Product Details
In the past, it’s been difficult to get marketing authorization from the FDA for novel medical device technologies — and even if those authorizations were made, it could take years for a Centers for Medicare and Medicaid Services (CMS) coverage decision. Not anymore.
With the Breakthrough Device Program, critically ill patients can get quicker access to these devices. Additionally, CMS has published 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 your advantage, including what it takes to be designated as a breakthrough device and the scope of the CMS reimbursement strategies. Through our expert advice, you’ll discover how to navigate this helpful and profitable policy.
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 CMS Breakthrough Device reimbursement rule
With the FDA’s Breakthrough Device Program, you and your team can gain approval and begin marketing your novel medical device faster. Join us by registering now.
Meet Your Instructor
Evan Phelps, partner at Amin Talati Wasserman, LLP, specializes in medical device law and has been advising and representing companies before the FDA for nearly 20 years. His experience spans the breadth of the FDA’s medical device regulatory requirements. He has helped clients obtain marketing authorizations, comply with ongoing regulatory controls and avoid or address the aftermath of an FDA enforcement action.
Who Will Benefit
- Medical device manufacturers
- Medical technology development firms
- Medical technology start-up companies
- Teams developing marketing plans for medical devices
- Manufacturers of novel medical technologies that do not fit neatly into the FDA’s established device approval process
- Teams searching for reimbursement strategies
- Quality professionals
- Regulatory affairs professionals
- QSR professionals
- Post-market safety teams
- Submissions and approvals teams
- Research and development staff
- Commercial operations staff