Support for Drug & Device Studies

Human Research Regulatory Affairs Support for Drug & Device Studies
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Human Research Regulatory Affairs Support for Drug & Device Studies

Device trials can be complicated. NYU School of Medicine’s Human Research Regulatory Affairs has developed a device study initial guidance document. Alert us when participation in such a trial is contemplated.

Device studies may require approval by the Inventory Control Board, New Technologies, and Value Analysis Committee, depending on the nature and location of the study. Please talk with your designated clinical research management coordinator to ensure submissions are made in a timely manner.

Device Studies Requiring Centers for Medicare and Medicaid Services Preapproval

All Category A and B device trials that include plans to bill routine care costs to Medicare or other insurance payors must be submitted to the Centers for Medicare and Medicaid Services. Category A and B device trials are defined as follows:

  • A Category A, or experimental, device refers to a device for which “absolute risk” of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective. 
  • A Category B, or nonexperimental/investigational, device refers to a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved) or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained U.S. Food and Drug Administration premarket approval or clearance for that device type.

The Centers for Medicare and Medicaid Services (CMS) evaluates your request to bill it for the identified routine care services associated with the clinical trial. The CMS also confirms routine care costs for all studies regardless of medical insurance payor. 

Additional Considerations

We ask that investigators consider the following questions:

  • Is the proposed device, or a device similar to the proposed device, legally marked? If not, the device is experimental for the population or indication.
  • If nonexperimental, does it have an investigational device exemption and Category B designation? For example, if the device was previously designated as Category A (experimental), but the initial questions of safety and effectiveness of the device have been resolved, the FDA will change the category from A to B. 
  • Is the sponsor providing the device?
  • If the device is experimental, does the company provide billing or reimbursement specialists to help determine appropriate billing codes and provide information for submission to the local Medicare carrier?
  • Is the device being provided at no cost or at some other rate, such as standard market value or Medicare-accepted rate?
  • If the device has to be purchased, is that done through standard hospital purchasing or does some special process need to be set up?
  • Have appropriate billing codes for the device already been established in the hospital system? 
  • If the device is to be billed to insurance or Medicare, have it been covered before? If not, the hospital may not accept billing other than to the study account.

Call us at 212-263-4110 with any additional questions.