Medwatch Form 3500a Download
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People also ask
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How do I submit a MedWatch form?
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. -
What is a MedWatch form?
“A MedWatch Form is used to report an adverse or sentinel event to MedWatch” - the United States Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program. Founded in 1993, the MedWatch program was established by the FDA to help collect data on adverse events in the healthcare industry. -
What is a MedWatch Form 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 type of information is required on Form FDA 3500A?
List and provide product names and therapy dates for any other medical products (drugs, biologics, including human cells, tissues, and cellular and tissue-based products (HCT/Ps), or medical devices, etc.) that the patient was using at the time of the event. -
How are reporting forms 3500 3500B and 3500A different?
Form FDA 3500B is written in plain language and is intended to be used for voluntary reporting (i.e., not mandated by law or regulation) by consumers (i.e., patients and their caregivers). Form FDA 3500A is used for mandatory reporting (i.e., required by law or regulation). -
When should a MedWatch form be submitted to the FDA?
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. -
Where can MedWatch forms be found?
You may continue to use this Form FDA 3500, but can find a link to the new consumer form on the MedWatch homepage: .fda.gov/medwatch. -
What are the different types of MedWatch forms?
MedWatch Forms for FDA Safety Reporting MedWatch for Health Professionals FDA Form 3500 pdf. ... MedWatch Forms for Patients and Consumers FDA Form 3500B pdf. ... MedWatch for Industry FDA Form 3500A pdf. ... MedWatch Online Reporting for Health Professionals, Patients and Consumers.
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