D.C. Mun. Regs. tit. 22, r. 22-B10417

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

Rule 22-B10417 - ANNUAL REPORTS

10417.1

You must submit to the Department an annual report on in writing or electronic equivalent. You must submit an annual report by January 1 of each year. You must clearly identify your annual report as such. Your annual report must include:

(a) Your Centers for Medicare & Medicaid (CMS) provider number used for medical device reports, or the number that the Department assigns for reporting purposes;

(b) Reporting year;

(c) Your name and complete address;

(d) The total number of reports attached or summarized;

(e) The date of the annual report and report numbers identifying the range of medical device reports that you submitted during the report period;

(f) The name, position title, and complete address of the individual designated as your contact person responsible for reporting to the Department and whether that person is a new contact for you; and

(g) Information for each reportable event that occurred during the annual reporting period including:

(1) The report number;

(2) The name and address of the device manufacturer;

(3) The device brand name and common name;

(4) The product model, catalog, serial and lot numbers;

(5) A brief description of the event reported to the manufacturer or the Department; and

(6) Where the report was submitted (for example, to the manufacturer, importer, or the Department).

10417.2

If you did not submit any medical device reports to manufacturers or us during the time period, you do not need to submit an annual report.

D.C. Mun. Regs. tit. 22, r. 22-B10417

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.