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 documents should I provide to FDA? You should provide FDA with entry documentation which may include the following: Bill of Lading (BOL), Airway Bill (AWB), invoice, and purchase order.

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.

Form FDA 3881, or the Indications for Use Statement, should have the same information as the indications for use listed throughout the rest of the 510(k), including device labeling. It should identify whether the device is for prescription and/or over-the-counter use.

Indications for use for a device include a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.

Forms may be downloaded from our website at https://.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting and submitted by Fax or mail following the instructions; by completing and submitting forms online; or by calling FDA at 800-FDA-1088 (800-322-1088) and reporting by telephone.

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.