Medical Device Regulatory Policy: Breakthrough Technologies, STeP and Wait for It Reimbursement

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Are you an innovator… or a follower? Getting your device into the FDA’s Breakthrough Devices Program or Safer Technologies Program (STeP) for Medical Devices could mean the difference.

For inclusion, you must know the relevant eligibility criteria for participating and the benefits of each, as well as an understanding of submission timing and content requirements. What if you have two devices with the same intended use? Or a combination product?

Not to mention the reimbursement implications: the pathway for Medicare coverage of breakthrough devices is not completely clear and the delay of the Medicare Coverage of Innovative Technology (MCIT) program has strategic reimbursement considerations.

This webinar will share what you must know and do to get your devices included. Using their expertise from the Medical Devices and Diagnostics area of the firm’s Food, Drug and Device practice, they’ll also discuss associated reimbursement strategies and how MCIT fits into larger market access issues.

Webinar Takeaways:

  • STeP and breakthrough criteria, including the submission timing and content requirements for obtaining a breakthrough designation or inclusion into STeP
  • Benefits of breakthrough designation and inclusion into STeP, including expediting approval time
  • Pathway for nationwide coverage of breakthrough devices, and its impact on your device development program
  • Strategic reimbursement considerations, including how to optimize payment


Obtaining a breakthrough designation or STeP inclusion — not to mention reimbursement — can be a game changer for your devices. This webinar is your best move.

Who Will Benefit:

  • Regulatory personnel
  • Quality professionals
  • Compliance specialists
  • Quality assurance and quality control leaders
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