Division of Clinical Research

Office of the Vice President and Innovation

9/6/2019 – Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff

FDA developed this guidance document to provide clarity to industry and FDA staff about the current review practices for the Humanitarian Device Exemption (HDE) Program. This programmatic guidance addresses commonly asked questions about HDEs and Humanitarian Use Devices (HUDs), including FDA actions on HDE applications, post-approval requirements, and special considerations for devices marketed under the HDE Program. This guidance document reflects changes in the HDE Program resulting from statutory amendments made by the 21st Century Cures Act (Cures Act) and explains the criteria FDA considers to determine if  “probable benefit” has been demonstrated as part of the Agency’s decision-making process regarding marketing authorization for a HUD. This guidance document also reflects amendments made to the HDE provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA Reauthorization Act of 2017 (FDARA).


9/5/2019 – Humanitarian Use Device (HUD) Designations: Guidance for Industry and Food and Drug Administration Staff

This guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation requests to the U.S. Food and Drug Administration’s (FDA or Agency) Office of Orphan Products Development (OOPD). It is also designed to assist FDA reviewers in their evaluation and analysis of HUD designation requests (“HUD requests” or “requests”). Topics addressed in this guidance include:

  • 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 United States per year;
  • how this demonstration varies depending on whether the device is intended for therapeutic or diagnostic purposes;
  • how properties of the device may affect this demonstration; and
  • for the purpose of a HUD request, identifying a medically plausible subset (“orphan subset”) of persons with a given disease or condition that affects or is manifested in more than 8,000 individuals in the United States per year.

This guidance addresses only HUD requests, which are the first step in seeking marketing approval of a HUD. This guidance does not address the second step in this marketing approval process—namely, the submission of a Humanitarian Device Exemption (HDE) application to the Center for Devices and Radiological Health (CDRH) or to the Center for Biologics Evaluation and Research (CBER). For more information on the preparation and submission of HDE applications, see Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff.


9/4/2019 – Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers

This guidance provides recommendations to sponsors, applicants, and contract research organizations regarding internal standard (IS) response variability in chromatographic analytical data submitted in investigational new drug applications, new drug applications, abbreviated new drug applications, biologics license applications, and supplements. Chromatographic analytical methods are commonly used to quantitate analyte concentrations in samples from nonclinical and clinical studies to support regulatory submissions. Depending upon its source, IS response variability may impact the accuracy of analyte concentration measurements. This question and answer (Q&A) document provides the Agency’s current thinking on IS response variability and its potential impact on the accuracy of analyte concentration measurements. This Q&A also suggests approaches to determine whether observed IS response variability is likely to impact the accuracy of the data such that further investigation into the root cause(s) is warranted.

Categories FDA Regulatory
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