D.C. Mun. Regs. tit. 22, r. 22-B10600

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

Rule 22-B10600 - SCOPE

10600.1

This section provides procedures for the premarket approval of medical devices intended for human use.

10600.2

This section applies to any class III medical device, unless exempt under 21 U.S.C. § 360j, that:

(a) Was not on the market (introduced or delivered for introduction into commerce for commercial distribution) before May 28, 1976, and is not substantially equivalent to a device on the market before May 28, 1976, or to a device first marketed on, or after that date, which has been classified into class I or class II;

(b) Is required to have an approved premarket approval application (PMA) or a declared completed product development protocol under a regulation issued under 21 U.S.C. § 360e(b); or

(c) Was regulated by the Department as a new drug or antibiotic drug before May 28, 1976, and therefore is governed by 21 U.S.C. § 360j(1).

10600.3

This part amends the conditions to approval for any premarket approval (PMA) approved before the effective date of this part. Any condition to approval for an approved PMA that is inconsistent with this part is revoked. Any condition to approval for an approved PMA that is consistent with this part remains in effect.

D.C. Mun. Regs. tit. 22, r. 22-B10600

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.