Medical Device Premarket Review Pathways and FDA Mechanisms for Expedited Review – Webinar Recording/Transcript
Finding a successful premarket pathway for your medical device can bring effective, crucial treatments to patients at a quicker speed, saving lives and improving symptoms. There are multiple ways to gain a faster review — or reach a customer base within an expedited time frame — but none of them are without complexity.
Do you have a device that you’re considering pushing forward to the market at a faster than typical speed? Have you been trying to better understand the Breakthrough Designation process or the recent Safer Technologies Program for Medical Devices (STeP)? Is your team interested in learning more about 510(k), de novo or PMA pathways?
The Medical Device Premarket Review Pathways and FDA Mechanisms for Expedited Review presentation details the avenues that you can take to achieve a successful premarket review from the FDA. Legal and regulatory expert Michael Gaba will share insights into the final guidance from the FDA around the STeP program and how navigating the eligibility criteria and submission requirements differ from those necessary to obtain a Breakthrough Designation. He’ll also discuss specific questions around situations that could arise for an organization jumping into this process, like what to do with two devices that have the same intended use. Finally, he’ll share his thoughts on the current state of the Medical Coverage of Innovative Technology (MCIT) Pathway.
Key Webinar Takeaways:
- FDA Premarket Review Pathways
- Best practices for interacting with the FDA
- Criteria and processes for various pathways
- Submission timing and content requirements for obtaining a designation
- Eligibility for designation for specific situations, including two devices with the same intended use or combination considerations
- Breakthrough Device Designation and STeP
- Criteria for Breakthrough Device Designation
- Submission timing and content requirements
- Benefits of breakthrough designation or STeP program inclusion
- Medical Coverage of Innovative Technology (MCIT) Pathway
- Updates on the current MCIT program status
- CMS’ final rule on coverage, repeal of that rule and concerns around the original provisions and plans
- MCIT connections to the upcoming 21st Century Cures Act
Order today for insights into which process is best for you and how you can find success at the end of the journey.
Meet Your Presenter
Michael M. Gaba, vice chair of Polsinelli’s FDA practice, draws on more than 25 years of experience to provide strategic FDA regulatory, Medicare policy and federal relations counsel to an array of companies developing a variety of life sciences products. This includes assisting clients in navigating the FDA’s premarket regulatory pathways and in postmarket compliance matters on products that include traditional medical devices, digital health-based products, biotechnologies, biologic-device combinations and pharmaceuticals. He also works with members of Congress and executive branch officials to develop, enact and implement policy changes.
Who Will Benefit
- Medical device companies
- Digital health companies
- Regulatory affairs specialists
- Compliance specialists
- Quality specialists
- QSR staff
- Inspections and audit team members
- Postmarket safety professionals
- Submissions and approvals staff
- Research and development team members
- Commercial operations staff
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Aug. 9, 2022