What is a medical device?
According to the US FDA, a medical device is defined as an instrument or a reagent intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans or animals1. The definition of in vitro diagnostic medical devices as stated by regulatory bodies in the European Union, Canada, and other nations around the world are similiar.
What does this mean to a Waters IVD medical device customer?
Waters Corporation manufactures IVD medical devices that offer clinical diagnostic laboratories an alternative to LC-MS/MS systems manufactured for clinical research use only. Research Use Only (RUO) instruments and reagents are not intended for clinical diagnostic use.
In the United States, the design, manufacture and servicing of medical devices are governed by 21 CFR Part 820, Quality System Regulation. These federal regulations are intended to ensure that finished medical devices will be safe, effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act.
In Europe and Canada, the design, manufacture and servicing of medical devices are governed by ISO 13485:2003, Medical Devices - Quality management systems-Requirements for regulatory purposes. Depending on the type of activities performed by the manufacturer, quality system requirements include controls for the design manufacture, packaging labeling, storage, installation and servicing of all finished medical devices.
Waters quality management system complies with both the U.S. Quality System Regulation and ISO 13485:2003, which is not a requirement when supplying LC-MS/MS systems for research purposes.
1. "Is The Product A Medical Device?". U.S. Department of Health and Human Services -. U.S. Food and Drug Administration. 10 June 2014. Retrieved 15 June 2014