10201. APPLICABLE LAWS AND REGULATIONS

10201 APPLICABLE LAWS AND REGULATIONS 10201.1 The Department of Health (Department or DOH) adopts by reference the following laws and regulations: (a) Federal Food, Drug, and Cosmetic Act, approve June 25, 1938, 21 U.S.C. § 301, et seq. (“act”) as amended; (b) 21 Code of Federal Regulations (C.F.R.), part 801, Labeling, as amended; (c) 21 C.F.R., part 803, Medical Device Reporting, as amended; (d) 21 C.F.R., part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices, as amended; (e) 21 C.F.R., part 814, Premarket Approval of Medical Devices, as amended; (f) 21 C.F.R., part 820, Quality System Regulation, as amended; and (g) 21 C.F.R., Subchapter J--Radiological Health, as amended. 10201.2 Copies of these laws and regulations are indexed and filed at the Department, 899 North Capitol Street, N.E., Washington, D.C. 20002 and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at www.hpla.doh.dc.gov. 10201.3 Nothing in these sections shall relieve any person of the responsibility for compliance with other applicable District of Columbia and federal laws and regulations. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10201