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FDA Issues a Letter to Industry about Nitrosamine Impurities to Medical Device Combination Product Manufacturers
Today, FDA through the Center for Devices and Radiological Health (CDRH), issued a letter to provide manufacturers of CDRH-led combination products with information related to potential nitrosamine impurities. This letter describes manufacturer responsibilities and highlights resources that may assist in identifying and managing potential nitrosamine impurities in these products.
The letter encourages manufacturers to help ensure the continued safety and effectiveness of CDRH-led combination products and to engage with the FDA through the Q-Submission process to address potential risks related to nitrosamine impurities.
Questions?
If you have questions about this guidance, please contact the Division of Industry and Consumer Education.
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