FDA 3500A 2019 free printable template

Identify each report as device 1 device 2 etc. Form FDA 3500A for each different suspect device. Each 3500A will be given a separate Manufacturer Report Number. If the event involves more than one suspect medical device complete all applicable sections of Form FDA 3500A for the first device and a separate section D Suspect Medical Device and Blocks F9 F10 F13 and F14 for each additional device. Print Next Page Reset Form U.S. Department of Health and Human Services Food and Drug...

How to fill out FDA 3500A

How to fill out FDA 3500A

1. Obtain the FDA Form 3500A from the FDA's website or your healthcare facility.
2. Fill in the patient's information including name, address, and contact details.
3. Provide details of the adverse event, including the date it occurred and a description of the event.
4. Complete the section on the product involved, including the name, manufacturer, and lot number.
5. Indicate the outcome of the adverse event (recovered, ongoing, etc.).
6. Provide information about the reporter (healthcare professional, manufacturer, etc.).
7. Sign and date the form.
8. Submit the completed form to the FDA electronically or by mail.

Who needs FDA 3500A?

1. Healthcare professionals who report adverse events related to medications or medical devices.
2. Manufacturers of drugs or devices that need to submit adverse event reports.
3. Patients or consumers who experience adverse events and wish to report them.

People Also Ask about

Is MedWatch 3500A mandatory?

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 MedWatch 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.

What should be reported to MedWatch?

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.

What is the difference between MedWatch 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.

What is FDA 3500A?

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. • Manufacturers must prepare and submit a complete Form FDA 3500A for each suspect device.

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What is FDA 3500A?

FDA 3500A is a form used for the mandatory reporting of adverse events related to drugs and biologics. It is primarily used by manufacturers to report adverse events to the FDA as part of post-marketing surveillance.

Who is required to file FDA 3500A?

FDA 3500A must be filed by manufacturers of drugs and biologics, as well as by distributors and healthcare providers who suspect a product may have caused an adverse event.

How to fill out FDA 3500A?

To fill out FDA 3500A, one needs to provide comprehensive details about the adverse event, including patient information, event description, product information, and any relevant clinical history. It is important to follow the guidelines provided by the FDA for accurate reporting.

What is the purpose of FDA 3500A?

The purpose of FDA 3500A is to collect information on adverse events, which helps the FDA monitor the safety of drugs and biologics and take regulatory actions when necessary to protect public health.

What information must be reported on FDA 3500A?

Required information includes details of the patient (age, sex, weight), the adverse event description, product information (name, manufacturer, lot number), concomitant medications, outcomes of the event, and any previous exposure to the product.