D.C. Mun. Regs. tit. 22, r. 22-B10512

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

Rule 22-B10512 - WHEN A PREMARKET NOTIFICATION SUBMISSION IS REQUIRED

10512.1

Except as provided otherwise, each person who is required to register his or her establishment pursuant to § 10500 must submit a premarket notification submission to the Department at least ninety (90) days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria:

(a) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substantially equivalent to:

(1) A device in commercial distribution before May 28, 1976, or;

(2) A device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II.

(b) The device is being introduced into commercial distribution for the first time by a person required to register, whether or not the device meets the criteria in Paragraph (a) of this subsection; or

(c) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitutes significant changes or modifications that require a premarket notification:

(1) A change or modification in the device that could significantly affect the safety or effectiveness of the device (such as, a significant change or modification in design, material, chemical composition, energy source, or manufacturing process); or

(2) A major change or modification in the intended use of the device.

10512.2

A premarket notification under 21 C.F.R. § 807.81 is not required for a device for which a premarket approval application under Section 515 of the Act, or for which a petition to reclassify under Section 513 of the Act, is pending before the Department of Health.

10512.3

The appropriate Department employee may determine that the submission and grant of a written request for an exception or alternative satisfies the requirement in § 10512.1(c).

10512.4

In addition to complying with the requirements of this part, owners or operators of device establishments that manufacture radiation-emitting electronic products, as defined in the Act, shall comply with the reporting requirements of this chapter.

D.C. Mun. Regs. tit. 22, r. 22-B10512

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.