The Definition of Medical Device

Medical Device Regulation

First Post: The Definition of Medical Device. May 24 2014

This blog is entirely dedicated to medical devices and their related regulations and quality systems. Medical devices are regulated by various agencies all over the world. For example, in the US, the Food and Drug Administration (FDA) has the power and authority to regulate medical devices manufactured and sold in the United States. This blog will focus mainly on US. However, this blog also talk about other countries’ regulations like Canada, European Union, Australia, China, Japan, Korea, some South American countries. 

I will try to use literature, article and publication to substantiate each statement if possible. Afterall, this blog is about regulations and guidelines and must be substantiated with facts and data.

What is Medical Device?

Per FDA, A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is (1):

·        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 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 any of its primary intended purposes." (1)

 

(1)---What is Medical Device? USFDA website, www.fda.gov, page last updated: 04/22/2014

 About myself: I am KC Low and home based in San Francisco, CA. I had been working as a consultant and manager in the biopharmaceutical and medical device industries for the past 25 years and love to use this blog to further improve my knowledge on medical device regulation and quality system. That is why I am doing this blog.  I had degrees in mathematics, biochemistry, business administration, chemistry and regulatory affairs. I hold 10 US patents on biopolymers.

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.