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How long do you have to report an adverse event?

Unexpected fatal or life-threatening suspected adverse reactions represent especially important safety information and must be reported to FDA as soon as possible but no later than 7 calendar days following the sponsors initial receipt of the information.

Who is required to report to MedWatch?

MedWatch Form FDA 3500A (Mandatory Reporting) Form FDA 3500A is used by manufacturers, user facilities, distributers, importers, and other respondents subject to mandatory reporting. Mandatory reporting of adverse events or product experiences is governed by statute and often codified in Agency regulations.

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.

What is the FDA reporting system called?

What is FAERS? 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 are the timelines for medical device adverse event reporting in the US?

Regulations require device manufacturers to report to FDA (1) within 30 calendar days of acquiring information that reasonably suggests one of their devices may have caused or contributed to a death, serious injury, or malfunction and (2) within 5 working days if an event requires action other than routine maintenance

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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 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.

When should a medical device report be submitted?

You must submit a report to the manufacturer of the device no later than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility.

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 should I not report to MedWatch?

Patients should not report com- mon, less serious adverse events cited in the prescribing information, such as nausea or constipation, to MedWatch. In addition, patients should not report problems associated with vaccines, investigational drugs or biologics, or websites selling illegal products.

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