FORM: Application for Human Research s1

FORM: Application for Human Research

Protocol Name: Principal Investigator: Primary Contact Contact Name: Info: Date:

Appendix C: Devices Please complete one form for each device whose safety or effectiveness is being evaluated in the research (Make or download additional copies of this page as needed) Name of Device: Manufacturer: Description of Device (include a brief description of the device, its purpose, how it is used and how it differs from existing devices): FDA status: 1. Is this study being done under an IDE? Yes If Yes, skip to question #8. No 2. Is this device FDA approved? Yes No 3. Is this device to be used in accordance with its PMA or 510(k) approval letter Yes (approved for use in the specified population)? No If Yes to questions #2 and #3, skip to question #9. 4. Is this a diagnostic device AND  is noninvasive* and  does not require an invasive sampling procedure that presents significant risk and  does not by design or intention introduce energy into a subject; and is not used as a diagnostic procedure without confirmation by another medically established Yes diagnostic product or procedure? No *The FDA defines the term noninvasive as the use of a diagnostic device or procedure that does not by design or intention: (1) Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or (2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os. For purposes of this part, blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for non-investigational purposes is also considered noninvasive. 5. Is this device test limited to:  consumer preference testing, or  testing of a modification, or Yes  testing of a combination of devices if the device(s) are legally marketed No device(s) AND the testing is not for the purpose of determining safety or effectiveness AND does not put subjects at risk? If Yes to either question #4 or #5, skip to question #11.  If there is an IDE exemption, or existing correspondence with the FDA, please provide documentation. If No to both of these questions, continue to question #6. Abbreviated IDE Requirements 6. Is the sponsor claiming that this device is not a significant risk device? Yes No 7. Does the protocol include a justification as to why the device is not a significant risk Yes device? No If No to either question #6 or #7, proceed to question #8. 1 Revised 8/16/10 FORM: Application for Human Research

Protocol Name: Principal Investigator: Primary Contact Contact Name: Info: Date:

If Yes to both questions, skip to question #11.

Studies that Require an IDE 8. If the device has an approved IDE please provide the IDE #: and identify the Sponsor (holder of the IDE): (choose one) MSSM Investigator: (provide specific name): Provide documentation of the IDE number (e,g. protocol imprinted with the IDE#, sponsor correspondence or FDA correspondence. If this is an investigator-held IDE, submit a copy of FDA correspondence documenting the IDE number. Manufacturing and Control: 9. If the device is Investigator-Manufactured, explain what arrangements and precautions have been taken to ensure proper manufacturing of the device and compliance with 21 CFR 812, 21 CFR 814 and Good Manufacturing Practice: Not Applicable 10. Describe the policies and procedures for storage, handling and control of distribution of the investigational device so that the device will only be administered by authorized investigators and will only be used in subjects that have agreed to take part in the research:

Coverage of Costs: 11. Will the sponsor provide the device at no cost for the research subjects (this does Yes not include the hospital covering the costs of the device)? No a. If No, please provide detailed information of who will cover the costs and how the cost level was determined:

Departmental Approval: If departmental approval is required regarding research involving devices, the PI should obtain those approvals prior to submission to the PPHS. Please attach the following items, if applicable: Device brochure that includes the following:  Description of device and its use  Reports of prior investigations with device  Proposed investigational plan  Participant selection criteria description  Monitoring procedures IDE application/ FDA’s device risk assessment or notification Documentation that the device meets criteria to be Exempt from the regulations Non-significant risk supporting documentation Determinations made by other IRBs

Signature of Principal Investigator Date

Print Name:

2 Revised 8/16/10 3 Revised 8/16/10