D.C. Mun. Regs. tit. 22, r. 22-B10727

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

Rule 22-B10727 - COMPLAINT FILES

10727.1

Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that:

(a) All complaints are processed in a uniform and timely manner;

(b) Oral complaints are documented upon receipt; and

(c) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to the Department under Chapter 104, Medical Device Reporting.

10727.2

Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.

10727.3

Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

10727.4

Any complaint that represents an event which must be reported to the Department under Chapter 104 shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by § 10726.5, records of investigation within this section shall include a determination of:

(a) Whether the device failed to meet specifications;

(b) Whether the device was being used for treatment or diagnosis; and

(c) The relationship, if any, of the device to the reported incident or adverse event.

10727.5

When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in § 10726.1. The record of investigation shall include:

(a) The name of the device;

(b) The date the complaint was received;

(c) Any device identification(s) and control number(s) used;

(d) The name, address, and phone number of the complainant;

(e) The nature and details of the complaint;

(f) The dates and results of the investigation;

(g) Any corrective action taken; and

(h) Any reply to the complainant.

10727.6

When the manufacturer's formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.

10727.7

If a manufacturer's formally designated complaint unit is located outside of the U. S., records required by this section shall be reasonably accessible in the U.S. at either:

(a) A location in the U.S. where the manufacturer's records are regularly kept; or

(b) The location of the initial distributor.

D.C. Mun. Regs. tit. 22, r. 22-B10727

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.