21 CFR 56 IRBs 21 CFR 312 Drugs 21 CFR 812 Devices IRB Continuing Education April 21 2022 So what is FDA regulated Conducting research with drugs devices supplements botanicals or biologics ID: 1007304
Download Presentation The PPT/PDF document "FDA Basics 21 CRF 50 –Protection of Hu..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
1. FDA Basics21 CRF 50 –Protection of Human Subjects21 CFR 56 - IRBs21 CFR 312 - Drugs21 CFR 812 –DevicesIRB Continuing Education, April 21, 2022
2. So, what is FDA regulated?Conducting research with drugs, devices, supplements, botanicals, or biologicsIncludes those that have received FDA approval as well as “investigational” itemsSubmitting data to the FDA to support approval/marketing
3. The FDA regulations are different…Human subject – not defined by “identifiability”…Means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.
4. The FDA regulations are different…Research = “clinical investigation”…Means any experiment that involves a test article and one or more human subjects
5. What is a device?Per Section 201(h) of the Food, Drug, and Cosmetic Act, a device is:An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:1) Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or2) Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals andwhich does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).
6. What does the IRB need to do?The FDA requires the IRB to do a “risk assessment” of devicesIf non-significant risk – no IDE is neededIf significant risk – IDE is needed
7. How does the IRB make a risk determination?Researcher must provide sufficient information:Researcher’s risk assessment and rationaleSponsor’s risk assessment and rationaleFDA determination (only when an IDE application has been submitted)FDA Significant Risk determination overrides the IRB’s decisionFDA Non-significant determination – IRB may agree or disagree
8. IRB risk determination considerationsIf a risk assessment has already been madeRisk determination for other uses of the deviceSponsor’s risk assessment and rationaleResearcher’s risk assessment and rationaleProceduresPopulationReview of the device by other IRBs
9. Non-significant risk device examplesConventional Gastroenterology and Urology Endoscopes and/or Accessories Magnetic Resonance Imaging (MRI) Devices within FDA specified parametersDaily Wear Contact Lenses and Associated Lens Care Products not intended for use directly in the eye (e.g., cleaners; disinfecting, rinsing and storage solutions)Digital Mammography
10. Significant risk device examplesSurgical Lasers for use in various medical specialtiesCardiac Bypass DevicesAuditory Brainstem Implants Dialysis Delivery Systems Injectable Collagen
11. The determination has been made…1. Documentation using the CHECKLIST – HRP-418: Non-Significant Risk Determination2. CommunicationTo the researcherTo the sponsorTo the FDA (responsibility of sponsor)
12. If FDA regulated…Additional consent form elements:FDA review of recordsClinical trial registrationRisk informationWaiver of consentNot only limited to emergency researchHarmonizes with HHSWaiver of documentation of consentMore limited than HHS
13. If FDA regulated…Items made hereIRB may require information about the manufactureConsultation with HU Risk Management or relatedControl of investigational itemsReview plan of control, tracking and handlingRecordsMaintain records about the use of the item, including records of receipt, use, or dispositionWhere obtainedIRB has authority to require use of local services
14. Questions?