Draft Guidance for Device Industry and FDA - Postmarket Surveillance

(complianceonline.com)

This webinar will cover FDA's Draft Guidance on Post market Surveillance Studies for device manufacturers Under Section 522. It will help you understand the proposed changes and agency expectations regarding different stages of Post market Surveillance Studies.

Why Should You Attend:

Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the Food and Drug Administration (FDA) can obtain additional safety and/or effectiveness data for a device after it has been cleared through the 510(K), PMA, HDE or PDP process.

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