Helpful Tips About Your Glucose Meter (cont.)
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.
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.
Reporting Problems with Glucose Meters to FDA
FDA learns about problems with medical products through the MedWatch program.
Consumers can report problems with medical devices, including glucose meters,
Portions of the above information has been provided with the kind permission of the Food and Drug Administration.
Last Editorial Review: 5/21/2002
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