Hot FDA Compliance Issues for 2022

Neil OFlaherty, Partner, Amin Talati Wasserman LLP.

2022-06-08

  • Learn what FDA is focused on this year in assessing and assuring compliance of medical device clinical investigations.

  • What types of device clinical investigation violations are triggering compliance letters and enforcement actions?

  • What should you do to meet FDA expectations and avoid regulatory problems in this area?

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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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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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