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Medical Device Premarket Review Pathways Webinar on August 9, 2022

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FALLS CHURCH, Va. (PRWEB)

Medical Device Premarket Review Pathways and

FDA Mechanisms for Expedited Review

An FDAnews Webinar

Tuesday, August 9, 2022, 1:30 p.m. – 3:00 p.m. EDT

https://wcg.swoogo.com/md-premarket-review-pathways

Finding a successful premarket pathway for a 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.

The Medical Device Premarket Review Pathways and FDA Mechanisms for Expedited Review webinar will detail the avenues that devicemakers 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 include:


  • FDA Premarket Review Pathways


a. Best practices for interacting with the FDA

b. Criteria and processes for various pathways

c. Submission timing and content requirements for obtaining a designation

d. Eligibility for designation for specific situations, including two devices with the same intended use or combination considerations

  • Breakthrough Device Designation and STeP


a. Criteria for Breakthrough Device Designation

b. Submission timing and content requirements

c. Benefits of breakthrough designation or STeP program inclusion

  • Medical Coverage of Innovative Technology (MCIT) Pathway


a. Updates on the current MCIT program status

b. CMS’ final rule on coverage, repeal of that rule and concerns around the original provisions and plans

c. MCIT connections to the upcoming 21st Century Cures Act

Attend this webinar for insights into which process is best and how to can find success at the end of the journey.

Webinar Details

Medical Device Premarket Review Pathways and

FDA Mechanisms for Expedited Review

An FDAnews Webinar

Tuesday, August 9, 2022, 1:30 p.m. – 3:00 p.m. EDT

https://wcg.swoogo.com/md-premarket-review-pathways

Tuition:

$287

Easy Ways to Order:

Online: https://wcg.swoogo.com/md-premarket-review-pathways

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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