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1209.0829 CFR Ch. X (7118 Edition) cluding the identification of speakers, shall be furnished subject to the payment of duplication costs in accordance with the schedule of fees set forth in 1208.06
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Pharmaceutical companies that manufacture, process, pack, or distribute prescription and over-the-counter drugs in the United States.
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21 CFR 2045 is a regulation set forth by the Food and Drug Administration (FDA) that pertains to the filing of certain reports related to medical devices.
Manufacturers, importers, and device user facilities are required to file 21 CFR 2045 reports.
To fill out 21 CFR 2045, the reporting entity must provide specific information about the medical device, adverse events, and other relevant data.
The purpose of 21 CFR 2045 is to ensure the safety and effectiveness of medical devices by collecting and analyzing adverse event reports.
Information such as the type of device, the manufacturer, the adverse event, and any corrective actions taken must be reported on 21 CFR 2045.
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