Regulation Text
The Office of Combination Products (Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930,, e-mail: combination@fda.gov , is the designated product jurisdiction officer.
Authority
21 U.S.C. 321,351,353,355,360,360c-360f,360h-360j,360gg-360ss,360bbb-2,371(a),379e,381,394;42 U.S.C. 216,262,264.