Where do I send my FDA form 3500A?

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.

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What is a MedWatch form 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.

What is a 15 day IND report?

Unexpected serious suspected adverse reactions and observations from animal studies suggesting significant risk to human subjects must be reported to FDA as soon as possible but no later than within 15 calendar days following the sponsor’s initial receipt of the information.

How do I file an IND safety report to the FDA?

To submit IND ICSRs electronically, either through the ESG or SRP, the sponsor needs to have an account with FDA. To create an account, the sponsor should contact the FAERS electronic submissions coordinator at [email protected].

How can a sponsor submit an IND safety report?

The sponsor must submit each IND safety report in a narrative format or on FDA Form 3500A or in an electronic format that FDA can process, review, and archive.

What is needed for an IND submission?

Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 certifying that the study is registered in the national database of clinical trials (FDA Form 3674).

What mode of submission is used to submit IND application reports to FDA?

Who is responsible for submission of safety reports to the regulatory authorities?

Safety Reporting The sponsor of a clinical trial is responsible for the ongoing safety evaluation of the investigational product or study intervention. Safety reports are submitted to the regulatory agency, the ethics committee, oversight groups, and the sponsor throughout the lifecycle of a trial.

What qualifies as a Serious Adverse Event?

Serious adverse event or serious suspected adverse reaction: Death. A life-threatening adverse event. Inpatient hospitalization, or prolonged of existing hospitalization. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. A congenital anomaly/birth defect.

What qualifies as an adverse event?

Listen to pronunciation. (AD-vers eh-VENT) An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse events may be mild, moderate, or severe, and may be caused by something other than the drug or therapy being given.

Where can I find the new FDA 3500B form?

Information for Consumers, Patients and Caregivers: FDA has a voluntary reporting form, Form FDA 3500B, that is customized to make the completion of the form by non-health professionals or consumers easier. You may continue to use this Form FDA 3500, but can find a link to the new consumer form on the MedWatch homepage: www.fda.gov/medwatch.

Who is required to report medical devices to the FDA?

Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers). Mandatory Reporting for Manufacturers, Importers and Device User Facilities (Form FDA 3500A):

How do I submit a 3500B to MedWatch?

What is form 3500 used for?

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.