![]() CDRH prioritizes the review of allegations based on the level of potential risks, within the context of an overall benefit-risk profile, to patients. If you have questions about submitting an allegation, you may contact the Allegations of Regulatory Misconduct Staff by phone at (240)402-7675 or by email at What happens to allegations of regulatory misconduct submitted to the FDA?Īllegations of regulatory misconduct related to medical devices are reviewed by the Center for Devices and Radiological Health (CDRH). For questions about other medical device topics, please contact the CDRH Division of Industry and Consumer Education. To report serious adverse reactions, product quality problems, therapeutic inequivalence/failure, and product use errors associated with FDA-regulated drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics, visit the MedWatch adverse event reporting webpage. Detailed description of the allegation with any available supporting documentation.Unique Device Identifier (UDI), if known.Lot numbers/serial numbers/part numbers.Name of the device and model (if applicable).Address and telephone number of the company, if known.Medical device(s) in question, including:. ![]() ![]() The following information helps the FDA assess an allegation: Silver Spring, MD 20993 What information should I include when reporting an allegation of regulatory misconduct? You can submit an allegation through the Allegations of Regulatory Misconduct Form, by email, or by regular Mail:Īttention: Allegations of Regulatory Misconduct TeamĬenter for Devices and Radiological Health How do I submit an allegation about a medical device manufacturer to the FDA? For example, the manufacturer hides information from the FDA, or falsifies documents, etc.
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