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3500a 2022-2024 Form
Video instructions and help with filling out and completing Form FDA 3500A MedWatch
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Under what circumstances must a MedWatch form be completed?
Circumstances Making the Collection of Information Necessary Abstract: Members of the public use FDA's MedWatch system to report adverse outcomes, product quality problems, product use errors and therapeutic failure/inequivalence to FDA for all human healthcare products except vaccines. -
Is MedWatch mandatory?
MedWatch Form FDA 3500A (Mandatory Reporting) Form FDA 3500A is used by manufacturers, user facilities, distributers, importers, and other respondents subject to mandatory reporting. Mandatory reporting of adverse events or product experiences is governed by statute and often codified in Agency regulations. -
What are the four sections of the MedWatch form that must be completed in order for FDA to properly file it into their databases?
There are four sections of the MedWatch report that must be completed in order for FDA to properly file it into their databases: patient identifier, event or problem that occurred, reporter information, and product information. -
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. -
When should a MedWatch form be submitted?
Medical device companies must submit the appropriate MedWatch forms in a timely manner when they become aware that an adverse event has occurred, with failure to comply potentially leading to fines or other legal action. -
Is MedWatch reporting mandatory?
MedWatch Form FDA 3500A (Mandatory Reporting) Form FDA 3500A is used by manufacturers, user facilities, distributers, importers, and other respondents subject to mandatory reporting. Mandatory reporting of adverse events or product experiences is governed by statute and often codified in Agency regulations. -
What are the requirements for MDR reporting?
Mandatory Medical Device Reporting Requirements Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. -
What is the difference between MedWatch Form 3500 and 3500B?
Form FDA 3500 is used for voluntary (i.e., not mandated by law or regulation) reporting by healthcare professionals. Form FDA 3500B is a consumer-friendly version of Form FDA 3500 that is intended for use by the general public who are not healthcare professionals (i.e. patients, caregivers).
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