Subject: Investigational Devices

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to require that Investigators must comply with all applicable regulations pertaining to investigational devices, and that all proposed uses of investigational devices must be reviewed and approved by the IRB as defined by Federal regulations.

1. Investigational Device Exemption (IDE) Studies.
   1. The IRB will review and have authority to approve, require modifications in (to secure approval), or disapprove all clinical investigations involving investigational devices, as defined by Federal regulations. ^[1], ^[2]
   2. The IRB will conduct its continuing review of an investigation in accordance with IRB Policy III.I. ^[3], ^[4] The Investigator must provide evidence that the sponsor has obtained an Investigational Device Exemption (IDE) (including a treatment IDE) ^[5], unless the study is exempt from IDE requirements, as defined by Federal regulations. ^[6]
   3. The study may begin thirty days after FDA receives the application for the investigation of a device other than a banned device, unless FDA notifies the sponsor that the investigation may not begin; or when FDA approves, by order, an IDE for the investigation. ^[7]
2. Non-Significant Risk (NSR) Device Studies.

   If the IRB determines that an investigation presented for approval as a non-significant risk device study, ^[8] involves a significant risk device study, it will notify the Investigator and, where appropriate, the sponsor. A sponsor may not begin the investigation except as provided in Section I above (with an FDA-approved IDE). ^[9] If the IRB determines that the study is a non-significant risk device study, an IDE will not be required. ^[10]

3. Custom Devices.

   A custom device is exempt from the requirement for an IDE, unless the device is being used to determine safety or effectiveness for commercial distribution. ^[11], ^[12]

^[1] 21 CFR 812.42

^[2] 21 CFR 812.62

^[3] 21 CFR 812.64

^[4] IRB Policy III.I

^[5] 21 CFR 812.36

^[6] 21 CFR 812.2

^[7] 21 CFR 812.30(a)

^[8] 21 CFR 812.2(b)(1)(ii)

^[9] 21 CFR 812.66

^[10] 21 CFR 812.2 (b)(1)(ii)

^[11] 21 CFR 812.2 (c)(7)

^[12] 21 CFR 812.3 (b)