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  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Feature ArticlesFeature Articles

    Expedited Medical Device Submissions in the US: Special 510(k), Abbreviated 510(k), HDE

    US manufacturers seeking clearance for a new device usually submit a Traditional 510(k) application, also known as a Premarket Notification (PMN) or Premarket Approval (PMA) application, to the Food and Drug Administration (FDA). The submission type depends on the device’s regulatory classification under 21 CFR 862–892. Most Class I devices are exempt from the 510(k) requirement; most Class II and a few Class III devices must have a cleared 510(k); and most Class II...
  • Regulatory NewsRegulatory News

    FDA Device Approvals Speedy in First Half of 2014, With Even Faster Approvals Coming Soon

    The US Food and Drug Administration (FDA) approved new medical device products at a pace nearly twice that of the year prior, according to a new report just published by analysts at EP Vantage, the market intelligence branch of Evaluate. New Report EP Vantage's half-year report looked at all medical devices approved by FDA through its Premarket Approval (PMA) pathway and its Humanitarian Device Exemption (HDE) pathway —both used almost exclusively by entirely new devic...
  • 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...
  • FDA Looks to Finally Implement Pediatric Data Requirements for Most Device Submissions

    A new supplemental proposed regulation and related draft guidance document released by the US Food and Drug Administration (FDA) both aim to clarify what is expected of sponsors submitting medical device applications, which are now required to provide information regarding the pediatric subpopulations that suffer from the disease or condition their product is intended to treat. Background In 2007, Congress passed the FDA Amendments Act , a massive piece of legislation ...
  • 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...
  • FDA Grant to Support Neglected Orphan Disease Trials

    The US Food and Drug Administration (FDA) is looking to help fund the development of products intended to treat orphan diseases in areas where no treatments currently exist or the existing treatments are inferior. In a Federal Register post on 3 August, FDA noted the grant money will total $14.1 million, with $4.1 million going toward the development of between five and 10 new awards during the first year and the remaining $10 million supporting continuation awards...
  • Changes Coming to Medical Device Pre-submission Meeting Program

    The US Food and Drug Administration (FDA) has released new draft guidance for medical device manufacturers looking to meet with the agency in advance of submitting a wide range of device applications. Once finalized, the guidance-which formerly only covered Investigational Device Exemption (IDE) applications-will include 510(k) premarket notification applications, premarket approval (PMA) applications and Humanitarian Device Exemption (HDE) applications. FDA explaine...