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Reset Form DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0291 Expires: 6-30-2025 See PRA statement on page 6. FDA USE ONLY FORM 3500A Mfr report.
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Medwatch form fda 3500 FAQ
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).
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).
Mail form FTB 3500A and a copy of the federal determination letter to: EXEMPT ORGANIZATIONS UNIT, MS F120, FRANCHISE TAX BOARD, PO BOX 1286, RANCHO CORDOVA CA 95741-1286.
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.
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.
A user facility is required to report a device-related death or a device-related serious injury to the manufacturer and to report a device-related death to FDA. Manufacturers must prepare and submit a complete Form FDA 3500A for each suspect device.
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.
Fda 3500a Related content
FORM FDA 3500A SUPPLEMENT
GENERAL INSTRUCTIONS – for Form FDA 3500A MedWatch (for Mandatory reporting). • All...
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