21 CFR 803.33 - If I am a user facility, what must I include when I submit an annual report?

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§ 803.33 If I am a user facility, what must I include when I submit an annual report?
(a) You must submit to us an annual report on FDA Form 3419, or electronic equivalent as approved by us under § 803.14. 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:
(1) Your CMS provider number used for medical device reports, or the number assigned by us for reporting purposes in accordance with § 803.3;
(2) Reporting year;
(3) Your name and complete address;
(4) Total number of reports attached or summarized;
(5) Date of the annual report and report numbers identifying the range of medical device reports that you submitted during the report period (e.g., 1234567890-2004-0001 through 1000);
(6) Name, position title, and complete address of the individual designated as your contact person responsible for reporting to us and whether that person is a new contact for you; and
(7) Information for each reportable event that occurred during the annual reporting period including:
(i) Report number;
(ii) Name and address of the device manufacturer;
(iii) Device brand name and common name;
(iv) The unique device identifier (UDI) that appears on the device label or on the device package;
(v) Product model, catalog, serial and lot number;
(vi) A brief description of the event reported to the manufacturer and/or us; and
(vii) Where the report was submitted, i.e., to the manufacturer, importer, or us.
(b) In lieu of submitting the information in paragraph (a)(7) of this section, you may submit a copy of FDA Form 3500A, or an electronic equivalent approved under § 803.14, for each medical device report that you submitted to the manufacturers and/or to us during the reporting period.
(c) 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.
[70 FR 9519, July 13, 2005, as amended at 78 FR 58820, Sept. 24, 2013]
Effective Date Note:
At 79 FR 8846, Feb. 14, 2014, part 803 was revised, and § 803.58 was suspended indefintely, effective Aug. 14, 2015. For the convenience of the user, the revised text appears as follows:
PART 803—MEDICAL DEVICE REPORTING (Eff. 8-14-15)
§ 803.33 If I am a user facility, what must I include when I submit an annual report?
(a) You must submit to us an annual report on Form FDA 3419. You must submit an annual report by January 1, of each year. You may obtain this form from the following sources:
(2) Division of Small Manufacturers, International and Consumer Assistance, Office of Communication and Education, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002, by email: DSMICA@fda.hhs.gov, FAX: 301-847-8149, or telephone: 800-638-2041.
(b) You must clearly identify your annual report as such. You must submit your annual report to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002. Your annual report must include:
(1) Your CMS provider number used for medical device reports, or the number assigned by us for reporting purposes in accordance with § 803.3;
(2) Reporting year;
(3) Your name and complete address;
(4) Total number of reports attached or summarized;
(5) Date of the annual report and report numbers identifying the range of medical device reports that you submitted during the report period (e.g., 1234567890-2011-0001 through 1000);
(6) Name, position title, and complete address of the individual designated as your contact person responsible for reporting to us and whether that person is a new contact for you; and
(7) Information for each reportable event that occurred during the annual reporting period including:
(i) Report number;
(ii) Name and address of the device manufacturer;
(iii) Device brand name and common name;
(iv) Product model, catalog, serial and lot number;
(v) A brief description of the event reported to the manufacturer and/or us; and
(vi) Where the report was submitted, i.e., to the manufacturer, importer, or us.
(c) In lieu of submitting the information in paragraph (b)(7) of this section, you may submit a copy of each medical device report that you submitted to the manufacturers and/or to us during the reporting period.
(d) 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.

Title 21 published on 2014-04-01

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