FDA, CMS: Second Parallel Review Decision Ever for NGS Test
By Michael Mezher -
Published 01 December 2017
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test.
Categories: News, US, FDA, In vitro diagnostics, Reimbursement, Submission and registration
Tags: Parallel Review, CMS, FoundationOne CDx, Breakthrough Device
Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices
By Alexander Gaffney, RAC -
Published 27 April 2015
Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way.
Categories: News, US, CDRH, Medical Devices
Tags: Breakthrough Therapy, Breakthrough Device, Breakthrough Technology, Advancing Breakthrough Devices for Patients Act, Congress, Senate, Legislation, Bill