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It is the policy of the Organization that research involving medical devices must be reviewed and approved by an IRB before the research may begin. The IRBs will determine at a convened meeting whether the research represents non-significant risk device research or significant risk device research. The IRB will document the NSR determination in the minutes. Proposals that are determined to represent significant risk device research may not proceed without submission of an Investigational Device Exemption (IDE) application to the FDA and subsequent receipt of confirmation of the FDA decision on the application.
Researchers who serve as a sponsor/investigator for an IDE research project are required by the Organization to follow FDA regulations 21 CFR 812 Subpart C applicable to sponsor responsibilities. Device accountability is the direct responsibility of the IDE sponsor/investigator. Compliance Monitoring Specialists of the OHSR will perform a site visit of an investigator holding an IDE to assess compliance with FDA sponsor requirements in 21 CFR 812 before initiation of the research, and recommend corrective actions where appropriate. The monitors will conduct a follow-up routine monitoring visit one year after the pre-enrollment visit. Subsequent monitoring visits may be performed, if necessary.