General Session: FDA Clinical Research Compliance for Medical Devices: A Primer

Neil O'Flaharty, Partner, Amin Talati Wasserman LLP.

June 16, 2021

  • When does research of a medical device become subject to FDA oversight?

  • What are the key considerations for running a medical device clinical study in compliance with FDA requirements?

  • Strategies for avoiding non-compliant clinical research and running FDA-compliant studies

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The Society of Corporate Compliance and Ethics (SCCE) is a non-profit, member-based professional association. SCCE supports our members' work with education, news, and discussion forums. We are a community of leaders, defining and shaping the corporate compliance environment across a wide range of industries and geographic regions. In developing and maintaining effective ethics and compliance programs, our members strengthen and protect their companies.

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About HCCA

The Health Care Compliance Association (HCCA), is a 501(c)6 non-profit, member-based professional association. HCCA was established in 1996 and is headquartered in Minneapolis, MN. We provide training, certification, and other resources to over 10,000 members. Our members include compliance officers and staff from a wide range of organizations, including hospitals, research facilities, clinics and technology service providers.

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