The Office of Combination Products (OCP) strives to ensure efficient, effective and clear premarket and postmarket policies and practices related to combination products and to the classification and assignment of human medical products. OCP welcomes comments from interested stakeholders on any policy issues that you believe should be addressed or clarified in guidance, regulations or otherwise. OCP also encourages medical product developers to contact us if they are uncertain about the classification or assignment of their products and with questions regarding premarket or postmarket considerations for combination products.
Please direct any comments or questions to firstname.lastname@example.org.
Food and Drug Administration
10903 New Hampshire Ave WO32-5129
Silver Spring, MD 20993