Some Concepts
What is a Medical Device?
The U.S. Food and Drug Administration (FDA) defines a medical device 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 United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
Understanding Evidence-based Medicine
In development.
Kinds of Evidence About Devices
In development.
RELATED LINKS
- Department of Public Health
- Weill Cornell Medical College
- NewYork-Presbyterian Hospital
- Hospital for Special Surgery
- The Methodist Hospital, Houston, Texas
- Agency for Healthcare Research and Quality (AHRQ)
- Centers for Education and Research on Therapeutics (CERTs) home page
- Food and Drug Administration (FDA)
- Centers for Medicare and Medicaid Services (CMS)
- Cornell Institute for Social and Economic Research (CISER)