Devices

2 Humanitarian Use Guidances

FDA has published two guidances relating to the Humanitarian Device Exemption (HDE) Program. The first guidance, Humanitarian Device Exemption Program, is intended to clarify the current review practices for the HDE program. The document addresses commonly asked questions about HDEs and humanitarian use devices (HUD), including FDA actions on HDE applications, post-approval requirements, and special considerations for devices marketed under the HDE program. FDA says the guidance reflects changes made in the 21^st Century Cures Act and explains the criteria the agency considers to determine if “probable benefit” has been demonstrated as part of the agency decision-making process.

The guidance supercedes one issued in 2010 and contains an Introduction, Background, Scope, HUD Designations and HDE Applications, FDA Review of HDE Applications, Assessing Probable Benefit and Risk in an HDE Application, Post-Approval Requirements, Special Considerations for Devices Marketed Under an HDE, Paperwork Reduction Act of 1995, and three appendices.

The second guidance, Humanitarian Use Device Designations, is intended to assist applicants in preparing and submitting HUD designation requests for FDA’s orphan products development program. Topics addressed include (1) demonstrating in HUD requests that the device is designed to treat or diagnose a disease or condition that affects or is manifested in not more than 8,000 individuals in the U.S. per year; (2) how this demonstration varies depending on whether the device is intended for therapeutic or diagnostic purposes; (3) how properties of the device may affect this demonstration; and (4) for the purpose of a HUD request, identifying a medically plausible subset of persons with a given disease or condition that affects or is manifested in more than 8,000 individuals in the U.S. per year.

The document includes Introduction, Background, Contents of HUD Requests, Pediatric Considerations, and HUD Decision Flowchart.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome