FDA and CMS Parallel Reviews of Devices to Continue

Friday, October 21, 2016

Source: RAPS

A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday.

The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or the granting of a de novo and a national coverage determination (NCD) by CMS.

Currently, CMS takes six to nine months, depending on whether an external technology assessment is needed, to make a national coverage determination. However, by beginning their assessment while FDA is reviewing the device, that time can be cut to just a couple of months.

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