Device Studies

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 initial 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.

Shands Operating Room (OR) Notification

• For details, see Use Device ListServ.

Device Trials ListServ

• Study teams must use the Device Trial Listserv prior to any implant/use of the following types of devices:
  • Investigational Device Exemption (IDE) Studies
  • Carotid Artery Stent (CAS) Studies
  • Coverage with Evidence Development (CED) studies involving an implantable device
• For details, see Use Device ListServ.