Mandatory Medical Device Problem Reporting for Industry 2011-2025 Form
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People also ask
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What is required in an FDA annual report?
Specifically, this annual summary must include the name of the investigational drug, the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. FDA is required to specify the deadline for such reporting submissions.
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What needs to be reported to the FDA?
When do you need to submit 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.
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What are the requirements for MDR?
The Medical Device Reporting (MDR) Regulation requires medical device manufacturers, device user facilities and importers to establish a system that ensures the prompt identification, timely investigation, reporting, documentation, and filing of device-related death, serious injury, and malfunction information.
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What are the requirements for MDR reporting?
If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified followup.
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What is MDR in FDA?
Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
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What are the regulations that the FDA enforces?
FDA enforces the Federal Food, Drug and Cosmetic Act (FD&C Act) and other related acts. This page provides an overview of FDA's import compliance and enforcement activities at the point of entry. FDA has jurisdiction over imported products at the time of entry but also after the products have entered domestic commerce.
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How do I submit an MDR?
Manufacturers and importers should submit reports in electronic format for processing, reviewing, and archiving using form 3500A. User facilities may submit their reports electronically or on paper using form 3500A. For additional guidance on MDR submission, check the mandatory reporting instructions section here.
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What are the mandatory reporting requirements for the FDA?
Manufacturers must report deaths, serious injuries, and certain malfunctions to FDA within 30 calendar days of becoming aware. Certain events requiring remedial action, however, must be reported within 5 work days.
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