• Regulatory NewsRegulatory News

    Humanitarian Device Exemptions: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the Humanitarian Device Exemption (HDE) program, reflecting changes made by the 21 st Century Cures Act and further explaining the criteria to determine “probable benefit” related to its decision-making process for humanitarian use devices (HUDs). HUDs are medical devices intended to help treat or diagnose diseases or conditions that affect or are manifested in not more than 8,000 individual...
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    FDA Amends Humanitarian Device Exemption Regulations

    The US Food and Drug Administration (FDA) on Tuesday announced that it is amending its regulations governing humanitarian device exemptions (HDE) to reflect changes brought on by the 21st Century Cures Act . These exemptions provide a pathway for device makers looking to develop medical devices for small patient populations by exempting them from demonstrating a device's effectiveness. Instead, a company must demonstrate that the humanitarian use device (HUD) "will no...
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    In Fight Against Ebola, Device Company Seeks FDA Approval Through Rarely Used Pathway

    In the battle against the Ebola virus, perhaps no weapons have been as sought after as new treatments and diagnostic products to help keep the virus in check and patients safe from harm. But since the start of the outbreak in 2014, one regulatory standard has been an elusive goal for these medical products: Approval. To date, no product has received the full approval of the US Food and Drug Administration (FDA). Now one company is hoping to change that. Seeking Approval ...
  • Regulatory Explainer: Making Sense of Humanitarian Use Devices

    A new draft guidance document issued Monday by the US Food and Drug Administration (FDA) aims to answer some of the common questions surrounding its 2013 guidance document on humanitarian device exemptions (HDEs). What's an HDE, and Why is it Needed? In the US, there are two common pathways for medical products intended for very small populations to reach the market. For pharmaceuticals, this pathway is known as orphan drug designation, and is intended for medicines int...
  • Unique Public Meeting Set to Give One-on-One Advice to Orphan Drug, Device Developers

    Usually when the US Food and Drug Administration (FDA) meets with the public, and in particular members of industry, the meetings taking something of a group-centric approach. With lots of people likely to share similar views or benefit from hearing similar questions, the agency invites the public to listen to short presentations from public speakers before opening the floor to those who have additional, unanswered questions. But in a new and somewhat unusual announcemen...
  • FDA Approves 'World's First Bionic Eye'

    The US Food and Drug Administration (FDA) has announced the approval of a new medical device intended to treat a rare disease population through the use of a retinal implant. FDA Approval The device, Second Sight Medical Products ' Argus II Retinal Prosthesis System, is intended to treat advanced retinitis pigmentosa (RP), a rare genetic eye condition that is marked by progressive damage done to light-sensitive cells that help people to see in low-light conditions an...
  • FDA Finalizes Guidance on Devices Intended for Use in Rare Diseases

    The US Food and Drug Administration (FDA) has announced the release of a new guidance document intended for both its staff and the medical device industry pertaining to the issuance of humanitarian use device (HUD) designations for devices intended to treat rare diseases or conditions. Much like orphan drugs, which are intended to treat conditions that affect fewer than 200,000 people in the US, HUD designations are given to medical devices that are intended to cure, t...