Step 2: Determining the FDA Regulatory Requirements for use of your Drug or Medical Device (IND or IDE Exemption)
After determining that you are using a drug or medical device, you need to know the regulatory requirements that apply to your clinical trial. Drug regulations can be found in [21 CFR 312] and device regulations can be found in [21 CFR 812]. For further guidance, please contact OCR Regulatory via email at psom-ind-ide@pobox.upenn.edu. Some reviews of drugs and devices may be deferred to the FDA or may have a requirement for FDA review (i.e. certain grants); see Step 5 for additional details.
Drugs and the IND Regulations
Drug studies may fall into two categories:
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Medical Devices and the IDE RegulationsMedical device studies may fall into several different categories:
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