FDA Medwatch (3500&3500A) Flashcards
What is FDA Form 3500?
FDA Form 3500 is the MedWatch form used for the voluntary reporting of adverse events, product complaints, and other serious problems with medical products.
What agency is responsible for receiving and reviewing FDA Form 3500?
The FDA (Food and Drug Administration)
When should FDA Form 3500 be used in the context of clinical trials?
FDA Form 3500 should be used to report adverse events, product complaints, and other issues related to investigational products in clinical trials.
Who can submit FDA Form 3500?
Anyone, including healthcare professionals, consumers, and manufacturers, can submit FDA Form 3500 to report adverse events or product complaints.
What is the purpose of reporting adverse events on FDA Form 3500?
The purpose is to provide the FDA with information about adverse events associated with the use of medical products, including investigational drugs in clinical trials.
Describe the sections of FDA Form 3500.
The form typically includes sections for patient information, adverse event details, product information, reporter information, and additional narrative information.
Explain the difference between a serious and non-serious adverse event on FDA Form 3500.
A serious adverse event involves death, a life-threatening situation, hospitalization, disability, or other significant medical events.
How soon should serious and unexpected adverse events be reported on FDA Form 3500 to the FDA and the IRB?
Serious and unexpected adverse events should be reported to the FDA and the IRB as soon as possible but within 7 or 15 calendar days, depending on the scenario.
Describe the requirements for submitting a “Voluntary” MedWatch report on FDA Form 3500.
Anyone can voluntarily submit a MedWatch report using FDA Form 3500 to provide information on adverse events, product complaints, and safety concerns.
What is FDA Form 3500A used for?
Used for mandatory reporting of adverse events and product complaints to the FDA by manufacturers, distributors, importers, and users of medical products.
What types of products are covered by FDA Form 3500A?
medical products, including drugs, biologics, devices, dietary supplements, and cosmetics.
