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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 is a MedWatch form?

\u201cA MedWatch Form is used to report an adverse or sentinel event to MedWatch\u201d - the United States Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program. Founded in 1993, the MedWatch program was established by the FDA to help collect data on adverse events in the healthcare industry.

What information should be reported to MedWatch?

Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.

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 is MedWatch in pharmacy?

MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as: Prescription and over-the-counter medicines. Biologics such as blood components, blood/plasma derivatives and gene therapies. Medical devices such as hearing aids breast pumps, and pacemakers.

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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.

How accurate is MedWatch?

More than 25% of the names of reported suspect products were inaccurate, and 31% of suspect product start dates were inaccurate. Higher levels of completion and accuracy were associated with reports filed closer to the date when the adverse event was observed.

How do you report an adverse drug reaction?

If you prefer, you may contact the U.S. Food & Drug Administration (FDA) directly. www.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.

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?

Device User Facility Reporting Requirements 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.

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