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
1
Agenda
? Regulatory context for clinical investigations ? When an IDE is required ? Sponsor-Investigator Responsibilities ? Application process to FDA ? IRB Submission and Requirements
2
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
3
FDA Regulation
Sponsor (S)
Takes responsibility for and initiates a clinical investigation
Investigator (I)
S-I Conducts a clinical investigation and
oversees the product
4
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)
5
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.
6
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