42 U.S.C. § 3512
Office to assist small manufacturers of medical devices; establishment
The Secretary of Health and Human Services shall establish within the Department of Health and Human Services an identifiable office to provide technical and other nonfinancial assistance to small manufacturers of medical devices to assist them in complying with the requirements of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], as amended by this Act.