D.C. Mun. Regs. tit. 22, r. 22-B10505

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

Rule 22-B10505 - UPDATING DEVICE LISTING INFORMATION

10505.1

Form FDA-2892 or its Department equivalent shall be used to update device listing information. The preprinted original document number of each form FDA-2892 or its Department equivalent on which the device was initially listed shall appear on the form subsequently used to update the listing information for the device and on any correspondence related to the device.

10505.2

An owner or operator shall update the device listing information during each June and December or, at its discretion, at the time the change occurs. Conditions that require updating and information to be submitted for each of these updates are as follows:

(a) If an owner or operator introduces into commercial distribution a device identified with a classification name not currently listed by the owner or operator, then the owner or operator must submit form FDA-2892 or its Department equivalent containing all the information required by § 10503.6;

(b) If an owner or operator discontinues commercial distribution of all devices in the same device class (for example, with the same classification name), the owner or operator must submit a form containing the original document number on which the device class was initially listed, the reason for submission, the date of discontinuance, the owner or operator's name and identification number, the classification name and number, the proprietary name, and the common or usual name of the discontinued device.

(c) If commercial distribution of a discontinued device identified on a form filed under this section is resumed, the owner or operator must submit a notice of resumption containing:

(1) The original document number of the form initially used to list that device class;

(2) The reason for submission;

(3) The date of resumption; and

(4) All other information required.

(d) If one (1) or more classification names for a previously listed device with multiple classification names has been added or deleted, the owner or operator must supply the original document number on which the device was initially listed and a supplemental sheet identifying the names of any new or deleted classification names.

(e) Other changes to information will be updated as follows:

(1) Whenever a change occurs only in the owner or operator name or number (for example, whenever one company's device line is purchased by another owner or operator) it will not be necessary to supply a separate form for each device. In such cases, the new owner or operator must submit a letter informing the Department of the original document number on which device was initially listed for those devices affected by the change in ownership;

(2) The owner or operator must also submit update information whenever establishment registration numbers, establishment names, or activities are added to or deleted. The owner or operator must supply the original document number on which the device was initially listed, the reason for submission, and all other information required.

(f) Updating is not required if the above information has not changed since the previously submitted list. Also, updating is not required if changes occur in proprietary names, in common or usual names, or to supplemental lists of unclassified components or accessories.

D.C. Mun. Regs. tit. 22, r. 22-B10505

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.