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.
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: $300 per year/per site or included as part of an annual subscription to our All Access Webinar Package
Independent Learner Price: $49 per person