IDE试验用器械的豁免.ppt

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IDE试验用器械的豁免

* * BECKER, INC. * An IRB must comply with the regulations outlined in 21 CFR §56 and §812. IRB registration is not required. To determine compliance with regulations, FDA periodically conducts reviews of an IRB’s records and procedures. Written procedures must be followed for conducting an initial review, for reporting findings and actions to an investigator, and for determining whether a study involves a significant risk device. IRB meeting minutes must document the rationale behind significant risk determinations and subsequent approval or disapproval decisions for a clinical investigation. Investigational Device Exemptions US FDA Device Clinical trial Approval * Overview Investigational Device Exemptions (IDE) Regulation 21 CFR 812 Applies to all clinical investigations of devices to determine safety and effectiveness FDA oversight of conduct of study, use of device, protection of human subjects FDA review depends upon determination of Significant Risk (SR) or Nonsignificant Risk (NSR) Device Determination made by sponsor, then IRB; FDA oversight * What is an IDE? IDE permits clinical evaluation of an investigational device (21 CFR Part 812) Investigational devices have not been cleared for marketing, are the object of an investigation Also includes legally marketed devices with specific modifications or new intended uses Clinical evaluation provides safety and effectiveness data to support approval and/or marketing clearance Clinical studies most often conducted in support of PMAs Only a small number of 510(k)s require clinical data * Purpose of IDE Regulations 812.1(a) To encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use To maintain optimum freedom for scientific investigators in their pursuit of this purpose * Significant Risk Devices Definition – 21 CFR 812.3(m) Potential for serious risk to subject’s health, safety or

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