VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004A8

Edward Via College of Osteopathic Medicine

Policy Order No.: R004A8 Effective Date: April 12, 2024

__________________________ Dixie Tooke-Rawlins, D.O. President ___________________________________________________________________________________ VCOM Policy on Humanitarian Use Devices ___________________________________________________________________________________ 1. PURPOSE ..........................................................................................................................................1 2. POLICY STATEMENT ...................................................................................................................1 2.1. Definitions .......................................................................................................................................1 2.2. HUDs In Clinical Care ....................................................................................................................2 2.3. HUDs Used in a Clinical Investigation ...........................................................................................3 2.4. Emergency Use of a HUD ...............................................................................................................4 3. CONSIDERATIONS FOR PROMPT REPORTING ...................................................................4 4. REFERENCES ..................................................................................................................................4 5. DURATION OF POLICY ................................................................................................................5 Signature on File 1. PURPOSE This policy describes the policies and procedures about medical devices that have been classified by the Food and Drug Administration (FDA) as humanitarian use devices (HUDs). The VCOM IRB requirements for HUDs differ depending on whether the use is for clinical or research purposes and whether the clinical use is an emergency or non-emergency situation. 2. POLICY STATEMENT It is the policy of the Edward Via College of Osteopathic Medical School Institutional Review Board (VCOM IRB) to review and approve the use of Humanitarian Use Devices. 2.1. Definitions Humanitarian Use Device (HUD): Treatment or diagnosis of a disease or condition that affects fewer than 8,000 individuals in the United States per year. Humanitarian Device Exemption (HDE): A marketing application for a HUD. An approved HDE authorizes marketing of the HUD. However, a HUD may only be used in facilities having IRB oversight in accordance with 21 CFR Part 56.

VCOM Policy on Humanitarian Use Devices

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