In addition to IRB approval, most investigational device studies conducted at UF Health locations require additional reviews and workflows before the study is initiated, including:

• FDA Review
• Medicare Pre-Approval for Billing
• Shands Device Procurement Arrangements
• Shands Operating Room Notification
• Device ListServ

FDA Review

• The Food and Drug Administration (FDA) has established multiple classifications and categories for medical devices.
• The classifications are based on the risk the device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device.
• For Significant Risk Device Studies, sponsors are responsible for submitting the study to FDA to obtain approval for the study.
• The FDA reviews the study and issues a letter that indicates what type of class/category the device study falls under.
• The study team should obtain a copy of this FDA letter so it can be forwarded to the IRB, OCR, Shands, Medicare, etc. as required.

Medicare Pre-approval for Billing

• For Significant Risk Device Studies, if a study site plans to bill protocol-required items and services to participants/insurance, Medicare Pre-approval is required for coverage analysis before the study opens to enrollment.
• The Medicare Pre-approval workflow varies depending on the FDA class/category and the date of the inital FDA letter:
  • Pre-approval workflow for Investigational Device Exemption (IDE) Studies
  • Pre-approval workflow for Carotid Artery Stent (CAS) Studies
  • Humanitarian Use Devices (HUD/HDE)

• Other types of device studies do NOT require Medicare pre-approval. These studies fall under the regular Qualifying Studies coverage analysis rules.

Shands Device Procurement Arrangements

• When a study involves a device that has to be purchased, received, or stored by Shands Healthcare, the Shands Supply Chain office should be contacted by the study team and sponsor as early in the start-up process as possible.
• For contact information, see Shands Supply Chain (gatorlink login required).

Shands Operating Room (OR) Notification

• Prior to study start-up, the Shands Operating Rooms (OR) require additional paperwork for study devices that will be used or stored in the OR.
• Please contact Shands OR staff using the Device Trial ListServ and let them know that you are preparing a study that will involve a device that will be used or stored in one or more of their ORs.

Device Trials ListServ

• Study teams must use the Device Trial Listserv Device-Trials-L@lists.ufl.edu for:
  • Investigational Device Exemption (IDE) Studies
  • Carotid Artery Stent (CAS) Studies
  • Coverage with Evidence Development (CED) studies involving an implantable device

• The ListServ should be used prior to any implant/use of the device. This will notify both Shands Hospital and the Research Billing Office (RBO) about these devices, patients, and services so that the device trial charges and claims can be coded and properly processed.

In the email, provide the following information:

• Location of Service*
• Device Name
• Device IDE or CAS number
• Device Cost or provision information (e.g. “provided by sponsor”)
• Study OnCore OCR Number
• Ordering Physician Name
• Patient Name
• Patient Medical Record Number
• Date of Surgery
• Doctor Name
• Service Name

*If the service location includes a Shands OR (e.g. North or South Tower, Florida Surgical Center, Children’s Surgical Center), attach the OR Research Order Form which includes all the required infomation fields.