D.C. Mun. Regs. tit. 22, r. 22-B10900

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10900 - 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.

D.C. Mun. Regs. tit. 22, r. 22-B10900

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.