FORM FDA 3500
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People also ask
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What is the MedWatch mandatory reporting form?
The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients. -
Is MedWatch reporting mandatory?
The law requires mandatory reporting to the Food and Drug Administration (FDA) of serious adverse events for dietary supplements using FDA Form 3500A. The authority is 21 U.S.C. 379aa-1(a) (3), (b) (1) and/or section 761(a) (3) and (b) (1) of the FD&C Act. -
When should a MedWatch form be submitted to the FDA?
User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown. User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33. -
How do I file an adverse event with FDA?
Call 1-800-FDA-1088 to report by telephone. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (Send only page 1 plus any continuation pages - do not send instruction pages). -
What is FDA Form 3500?
Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers. -
When should a MedWatch form be submitted?
PURPOSE: To provide clear guidance on the required reporting of serious adverse effects to the FDA MedWatch. TERMS: All instances involving medication errors and/or serious adverse effects due to an infusion must be reported to the FDA Watch within seven (7) calendar days of onset. -
How do I report to FDA MedWatch?
If you need information or if you have questions or comments about a medical product, please call the FDA's toll-free information line, 1-888-INFO-FDA (that's 1-888-463-6332) and Press 2 to report to MedWatch or for instructions. -
What is the difference between MedWatch Form 3500 and 3500A?
The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.
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