Search Results for Parallel Review

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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

FDA and CMS Parallel Reviews of Devices to Continue By Michael Mezher - Published 21 October 2016

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.

Categories: News, US, FDA, Clinical, Medical Devices, Reimbursement, Submission and registration

Tags: Parallel review, National coverage determination, Centers for Medicare & Medicaid Services, CMS

FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings By Michael Mezher - Published 23 February 2016

The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices.

Categories: News, US, CDRH, Clinical, Communication, Medical Devices, Reimbursement, Submission and registration

Tags: Parallel Review Pilot Program, National Coverage Decision, NCD, Reimbursement

FDA Announces First-Ever Approval Under CMS Parallel Review Program By Alexander Gaffney, RAC - Published 12 August 2014

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have jointly approved the first-ever product through a parallel review pilot program that seeks to accelerate the process by which device products obtain government reimbursement decisions.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Reimbursement, Submission and registration

Tags: CMS, FDA CMS Pilot, Parallel Review, National Coverage Determination, NCD,