Medical Device Initiative


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  • Payor Coverage of Medical Devices Approved Under FDA's Humanitarian Device Exemption

    Patients with rare medical diseases sometimes lack effective medical treatments for their conditions.  In these cases, the U.S. Food and Drug Administration may use a Humanitarian Device Exemption, or HDE, to bring new technologies more quickly to such patients in dire circumstances. But some health care payors—including Medicare, Medicaid, and insurance companies—do not always reimburse patients... Read More

  • Patient Access to High-Risk Devices for Unmet Medical Needs

    On Thursday, January 30, The Pew Charitable Trusts will hold an interactive conference with leading experts from FDA, the Centers for Medicare & Medicaid Services (CMS), the medical device industry, patients, consumers, private payors and other key health policy stakeholders to explore patient access to devices for unmet medical needs. Read More

  • The Hill: Coming Soon: IDs to Track Medical Devices

    Congressional hearings on health care can be contentious, but the story will be different today (November 19), when the bipartisan House Medical Technology Caucus convenes a forum with representatives from the U.S. Food and Drug Administration , manufacturers, and hospitals to discuss how new tracking codes for medical devices can enhance recalls and assessments of heart stents, glucose monitors,... Read More

Media Contact

Linda Paris

Officer, Communications