NEW YORK — The US Food and Drug Administration on Thursday released a final guidance document to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation requests.
FDA reviewers use the document when they evaluate and analyze such requests.
According to the FDA's website, the guidance document addresses a number of issues related to submissions, including demonstrating that a device is designed to treat or diagnose a disease or condition that affects up to 8,000 people in the US each year.
The FDA said that its guidance document addresses how this demonstration varies depending on whether the device is intended for therapeutic or diagnostic purposes, and describes how properties of the device may affect this demonstration.
The updated guidance document further addresses identification of a "medically plausible subset of persons with a given disease or condition that affects or is manifested in more than 8,000" people in the US each year, the FDA said.
The agency noted that the guidance addresses only HUD requests, which is the first step in seeking marketing approval for such a device. The HUD-related guidance does not address the second step in the marketing approval process, the submission of a Humanitarian Device Exemption (HDE) application.
On Thursday, the FDA had also issued a final guidance document to provide updated information about the application process for its HDE program, firming up a draft guidance for this regulatory pathway issued in June 2018.