This is why it is important for manufacturers to clearly and succinctly describe their product, its potential, and its advantages over alternatives when making a request for breakthrough designation to the FDA. Generally, the request should include a description of the device, an indication of its proposed use, its regulatory history, and how it meets the statutory criteria for being designated as a Breakthrough Device. 

Why Choosing MCRA as a Partner Can Ensure Success

Guiding a new product through the process calls for the assistance of Breakthrough Device designation consultants who understand it better than anyone. Fortunately, MCRA offers the right combination of experience and technical know-how to help clients navigate this program and obtain the designation for their breakthrough medical devices.

Our cross-disciplinary approach, deep bench of talent across multiple therapeutic specialties, and carefully cultivated relationships and experience with U.S. government agencies enables us to help clients operate, expand, and achieve their long-term business objectives. MCRA understands how a breakthrough designation can fit into the device lifecycle and facilitate passage through the complete developmental process, including development and execution of clinical testing, regulatory application through clearance/approval, and commercialization. MCRA strives to provide clients with the best representation to regulatory agencies in demonstrating the science, safety, and efficacy of their technologies. 

MCRA’s Breakthrough Device designation consultants have been successful in obtaining the breakthrough device designation for over 100 devices.  When combined with MCRA’s long history and deep expertise in navigating the review process for hundreds of US FDA submissions ranging from 510(k)s to PMAs for first-in-class medical devices, MCRA’s Breakthrough Device designation consultants speed development and assessment of breakthrough devices that promise a more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions.


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Breakthrough Devices Experience

MCRA is a world-class provider of regulatory strategy and reimbursement advice for medical devices; we are committed to aiding our clients to provide patients with timely access to medical devices by speeding up their development, assessment, and review. MCRA has a successful track record in obtaining Breakthrough Device Designation for over 100 different products across a range of clinical specialties.

The Breakthrough Device process involves two main steps:

  1. A Designation Request for Breakthrough Device (Q-sub) to the US FDA, and if granted
  2. Unique processes to expedite development of the breakthrough device and prioritize premarket reviews of the device.

MCRA’s experience with breakthrough devices includes multiple therapeutic areas, including:

  • Orthopedics & Orthopedic Devices

  • Cardiology & Cardiovascular Devices

  • Spinal Devices

  • Wound Care & Dermatology Devices

  • Biologics & Combination Devices

  • Neurology & Neurosurgical Devices

  • Imaging & Robotic Devices

  • Digital Health

  • General & Plastic Surgery Devices

U.S. Regulatory Services

MCRA has industry-leading specialization in the full spectrum of medical devices, with strong regulatory and scientific leadership.

The MCRA team can support you in seeking a breakthrough device designation. Related services include:

  • “Designation Request for Breakthrough Device” Q-Submission

  • Support during interactive communications between FDA and you

  • Support during expedited manufacturing inspection

  • Other Q-Submissions and Pre-submissions unique to the program such as Sprints and Data Development Plans

  • Global and U.S. regulatory strategy

  • Regulatory landscape assessment

  • Gap analysis

  • De Novo

  • 510(k)

  • Premarket Approval (PMA)

U.S. Reimbursement Services

With more than 75 years of combined U.S. reimbursement, market access, and health economic experience, MCRA’s Reimbursement, Health Economics, and Market Access team guides companies through the complex and evolving reimbursement pathways across a product’s lifecycle.

MCRA’s reimbursement services are unique and effective in assisting companies in achieving successful market adoption. MCRA’s integrated services in regulatory, clinical, and reimbursement inform an effective and integrated strategy that sets our clients’ products up for commercial success.

Obtaining Breakthrough Device Designation from the FDA classifies your device as genuinely novel and provides some benefits for products that seek separate payment under Medicare’s hospital payment systems.

Due to the recent policy changes by the Centers for Medicare and Medicaid Services (CMS), breakthrough products now have an alternate way to qualify for device transitional pass-through payment status under the Medicare Hospital Outpatient Prospective Payment System (OPPS). For applications received on or after Jan. 1, 2020, CMS is no longer evaluating BDD products in terms of the current substantial clinical improvement criteria, and all breakthrough devices now qualify for the quarterly approval process for device pass-through payment.

In addition, under the 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule, CMS finalized an alternative new-technology add-on payment (NTAP) eligibility pathway for transformative new devices under Medicare. BDD products that receive FDA marketing authorization are considered new and not substantially similar to existing technology. CMS acknowledges that breakthrough devices will not have an adequate amount of time to demonstrate clinical improvement, so BDD products also do not have to meet the newness or substantial improvement criteria under the NTAP program (but they must meet cost criteria).

MCRA can assist in your plan to establish reimbursement and separate payment with CMS for your device with breakthrough status.

Related reimbursement services:

  • Reimbursement and market access landscape assessments

  • Strategic reimbursement plan development and execution

  • Payer engagement and coverage policy assistance

  • Patient access program reimbursement support services

  • Advisory board panel with MCRA’s Life Sciences Expert Advisory Panel (LSEAP)

  • Healthcare policy development and advocacy

  • Coding applications – CPT, ICD-10, HCPCS

  • Predictive economic utilization modeling


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