WCG FDAnews

Medical Device Regulatory Policy:

Breakthrough Technologies, STeP and — Wait for It — Reimbursement

An FDAnews Webinar

Tuesday, Sept. 21, 2021, 1:30 p.m.-3:00 p.m. EDT

https://wcg.swoogo.com/medical-device-regulatory-policy

Be an innovator and not a follower. Get medical devices to market faster.

The FDA’s Breakthrough Devices Program and Safer Technologies Program (STeP) for Medical Devices can be instrumental… if one knows the ins and outs of eligibility, submission timing and content requirements. Not to mention the reimbursement implications.

Kristin Davenport and Rujul Desai, both of counsel at Covington & Burling LLP, will share what one must know and do to get 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 the pathway for Medicare coverage and the Medicare Coverage of Innovative Technology (MCIT) program, explaining:


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 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 devices. This webinar is the best move.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally

to learn about our special multisite discount.

Webinar Details:

Medical Device Regulatory Policy:

Breakthrough Technologies, STeP and — Wait for It — Reimbursement

An FDAnews Webinar

Tuesday, Sept. 21, 2021, 1:30 p.m.-3:00 p.m. EDT

https://wcg.swoogo.com/medical-device-regulatory-policy

Tuition:

$297 per site

Easy Ways to Register:

Online: https://wcg.swoogo.com/medical-device-regulatory-policy

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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Topics #breakthrough #Reimbursement #September #step #Technologies #wait #Webinar