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HDE means a Humanitarian Device Exemption pursuant to the Safe Medical Devices Act of 1990 and the FDA regulations at 21 CFR Part 814, Subpart H. or a comparable regulatory designation in any other country. HDE Definition | Law Insider lawinsider.com https://.lawinsider.com › dictionary › hde lawinsider.com https://.lawinsider.com › dictionary › hde

An HDE is a type of Pre-Market Approval (PMA) that allows the FDA to grant an exemption from the effectiveness requirements of the PMA regulations. Devices approved with an HDE are referred to as a Humanitarian Use Devices (HUD). Humanitarian Use Device | Research University of Virginia https://research.virginia.edu › irb-hsr › humanitarian-u... University of Virginia https://research.virginia.edu › irb-hsr › humanitarian-u...

Humanitarian Device Exemption (HDE) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

HDE applications are similar to PMAs but are exempt from the effectiveness requirements of a PMA. They still must contain enough scientific evidence to show that the benefits to health of the device outweigh the risks posed to users or patients.

Unlike the 510k process, HDE approval is device approval rather than “clearance” for marketing and distribution. If another equivalent (an actual term used is “comparable”) device is already being legally marketed, then the FDA may not approve an HDE application. HDE Application and 510k Submissions medicaldeviceacademy.com https://medicaldeviceacademy.com › hde medicaldeviceacademy.com https://medicaldeviceacademy.com › hde

HDE applications are similar to PMAs but are exempt from the effectiveness requirements of a PMA. They still must contain enough scientific evidence to show that the benefits to health of the device outweigh the risks posed to users or patients. What is a Humanitarian Device Exemption (HDE)? | Glossary proximacro.com https://.proximacro.com › glossary › humanitarian-... proximacro.com https://.proximacro.com › glossary › humanitarian-...

Humanitarian Device Exemption (HDE): a marketing application for an HUD (Section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). An HDE is exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions.

How is an HDE different from an IDE? An IDE is an exemption that allows a sponsor to ship an investigational device prior to marketing approval; it authorizes the investigational use of the device. A HUD with an approved HDE is approved for marketing.