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Form Approved OMB No. 0910-0025 Expiration Date January 31 2017 FORM FDA 3632 2/14 Guide for Preparing Product Reports for Lasers and Products Containing Lasers Public reporting burden for this collection of information is estimated to average 24 hours per response including the time for reviewing instructions searching existing data sources gathering and maintaining the data needed and completing and reviewing the collection of information. Send...
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The FDA 3632 form is a form used to report adverse events associated with medical devices to the Food and Drug Administration.
Manufacturers, importers, and distributors of medical devices are required to file the FDA 3632 form.
To fill out the FDA 3632 form, you need to provide information about the medical device, the adverse event, any related products, and contact information.
The purpose of the FDA 3632 form is to ensure the timely reporting and investigation of adverse events associated with medical devices in order to enhance patient safety.
The FDA 3632 form requires information such as the type of medical device, the adverse event description, patient demographics, device information, and any additional relevant details.
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