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Which is the FDA reporting system for adverse events?

The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA.

What is the FDA MedWatch Program?

MedWatch, the FDA's medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as: Prescription and over-the-counter medicines.

What is FDA 3500A form?

Form FDA 3500A - Mandatory Reporting and Instructions for Completing Form FDA 3500A. Mandatory reporting For use by IND reporters, manufacturers, distributors, importers, user facilities personnel.

What is the purpose of the MedWatch form and where can it be found?

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.

What is FDA 3500A?

\u2022 A user facility is required to report a device-related death or a device-related serious injury to the manufacturer and to report a device-related death to FDA. \u2022 Manufacturers must prepare and submit a complete Form FDA 3500A for each suspect device.

medwatch 3500 form

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How do I submit a MedWatch form?

Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

What is a FDA MedWatch 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.

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.

What type of information is required on Form FDA 3500A?

List and provide product names and therapy dates for any other medical products (drugs, biologics, including human cells, tissues, and cellular and tissue-based products (HCT/Ps), or medical devices, etc.) that the patient was using at the time of the event.

What is Form FDA 3500B?

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.

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