CLINICAL TRIALS FOR MEDICAL DEVICES

Ethics Review

(need article)

Regulatory review/Investigational Device Exemption
An investigational device exemption (IDE) (21CFR 812) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. All aspects of the IDE process are described by the FDA.

Feasibility
Review of IDEs for Feasibility Studies 

Efficacy
Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products  -- NOTE: according to the first pages, this document is outdated.  But neither of the pages it links to work.

Next Page - FDA Filing/Approval for Devices

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