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Submit a Device Study

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, refer to the federal regulations, guidance and Schulman’s submission forms.  Schulman IRB provides HUD-specific forms for initial submissions, ongoing review, change of clinician, MRR reporting, and off-label use.

For specific questions regarding HUD submissions, please contact Schulman’s Submissions Team.

For investigational use of a HUD, please follow the IDE submission process. For more information, see the Study Involves a Device Subject to IDE Regulations section above.

Initial Review

Initial review of HUDs requires full board review. The following should be included with an initial HUD/HDE submission:

  • Completed HUD Deployment Initial Submission SmartForm (registration required)
  • Copy of FDA approval letter (approval order granted by FDA for HUD)
  • Clinician 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. For reference, Schulman offers a Clinician Letter Template.
    • Each clinician who may be involved in deploying the HUD must provide a Clinician Letter, which should include the following:
      • Screening procedures
      • HUD-specific procedures
      • Summary of past deployments of the device
      • Patient follow-up visits, tests, and/or procedures
  • Product labeling of the device/Instructions for Use
  • Patient Information Brochure or Packet (if applicable)
  • Sponsor’s most recent annual HDE report to FDA
  • Procedure for tracking the devices and the required reporting to Schulman (i.e. when a device is deployed, when an adverse event occurs, etc.)
  • Confirmation Clinician’s institution will report adverse events to the FDA
  • Any current or proposed Informed Consent(s) in Microsoft Word format (if applicable)
    • Note: Schulman IRB does not need to review surgical or procedural consent forms.
  • CVs of all Clinicians seeking clinical privileges to deploy the device (CV must reflect experience and required training and be signed/dated within past 2 years)
  • Copy of Clinician’s current medical/professional license (Canada, Mississippi and Puerto Rico sites only)
  • Deferral of IRB Oversight letter or Cover Page (if not currently on file)

Change in Clinician

Any new Clinician who plans to deploy the HUD must be approved by the IRB. To submit a change in Clinician, please provide:

  • Completed Change/Addition of Clinician for HUD SmartForm (registration required)
  • Signed/dated CV within the past 2 years (if not already on file with Schulman)
  • Clinician Letters from those physicians applying for clinical privileges to deploy the device, setting forth the indications and rationale for use of the device
  • Documentation of HUD-specific training required by the HDE holder (per Instructions for Use or the FDA’s HDE approval letter)

Device Modifications/HDE Amendments/Revisions

HUD design changes should be reported to the IRB. Please submit any amendments or revisions to the HDE, including a new FDA approval letter and updated product labeling/instructions for use (if applicable) using the Product Safety SmartForm (registration required).

Continuing Review

Continuing review of HUDs occurs at least annually and may be conducted by expedited review, unless otherwise directed by the board. To submit a continuing review report for an HUD, please submit the HUD Status Report SmartForm (registration required).

All HDE holders must submit copies of any annual reports submitted to the FDA. Clinicians will be prompted to provide the annual report with the continuing review submission.

Off-Label Use of HUD

Schulman requires reports of off-label use of HUDs within 5 working days. Use the Ongoing Review SmartForm (registration required) or Off-Label Use of HUD Report Form to report any off-label use.

Medical Device Reporting (MDR) for HUD

Device user facilities and manufacturers are required to submit medical device reports to FDA and to the IRB of record when:

  • The HUD may have caused or contributed to a death or serious injury
  • The HUD has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur

Use the MDR Submission for HUD Report SmartForm (registration required—accessible via Product Safety SmartForm) or HUD MDR Reporting Form to submit a report.