VCOM Institutional Policy and Procedure Manual

5. DEFINITIONS Medical Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:  Recognized in the official National Formulary, or the U.S. 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  Intended to affect the structure or any function of the body which does not achieve any of its’ primary intended purposes through chemical action within or on the body, and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes [FD&C 201(h)]. Significant risk device: A device intended as an implant which presents a potential for serious risk to the health, safety, or welfare of a subject [21 CFR 812.3m(1)]. Non-significant device: Any device that does not meet the definition of significant risk device Investigational Device Exemption (IDE) required investigational devices: Device studies that collect safety and effectiveness data whether or not the results are intended for FDA review 6. PROCEDURE 1. The IRB Chairperson will determine if the protocol involves a device, as defined by the FD&C Act, and the type of review required for either initial and/or continuing review. a. If the type of review indicated is full board, as determined by the level of potential risk to subjects, the IRB coordinator will place the protocol on the next agenda for review. b. If the type of review indicated is expedited, the Chairperson will designate two IRB members to conduct the review. 2. The IRB will make the risk determination of significant/non-significant based on: a. the definitions as denoted in this SOP b. the sponsor explanation as to why the device is not a significant risk device. c. The FDA decision letter as obtained from the sponsor 3. If the device is designated as significant risk: a. The IRB must obtain the IDE application to FDA as submitted by the sponsor, and b. The IDE regulations, as denoted in 21 CFR 812, must be adhered to by the sponsor/principal investigator. c. The study may not commence without FDA and IRB approval 4. If the device is designated as non-significant risk: a. There will be no formal IDE application to FDA. b. Abbreviated IDE regulations, 21 CFR 812.2(b) must be adhered to by the sponsor/principal investigator c. It will include studies exempt from 812 5. If the IRB determines the device is non-significant risk and approves the study, this approval will serve as an approved application for IDE 6. The IRB will determine if the study requires an IDE based on the following criteria: a. Studies that support research or marketing applications b. Studies of investigational devices c. Studies of new indications of already approved devices