What is a Medical Device?

The role of medical devices in healthcare is essential; however, defining what constitutes a medical device is not always as clear cut as it may seem.

29 May 2013

Medical devices help save the lives of patients every day. The role of medical devices in healthcare is essential; however, defining what constitutes a medical device is not always as clear cut as it may seem.

For example, Medical Devices as defined by the FDA's Food, Drug and Cosmetic Act are instruments, apparatus, implements, machines, contrivances, implants, in vitro reagents, other similar or related articles, including any component, parts, or accessories, which are:

  1. Recognized in the official NF/USP or any supplement to them;
  2. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man; or
  3. Intended to affect the structure or any function of the body of man, and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Unlike in Europe and Canada, the FDA's definition does not specifically mention software. The European definition includes the phrase "including software necessary for its proper application...."

However, do not get fooled into thinking the FDA does not require software used in a medical device to be validated. They do require software to be validated.

Our experts are available to comment on your question(s). Feel free to leave a question below and one of our medical device experts will get back to you.

Today's expert blogger is Lindsay Donald. Lindsay is the Vice President of Intertek Health and Environmental's Pharmaceuticals & Healthcare Consulting Group. He has over 30 years of drug development experience within pharmaceutical, biotechnology and contract research organizations. Lindsay is intimately involved with the strategic planning, design and implementation of drug development programs for clients. Nonclinical and clinical safety data in support of regulatory filings are critically evaluated and he represents clients with various international regulatory agencies including the Food & Drug Administration, Health Canada and the European Medicines Agency.