FDA MedWatch: What It Is, Who Reports, Which Form to Use

Not medical advice. This page describes a federal reporting program; it does not tell any patient or clinician what to do about a specific product or event.

Short answer

MedWatch is the FDA’s medical product safety reporting program for health professionals, patients and consumers. Patients, consumers and clinicians report voluntarily, using Form 3500B, Form 3500 or MedWatch Online. Manufacturers, importers and device user facilities have mandatory duties, and Form 3500A is for those reporters only when electronic submission is not required. Vaccines, tobacco and animal products use other portals.

What FDA MedWatch is

MedWatch is a program, not a single form. According to FDA, it receives reports from the public about serious reactions, product quality problems, therapeutic inequivalence or failure, and product use errors, and it publishes safety alerts when appropriate. FDA states that it “relies on the voluntary reporting of these events.”

FDA’s program page gives these examples of what falls inside it:

• prescription and over-the-counter medicines, including those given in hospitals or infusion centers;
• biologics, such as blood components and gene therapies;
• medical devices, such as glucose-test kits and hearing aids;
• combination products, such as prefilled syringes and auto-injectors;
• cannabinoid hemp products and cosmetics.

Reporting can also be done by phone: FDA’s line is 1-888-INFO-FDA (1-888-463-6332), and callers press 2 to report into MedWatch or ask for instructions.

Voluntary vs mandatory MedWatch reporting

The split is by who you are, not by which product you are reporting about.

Reporter	Status	Route FDA names
Consumer or patient	Voluntary	Form 3500B (a consumer/patient-friendly version of Form 3500; a Spanish version exists) or MedWatch Online
Health professional	Voluntary	Form 3500 (designed for healthcare professionals) or MedWatch Online
Manufacturer, distributor, importer, device user facility, IND reporter	Mandatory	Form 3500A, used only when electronic submission is not required; industry reports must otherwise be submitted electronically

Mandatory device deadlines in 21 CFR Part 803

For medical devices, the mandatory side has fixed clocks in 21 CFR 803.10, checked on eCFR on 2026-11-01. Voluntary reports carry no equivalent deadline.

Reporter	Event	Goes to	Deadline
User facility	Death	FDA and the manufacturer (if known)	10 work days after becoming aware
User facility	Serious injury	The manufacturer (FDA if the manufacturer is unknown)	10 work days
Importer	Death or serious injury	FDA and the manufacturer	30 calendar days
Importer	Malfunction	The manufacturer	30 calendar days
Manufacturer	Reportable death, serious injury or malfunction	FDA	30 calendar days
Manufacturer	Event needing remedial action for an unreasonable risk of substantial harm to public health, or one FDA requests in writing	FDA	5 work days

User facilities also send annual reports to FDA. For the form fields behind the mandatory route, see MedWatch Form 3500A section by section; for the facility checklist, see Safe Medical Devices Act reporting duties; the regulation itself is summarised in Medical Device Reporting (MDR).

Which route for which product

MedWatch is not the only FDA door. FDA’s pages direct these reports elsewhere:

• Vaccines: Vaccine Online Reporting (VAERS). See VAERS reporting.
• Tobacco products and e-cigarettes: the Safety Reporting Portal.
• Animal products: FDA’s separate veterinary reporting page.
• Drugs and biologics, medical devices, dietary supplements, infant formula, cosmetics: MedWatch.

Where it matters for labs and clinics

Staff at a clinic or hospital that qualifies as a device user facility fall under the mandatory device route in 21 CFR 803.10, with the 10-work-day clocks above. A clinician who is not acting under such a duty reports voluntarily on Form 3500 or through MedWatch Online. Reports about drugs and biologics land in the database described at FDA Adverse Event Reporting System (FAERS), while device events can later be read in the public record explained at how to read a MAUDE report.

Common misunderstandings

• “MedWatch is Form 3500.” The program has three forms and an online portal. Which one applies depends on the reporter.
• “Only injuries count.” FDA’s program covers product quality problems, therapeutic inequivalence or failure, and product use errors as well as serious reactions.
• “Form 3500A is the more official form.” It is the mandatory-reporter form, used only when electronic submission is not required; it is not an upgrade for voluntary reports.
• “A vaccine problem goes to MedWatch.” FDA directs vaccine reports to VAERS.

FAQ

What is MedWatch?

MedWatch is the FDA’s medical product safety reporting program for health professionals, patients and consumers, and the channel through which FDA publishes safety alerts when appropriate.

What is a MedWatch report?

It is a submission to FDA about a serious reaction, a product quality problem, therapeutic inequivalence or failure, or a product use error involving a human medical product. Voluntary reports use Form 3500, Form 3500B or MedWatch Online; mandatory reports from industry use Form 3500A when electronic submission is not required.

How does MedWatch reporting work?

Consumers, patients and health professionals report voluntarily. Manufacturers, importers and device user facilities report under mandatory rules; for devices, the clocks are in the table above. FDA also takes reports by phone at 1-888-INFO-FDA, option 2.

Can I use MedWatch online?

Yes. FDA states that MedWatch Online can be used by health professionals, consumers and patients to submit voluntary reports.

Sources

• FDA, MedWatch: The FDA Safety Information and Adverse Event Reporting Program, checked 2026-11-01.
• FDA, Reporting Serious Problems to FDA, checked 2026-11-01.
• FDA, MedWatch Forms for FDA Safety Reporting, checked 2026-11-01.
• eCFR, 21 CFR Part 803, Medical Device Reporting (section 803.10), checked 2026-11-01.