FDA’s industry/small business assistance offices

CDRH DICE – Division of Industry and Consumer Education
Phone: 1(800) 638-2041 or (301) 796-7100; Email: DICE@fda.hhs.gov

The Division of Industry and Consumer Education (DICE) answers questions (by phone and email) from the medical device industry and consumers of medical devices and radiation-emitting electronic products. In addition, DICE develops educational resources for the FDA website to help the medical device industry understand FDA regulations and policies.

CDER SBIA – Small Business & Industry Assistance
Phone: (866) 405-5367 or (301) 796-6707; Email: CDERSBIA@fda.hhs.gov

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

CBER MATTB – Manufacturers Assistance and Technical Training Branch
Phone: 240-402-8020 or 1-800-835-4709; Email: Industry.Biologics@fda.hhs.gov

CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.