How FDA Regulates Glucose Meters
FDA reviews all glucose meters and test strips before they can be marketed to the public. This FDA "premarket" review process requires the manufacturer of the meter to show that the meter system provides acceptable accuracy and consistency of glucose measurement at high, medium and low levels of glucose as compared to glucose meters already being sold. The quality of software is an increasingly important feature of glucose meters since it controls the testing and data storage and controls the displays that the user sees and uses when testing.
FDA also considers possible interference from over-the-counter medications, prescription medications, and vitamin supplements.
FDA also asks for data showing how well the meter has performed during actual use (a type of human factors study). These studies ensure that users understand the labeling, achieve good results, and avoid experiencing problems that could affect their health.
For an outline of the FDA review process for glucose meters, use the following link:
Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology (Draft Document)
http://www.fda.gov/cdrh/ode/gluc.html
For information about the application of human factors to the design of medical devices, use the following link:
Medical Device Use Safety: Incorporating Human Factors Engineering into Risk Management
http://www.fda.gov/cdrh/humfac/1497.pdf
FDA quality system regulations require that manufacturers who make glucose meters follow the same quality standards every time. In this way, users can be assured that new meters and strips perform as well as older models.
FDA's responsibility for medical devices does not end when the devices enters the market. To monitor the quality of products, FDA routinely inspects manufacturing facilities. It also receives information from the manufacturers, health providers and the general public through the MedWatch system.
