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The MedWatch system is intended to detect safety hazard signals for medical products. If a signal is detected, the FDA can issue medical product safety alerts or order product recalls, withdrawals, or labeling changes to protect the public health.
Based on an evaluation of the potential safety concern, The FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
Medical device safety alert: This alert is "issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered ...
A popular arthritis medication for dogs has sickened thousands of pets and likely caused others to die, the Food and Drug Administration said in an urgent warning. Dangerous side effects from the ...
If you come across or suspect counterfeit Botox being used you can report it on the FDA’s website or by calling 800-551-3989.
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