Working with the FDA: Medical Devices and Regulatory Touchpoints

This webinar discusses practical and strategic approaches to interacting with FDA during medical device development.

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About this Webinar

Medical device manufacturers and clinical investigators are responsible for conducting investigations to demonstrate safety and effectiveness of Class III devices and those on the Class II/III cusp. To be successful, sponsors and investigators need to skillfully approach the FDA as a collaborative partner. There are several opportunities to work with the FDA, from pre-submission correspondence through marketing application.

This webinar examines the regulatory touchpoints with the FDA during medical device development, with an eye toward uncovering those practical strategies that a device sponsor or investigator can take to streamline the path to market clearance or approval.

Webinar Demo:

Release Date: June 9, 2022

Language Availability: English

Suggested Audiences: Compliance Professionals, Faculty and Post-Docs, General Counsel, Principal Investigators, Research Administrators, Sponsors

Organizational Subscription Price: Included as part of an annual subscription to our All Access Webinar Package
Independent Learner Price: $49 per person

Webinar Content

Working with the FDA: Medical Devices and Regulatory Touchpoints

Presented by: Robert Michalik, JD, RAC - RegulatoryPro Consulting

Learning Objectives:

  • Examine the legal and regulatory requirements for executing a successful clinical investigation of a medical device.
  • Explore the practical aspects of clinical development and FDA compliance for medical devices, including FDA touchpoints.
  • Discuss Breakthrough Device designation criteria as a regulatory strategy.

Recommended Use: Required
ID (Language): 20673 (English)

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