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MedWatcher: The Food and Drug Administration Medical Products Reporting Program 09100291 SUPPORTING STATEMENTTerms of Clearance: none A. Justification1. Circumstances Making the Collection of Information
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What is MedWatch: The Food and Drug Administration Medical Products Reporting Program Form?

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Medwatch form is used to report adverse events, product problems, and product use errors for FDA-regulated products such as food.
Manufacturers, distributors, and importers of FDA-regulated products are required to file medwatch form for food.
Medwatch form can be filled out online on the FDA website or submitted via mail or fax using the provided instructions.
The purpose of medwatch form is to gather information about adverse events, product problems, and product use errors to help the FDA monitor the safety of food products.
Information such as the product name, lot number, date of purchase, adverse event details, and contact information of the reporter must be reported on medwatch form for food.
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