Research with Medical Devices

Research with Medical Devices

Jane Cho, MS, MPH Associate Director of Regulatory Science

Clinical Trials Office

Challace Pahlevan-Ibrekic, MBE, CIP Director, IRB Management

Human Research Protection Office

March 21, 2019

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Agenda

? Regulatory context for clinical investigations ? When an IDE is required ? Sponsor-Investigator Responsibilities ? Application process to FDA ? IRB Submission and Requirements

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FDA Regulation

Food and Drug Administration (FDA) regulates the approval process and assures the safety, efficacy, and security of drugs, biological products, medical devices.

? Center for Drug Evaluation and Research (CDER) ? 21 CFR 312 ? Center for Biologics Evaluation and Research (CBER) ? 21 CFR 312 ? Center for Devices and Radiological Health (CDRH) ? 21 CFR 812

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FDA Regulation

Sponsor (S)

Takes responsibility for and initiates a clinical investigation

Investigator (I)

S-I Conducts a clinical investigation and

oversees the product

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Medical Device Regulations

Food, Drug and Cosmetics (FD&C) Act (1938)

? FDA authorized to oversee safety of food, drug and cosmetics

? Title 21 CFR Parts 800 ? 1299 cover regulations

Medical Device Amendments (1976)

? Established device classifications based on risk ? Established Investigation Device Exemption (IDE)

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Medical Devices

A medical device is an instrument, apparatus, implement, machine, software/application, contrivance, implant, in vitro reagent or a component part or accessory which is:

-Intended for diagnosis, cure or mitigation, treatment or prevention of a disease

-Intended to affect the structure or any function of the body -Does not achieve its primary intended purposes by chemical or

metabolic action.

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