D.C. Mun. Regs. tit. 22, r. 22-B10507

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

Rule 22-B10507 - NOTIFICATION OF REGISTRANT

10507.1

The Department will provide to the official correspondent, at the address listed on the form, a validated copy of Form FDA-2891 or Form FDA-2891a (whichever is applicable) or their Department equivalent as evidence of registration. A permanent registration number will be assigned to each device establishment registered in accordance with these regulations.

10507.2

Owners and operators of device establishments who also manufacture or process blood or drug products at the same establishment shall also register with the Department.

10507.3

Although establishment registration and device listing are required to engage in the device activities described in § 10500, validation of registration and the assignment of a device listing number in itself does not establish that the holder of the registration is legally qualified to deal in such devices and does not represent a determination by the Department of Health as to the status of any device.

D.C. Mun. Regs. tit. 22, r. 22-B10507

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.