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

Live Webinar: Medical Device Regulatory Policy: Breakthrough Technologies, STeP and Wait for It Reimbursement When: Thursday September 9, 2021 - 01:00 PM Duration: 90 Minutes.

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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. 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