10900. SCOPE

10900 SCOPE 10900.1 The purpose of this chapter is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose. This chapter provides procedures for the conducting clinical investigations of devices. An approved IDE permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device. An IDE approved under § 10910 or considered approved under § 10901 exempts a device from the requirements of the following sections of the Act and regulations issued thereunder: (a) Misbranding under 21 U.S.C. § 352; (b) Registration, listing, and premarket notification under 21 U.S.C. § 360; (c) Performance standards under 21 U.S.C. § 360d; (d) Premarket approval under 21 U.S.C. § 360e; (e) A banned device regulation under 21 U.S.C. § 360f; (f) Records and reports under 21 U.S.C. § 360i; (g) Restricted device requirements under 21 U.S.C. § 360j(e); (h) Good manufacturing practice requirements under 21 U.S.C. § 360j(f) except for the requirements found in § 10705 of this subtitle, if applicable (unless the sponsor states an intention to comply with these requirements under §§ 10907.2 (c) or 10927.2(d)(5) of this subtitle); and (i) Color additive requirements. SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10900