When submitting a new device study to Schulman, certain additional information must be provided to ensure a thorough, timely review. For Schulman’s standard study submission requirements, review how to Submit a Study.
For all device studies, include the device brochure/labeling with your submission.
Study Involves a Device Subject to IDE Regulations
- Letter from the Sponsor/Principal Investigator stating the device is non-significant risk (NSR) or significant risk (SR), with supporting information for the determination
- If the FDA has provided the device manufacturer with a written determination that the device is a SR or NSR device, the FDA communication should be supplied
Study Involves a Device Not Subject to IDE Regulations
- Letter from the Sponsor/Principal Investigator describing why the device is exempt from IDE regulations under 21 CFR 812.2(c) or providing another reason why the study is not subject to IDE regulations (i.e., not a study of device safety or efficacy)
- If the FDA has provided the device manufacturer with a written determination that no IDE is required, the FDA communication should be supplied
Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE) Submission
For HUD/HDE submissions, follow the general guidance and forms available on our website to Submit a Study. Schulman’s forms are written for use with a research study; complete the applicable forms to the extent possible and indicate “not applicable” as necessary.
In addition to the general guidance and submission requirements, the following should be included with an HUD/HDE submission:
- Letters from those physicians who have or are applying for clinical privileges to deploy the device, setting forth the indications and rationale for use of the device.
- A consent document that has been developed for use with patients, which describes the device and the procedure for device use (e.g., surgical consent). Prepare a consent for the humanitarian use of the device and submit it, in Word format, to Schulman for review. Alternatively, a Patient Booklet may be accepted by the Board.
- The procedure for tracking the devices and the required reporting to Schulman, i.e. when a device is deployed and when an adverse event occurs.
- Confirmation your institution will report adverse events to the FDA.
- History of adverse events occurring during/following previous use of the device, if the HUD was previously utilized under another IRB’s oversight.
- Research Site Submission Form (SmartForm also available) – Schulman’s forms are written for use with a research study; complete the applicable forms to the extent possible and indicate “not applicable” as necessary. Items 28-31 must be completed for each investigator who has or will have privileges to deploy the device.
- A letter indicating you are requesting review of a Humanitarian Use Device.
- CVs and medical licenses of all the physicians who are competent to use the device and who may possibly use the device.
- Product brochures and labeling for the device – The labeling should incorporate discussion of the potential risk and benefits of the device as well as any procedures associated with the use of the HUD/HDE. Schulman requires assurance that the labeling states the device is a humanitarian use device and, although authorized for use by Federal Law, the effectiveness of the device for a specific indication has not been demonstrated.
- FDA correspondence describing/confirming status of HUD/HDE approval.