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Adverse event reporting program

FORM FDA 3500-2025

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4.9 out of 5

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The document is the FDA Form 3500, used for voluntary reporting of adverse events, product problems, and medication errors related to drugs, medical devices, and other health products. It collects patient information, details about the adverse event or product issue, and information on suspect products or devices. The form emphasizes confidentiality and provides guidance on how to report serious adverse events.

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Click ‘Get Form’ to open FORM FDA 3500 in the editor.
Begin with Section A: Patient Information. Fill in the patient identifier, sex, age or date of birth, weight, gender, ethnicity, and race. Ensure all fields are completed accurately for effective reporting.
Move to Section B: Adverse Event/Product Problem. Select the type of report and outcomes attributed to the adverse event. Provide dates and a detailed description of the event or problem.
In Section C: Product Availability, indicate whether the product is available for evaluation and if you have a picture of it.
Proceed to Sections D and E for suspect products and medical devices. Enter relevant details such as product name, manufacturer, treatment dates, and any other pertinent information.
Complete Section G: Reporter by entering your name, address, contact information, and occupation. If confidentiality is a concern, mark the appropriate box.

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Versions	Form popularity	Fillable & printable
2022	4.9 Satisfied (47 Votes)
2019	4.1 Satisfied (60 Votes)
1996	4.9 Satisfied (36 Votes)

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How do I submit a FDA form 3500A?

Please submit the completed MedWatch 3500A form along with information to support the report, such as scans of labels and images of the serious adverse event, to FDA via: Email (preferred method for faster processing and reviewing): CosmeticAERS@fda.hhs.gov.

What is Form 3500 used for?

The purpose of form FTB 3500 is to apply for tax-exempt status from California franchise and income tax. If the organization provides all answers and documents required, the FTB will determine if the organization qualifies for tax‑exempt status.

What is an FDA 3500 form?

Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.

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).

How many days must a FDA mandatory reporting form 3500A be submitted to the FDA?

Initial reporting: Any unanticipated adverse event suspected to be caused/associated with a device must be reported to the FDA and the reviewing IRB within 10 working days of the event.

fda 3500 medwatch form

FDA Form 3500A pdf FDA Form 3500 vs 3500A FDA Form 3500B FDA Form 3500 instructions MedWatch form 3500A download FDA 3500A form submission requirements FDA MedWatch form When should a MedWatch form be submitted to the FDA

What is the difference between MedWatch Form 3500 and 3500A?

Form 3500 should be used by health care professionals, and Form 3500B should be used by patients and consumers. Reporting by health care professionals, patients, and consumers is voluntary. Form 3500A is designed for industry, which has mandatory adverse event reporting requirements.

What is 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.