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HUMAN FACTORS PRINCIPLES FOR MEDICAL DEVICE LABELING James R. Callan John W. Gwyme Pacific Science Engineering Group 6310 Greenwich Drive Suite 200 San Diego California 92122-5918 Phone 619 535-1661 Fax 619 535-1665 September 1993 FDA Contract No. 223-89-6022 Dick Sawyer Margaret T. This report focuses on a more general aspect of that process the underlying principles of instruction human factors and cognitive psychology that are involved in desi...
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What is fda 223 89 6022?
FDA 223 89 6022 is a form used by the Food and Drug Administration (FDA) to collect information about adverse events related to medical devices.
Who is required to file fda 223 89 6022?
Manufacturers, importers, and device user facilities are required to file FDA 223 89 6022.
How to fill out fda 223 89 6022?
To fill out FDA 223 89 6022, you need to provide information such as device details, adverse event description, patient information, and any corrective actions taken.
What is the purpose of fda 223 89 6022?
The purpose of FDA 223 89 6022 is to collect data on adverse events associated with medical devices, which helps the FDA evaluate the safety and effectiveness of these devices.
What information must be reported on fda 223 89 6022?
The information reported on FDA 223 89 6022 includes device details, adverse event description, patient information, manufacturer information, and any corrective actions taken.
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