Fda medwatch adverse event reporting program

Q: What are the adverse event reporting requirements for manufacturers of medical devices under an EUA? Manufacturers should refer to their EUA letter for a given authorized device for the particular reporting requirements. Medical device reporting under 21 CFR Part generally requires reporting of deaths, serious injuries, and malfunctions that have, may have, or would be likely to cause or contribute to a death or serious injury.

For more information regarding adverse event reporting for authorized medical devices, please refer to Section III. Also see the question below, Q: What product codes should be used when preparing adverse event reports for these products? Q: How does a device establishment create an eMDR account if it is not required to register and list?

Layout options: Carousel Grid List Card. Include data citation:. Copy to clipboard Close. Cite Data - Experimental. Structured data from the Bibframe namespace is licensed under the Creative Commons Attribution 4. Additional terms may apply to data associated with third party namespaces. First, there is no certainty that the reported event adverse event or medication error was due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.

Furthermore, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether an event will be reported, such as the time a product has been marketed and publicity about an event. There are also duplicate reports where the same report was submitted by a consumer and by the sponsor.

This tool makes the data easier to query and produces user-friendly information and charts. For example, users can view a summary of adverse event reports received from to the present or for a specific timeframe. In addition, users can search on a product of interest within a specific timeframe.

Yes, a recorded webinar is available which reviews the capabilities, and limitations, of the FAERS public dashboard. Yes, but the user interface layout may not be very user friendly.

In announcing these new materials, FDA issued a consumer alert explaining how and when to use the new consumer reporting form. Consumer reports are important, FDA recognized. They helped lead to a nationwide recall of a particular lot of pre-filled syringes.

Consumer reports also alerted FDA to an unusual issue: Men using a testosterone gel on their upper arms and shoulders were inadvertently exposing, and harming, children. MedWatch reports sometimes provide the first clue that an issue needs investigation and possible action.

In other cases, a clinician or researcher inside or outside FDA might first suspect a link between a problem and a drug or other product, and MedWatch becomes a useful database that FDA experts can search for additional clues. Consumers can continue to ask their health care professional to file a MedWatch report or to report a suspected problem directly to a drug manufacturer. By law, companies are required to report to FDA certain serious problems that may have been caused by their products, including in cases where consumers report suspected problems to the company.