• Regulatory NewsRegulatory News

    FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings

    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. The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence ...
  • Regulatory NewsRegulatory News

    FDA Announces First-Ever Approval Under CMS Parallel Review Program

    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. Background The pilot program, known as Parallel Review , was conceived in October 2011 as a way to allow companies to get their products from an investigational stage to reimbursement ...