Device Trials & Humanitarian Use Devices

Using the FDA definition, Devices are defined as:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

-Recognized in the official National Formulary, or the USP
-Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease
-Intended to affect the structure or any function of the body
-Does not achieve any of its primary intended purposes through chemical action within or on the body
-Is not dependent upon being metabolized for the achievement of any of its primary intended purposes

 (As defined by the Federal Food, Drug, and Cosmetic Act, 21 United States Code [321] (h))

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the US per year.

(As found in 21 CFR 814 Subpart H-Humanitarian Use Devices)

Questions?  Need to request training or education? Please contact clinicalresearch@partners.org or Kele Piper in the MGH Research Compliance Office.

Guidance

Device Trials at MGH

Humanitarian Use Devices at MGH