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November 09, 2020
Breakthrough Medical Devices:
Latest Regulatory Developments
An FDAnews Webinar
Monday, Nov. 16, 2020, 1:30 p.m. – 3:30 p.m. EST
https://www.fdanews.com/breakthroughmd
Does one’s medical device provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions? If so, expedite access to the novel medical device.
Now, critically ill patients can get quicker access to these devices — and it’s all because of the FDA’s Breakthrough Device Program. Plus, there’s a proposed rule to allow for Medicare coverage the same day some of these devices receive 510(k) clearance.
This Breakthrough Medical Devices webinar on Nov. 16 will cover the details of how to use this new program to one’s advantage, including what it takes to be designated as a breakthrough device and the scope of the CMS reimbursement strategies.
Evan Phelps, Partner at Amin Talati Wasserman, LLP, will share the most significant issues that could arise when implementing the FDA guidance on breakthrough devices. He’ll discuss petition requirements, FDA criteria for selection and proposed indications for use.
During this webinar, we’ll cover:
-
The basics of the FDA’s Breakthrough Device Program - Program benefits and how the designation will push a device to market earlier
- Application requirements for a breakthrough device designation, including description of use, proposed indication for use and regulation history
- FDA criteria to identify breakthrough devices, including specific statutory criteria from Appendix I of the Breakthrough Devices Program Final Guidance
- Key elements the FDA uses to review breakthrough device applications
- Expectations around the proposed Centers for Medicare and Medicaid Services (CMS) Breakthrough Device reimbursement rule
With the FDA’s Breakthrough Device Program, gain approval and begin marketing novel medical devices faster.
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:
Breakthrough Medical Devices:
Latest Regulatory Developments
An FDAnews Webinar
Monday, Nov. 16, 2020, 1:30 p.m. – 3:30 p.m. EST
https://www.fdanews.com/breakthroughmd
Tuition:
$287 per site
Easy Ways to Register:
Online: https://www.fdanews.com/breakthroughmd
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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