MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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MD + DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY JULY 2016 | 13 Innovative solutions engineered to your specifc requirements. Realize your vision with the most experienced and dedicated team in the industry. MicroLumen.com For more than two decades, FDA has been categorizing investigational medical de- vices as either Category A (experimental/ investigational) or Category B (nonexperi- mental/investigational) based on the de- vice risk level. This matters because CMS uses that categorization to determine whether the device receives Medicare cov- erage 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 Now, FDA has published draft guidance to update its categorization guidelines to ad- dress devices that don't neatly conform to its original groupings. The previous categoriza- tion protocol, set out in a 1995 Interagency Agreement with CMS (then Health Care Fi- nancing Administration), didn't account for feasibility study devices that, although simi- lar to approved products, have modifications that may impact safety. The old guidelines also didn't offer a way to change device cat- egorization for later studies. The new framework outlines how a cat- egory 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 local- ized review and approval of IDE studies by Medicare Administrative Contractors to a centralized approach. "CMS and FDA recognized the neces- sity to revise their shared understanding regarding the categorization of IDE devices to help ensure that devices will not be pre- cluded from reimbursement due to an in- appropriate reimbursement categorization determination," the draft guidance stated.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 ef- fectiveness 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 The agency's draft guidance concludes with several examples of Category A and B devices, as well as a flowchart to help illus- trate the categorization decision process. —MT 2 Image courtesy of MEJNaK/istocKPHoto.coM FDA Updates IDE Device Categorization for CMS Coverage

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