Breakthrough Devices Program

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 the device lifecycle and can assist you 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. One critical step to expedite time to market is the Breakthrough Devices Program. This program replaces the old Expedited Access Pathway and Priority Review for medical devices from the US FDA. MCRA’s team of experts has successfully navigated hundreds of US FDA submissions ranging from 510(k)s to PMAs involving advanced first-in-class medical devices. MCRA has been successful in obtaining breakthrough devices designation to speed development and assessment of devices that promise a more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions.


Contact a Breakthrough Devices Designation Regulatory Expert


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 several products.

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. Processes to expedite device development and prioritize premarket reviews.

MCRA’s experience 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
  • 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


Contact a Breakthrough Devices Designation Regulatory Expert