Module 15 Presentations

15/04/2024

Valid Scientific Evidence Defined 21 CFR 860

Typically more flexible than EU

• 21 CFR 860.7(c)(2) provides examples of scientific evidence • Well-controlled investigations • Partially controlled studies • Studies and objective trials without matched controls • Well-documented case histories conducted by qualified experts • Reports of significant human experience with a marketed device • Reasonable assurance of safety and effectiveness of a device under its conditions of use (intended use) • May vary according to characteristics of the device, its conditions of use, the existence and adequacy of warnings and other restrictions 21 CFR 860 is an overlooked part of US Regulations

The Organisation for Professionals in Regulatory Affairs

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My device is novel, can I expedite the process?

The Organisation for Professionals in Regulatory Affairs

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