Form fda 3500a * 2014-2025

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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.
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.
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.
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).
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.
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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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