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People also ask
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What is a FDA Form 3500A?
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. -
What does 21 CFR 314.80 deal with?
314.80 Postmarketing reporting of adverse drug experiences. -
What are the FDA requirements for reporting adverse events?
The event is serious and should be reported to FDA when the patient outcome is: Death. ... Life-threatening. ... Hospitalization (initial or prolonged) ... Disability or Permanent Damage. ... Congenital Anomaly/Birth Defect. ... Required Intervention to Prevent Permanent Impairment or Damage (Devices) ... Other Serious (Important Medical Events) -
What is the FDA adverse event reporting form?
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. -
How do I report an allergic reaction to the FDA?
Reporting Side Effects In addition to formal reports, MedWatch has a toll free line (1-800-332-1088) to answer questions. -
How are reporting forms 3500 3500B and 3500A different?
FDA Form 3500 and FDA Form 3500B are for voluntary reporting; FDA Form 3500A is for mandatory reporting. * The majority of the indirect, mandatory reports were not received by Agency on a paper version of form 3500A [by mail or fax] but via an electronic submission route.
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