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FDAnews Device Daily Bulletin
Aug. 9, 2012 | Vol. 9 No. 156
Canada Offers Guidance on Evidence for Class III, IV Device Applications
Makers of Class IV devices that choose not to use a summary technical documentation (STED)-based license or amendment application must provide details on manufacturing and quality controls, a device-specific quality plan and process validation studies, according to a Health Canada final guidance. Applicants should also include a risk assessment and risk-reduction measures that satisfy the agency’s safety and efficacy requirements.
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