FDA Updates IDE Device Categorization for CMS Coverage

For more than two decades, FDA has been categorizing investigational medical devices as either Category A (experimental/investigational) or Category B (non-experimental/investigational) based on the device risk level. This matters because CMS uses that categorization to determine whether the device receives Medicare coverage or not. Typically, this means that CMS will cover device expenses for a Category B IDE device study but not a Category A IDE study.

Now, FDA has published draft guidance to update its categorization guidelines to address devices that didn't neatly conform to its original groupings. The previous categorization protocol set out in a 1995 Interagency Agreement with CMS (then Health Care Financing Administration) didn't account for feasibility study devices that, though similar to approved products, have modifications that may impact safety. The old guidelines also didn't offer a way to change device categorization for later studies.

The new framework now outlines how a category change would work and FDA also emphasizes that categorization no longer depends on the type of device study being conducted.

The guideline change was also spurred in part by CMS's shift last year from localized review and approval of IDE studies by Medicare Administrative Contractors (MACs) to a centralized approach. 

"CMS and FDA recognized the necessity to revise their shared understanding regarding the categorization of IDE devices to help ensure that devices will not be precluded from reimbursement due to an inappropriate reimbursement categorization determination," the draft guidance stated.

A Category A device may switch to a Category B designation in a later study if an initial study showed positive safety and effectiveness data, or if early phases of a study in a staged IDE approval satisfy safety and effectiveness criteria. Device sponsors who want to ask for a category change should file the request as an IDE supplement, FDA noted.

The agency's draft guidance concludes with several examples of Category A and B devices, as well as a flowchart to help illustrate the categorization decision process.

Below are FDA's new categorization guidelines:

"Category A: Experimental

"42 CFR 405.201(b): "...a device for which 'absolute risk' of the device types 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." FDA intends to consider a device to be in Category A if one or more of the following criteria are met:  

"o No PMA approval, 510(k) clearance or de novo request has been granted for the proposed device or similar devices, and non-clinical and/or clinical data on the proposed device do not resolve initial questions of safety and effectiveness.

"o The proposed device has different characteristics compared to a legally marketed device; and information related to the marketed device does not resolve initial questions of safety and effectiveness for the proposed device. Available non-clinical and/or clinical data on  the proposed device also do not resolve these questions. 

"o The proposed device is being studied for a new indication or new intended use for which information from the proposed or similar device related to the previous indication does not resolve initial questions of safety and effectiveness. Available non-clinical and/or clinical data on the proposed device relative to the new indication or intended use also do not resolve these questions.

"Category B: Nonexperimental/Investigational

"42 CFR 405.201(b): "...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 FDA premarket approval or clearance for that device type.". FDA intends to consider a device to be in Category B if one or more of the following criteria are met:

"o No PMA approval, 510(k) clearance or de novo request has been granted for the proposed device or similar devices; however, available clinical data (e.g., feasibility study data) and/or non-clinical data for the proposed device or a similar device resolve the initial questions of safety and effectiveness.

"o The proposed device has similar characteristics compared to a legally marketed device, and information related to the marketed device resolves the initial questions of safety and effectiveness for the proposed device. Additional non-clinical and/or clinical data on the proposed device may have been used in conjunction with the leveraged information to resolve these questions.

"o The proposed device is being studied for a new indication or new intended use; however, information from the proposed or similar device related to the previous indication resolves the initial questions of safety and effectiveness. Additional non-clinical and/or clinical data on the proposed device may have been used in conjunction with the leveraged information to resolve these questions."

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