Use this form to request the use of medical device(s) in a clinical research study.
Document Details
| Version | Effective Date | Change Notes |
|---|---|---|
| 2.00 | 8/28/2023 | Update to reflect FDA's September 2022 Final Guidance - Policy for Device Software Functions and Mobile Medical Applications. |
| 1.00 | 2/27/2023 | New form to support Hutch IRB. Replaces Device Supplement (0322). |