Form FDA-3500A MedWatch 2025

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The document is the FDA Form 3500A, a mandatory reporting form for user-facilities, importers, distributors, and manufacturers to report adverse events or product problems related to medical products. It collects detailed patient information, event descriptions, suspect products, and initial reporter details to ensure compliance with health regulations.

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Versions	Form popularity	Fillable & printable
2022	4.2 Satisfied (31 Votes)
2019	4.9 Satisfied (52 Votes)
2015	4.8 Satisfied (50 Votes)
2009	4.3 Satisfied (55 Votes)
2003	4.9 Satisfied (49 Votes)

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What is form 3500A?

Use form FTB 3500A to obtain California tax-exempt status, if the organization has a federal determination letter granting exemption under IRC Sections 501(c)(3), 501(c)(4), 501(c)(5), 501(c)(6), 501(c)(7), or 501(c)(19).

When should a MedWatch form be submitted to the FDA?

Initial reporting: Any suspected adverse events or any adverse events that are considered serious and unexpected must be reported to the FDA as soon as possible but no later than within 15 calendar days of first being notified of the event.

What is a 3500A form?

Purpose. Use form FTB 3500A to obtain California tax-exempt status, if the organization has a federal determination letter granting exemption under IRC Sections 501(c)(3), 501(c)(4), 501(c)(5), 501(c)(6), 501(c)(7), or 501(c)(19).

What is the difference between 3500 and 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 is the FDA Form 3500 used for?

Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.