In accordance with section 201(h) of the Food, Drug, and Cosmetic Act (FD&C Act), the definition of a medical device is:
“An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other article, including a component part, or accessory which is:
which does not achieve its 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 its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).”
- 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 its primary intended purposes through chemical action within or on the body of man or other animals and
Compliance to international and state regulations is required to ensure that these products (drugs, medical devices, food, and blood components) are reasonably safe and effective for their particular use once they are released to the market.
The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is responsible for regulating the safety and effectiveness of medical devices before and after reaching market. The CDRH helps ensure that patients and providers have timely, continued access to the medical devices they require.
Esco Pharma with its wide range of innovative and turnkey solutions, backed with its four (4) core technologies
enables various industries such as pharmaceuticals, nutraceuticals, and cosmeceuticals to comply with the internationally accredited GMP, as well as, industrial, environmental, and health and safety standards.
- Food and Drug Administration. (2019). How to Determine if Your Product is a Medical Device. Retrieved from: https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device#step1
- Mallis, E. (n.d.). An Introduction to FDA‘s Regulation of Medical Devices [PowerPoint Slides]. U.S. Food and Drug Administration. Retrieved from: https://www.fda.gov/media/123602/download