RESEARCH TIPS
This column is devoted both to sharing new information and reminding investigators of regulatory requirements and best practices in research.
This Month’s Subject—Investigational Device Exemptions 21 CFR Part 11
Did you know?
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The FDA defines a medical device study as a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device. The term “subject” means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. This definition includes de-identified specimens.
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The FDA categorizes medical device studies as (1) exempt, Nonsignificant Risk (NSR), or Significant Risk (SR)
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Sponsors are required to provide a recommendation as to the study category and justification to the IRB where a study will be conducted.
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For Significant Risk Device studies an IDE application must be submitted to and approved by the FDA prior to beginning the study.
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For Nonsignificant Risk Device studies the IRB serves as the surrogate of the FDA, and the IDE is considered to be approved upon IRB approval.
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An approved IDE permits a device to be SHIPPED LAWFULLY for the purpose of conducting investigations of the device.
Evaluation of devices that have not been cleared for market require:
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a NSR or exemption determination by an Institutional Review Board (IRB) [(812.2(b)]. If the study involves a significant risk device, an IDE approval by the FDA (812.30)
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informed consent from all patients unless the study is a study of an In Vitro Diagnostic Device in which case certain exceptions may be made
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labeling for investigational use only
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monitoring of the study
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required records and reports.
Additional Resources
For additional information, contact the Human Research Protection Program at (413) 794-4356 or visit the following FDA websites:
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