Law Flash
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- Negotiated one of the largest criminal settlements of the last decade affecting the medical device industry.
- Assisted both Congress and CDRH in defining certain FDAMA mandates.
- Redefined and restructured agency jurisdiction of, and regulatory pathway for, certain biologic-related medical devices.
- Removed threatened GMP consent decree for a large diagnostic instrumentation manufacturer.
- Helped secure important new premarket approval based solely on foreign published data.