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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR803]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 803MEDICAL DEVICE REPORTING
 

Subpart C--User Facility Reporting Requirements

Sec. 803.30 If I am a user facility, what reporting requirements apply to me?

(a) You must submit reports to the manufacturer or to us, or both, as specified below:

(1)Reports of death . You must submit a report to us as soon as practicable but no more than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known. You must report information required by 803.32 on FDA Form 3500A or an electronic equivalent approved under 803.14.

(2)Reports of serious injury . You must submit a report to the manufacturer of the device no later than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to us. You must report information required by 803.32 on FDA Form 3500A or an electronic equivalent approved under 803.14.

(b) What information does FDA consider "reasonably known" to me? You must submit all information required in this subpart C that is reasonably known to you. This information includes information found in documents that you possess and any information that becomes available as a result of reasonable followup within your facility. You are not required to evaluate or investigate the event by obtaining or evaluating information that you do not reasonably know.

Sec. 803.32 If I am a user facility, what information must I submit in my individual adverse event reports?

You must include the following information in your report, if reasonably known to you, as described in 803.30(b). These types of information correspond generally to the elements of FDA Form 3500A:

(a) Patient information (Form 3500A, Block A). You must submit the following:

(1) Patient name or other identifier;

(2) Patient age at the time of event, or date of birth;

(3) Patient gender; and

(4) Patient weight.

(b) Adverse event or product problem (Form 3500A, Block B). You must submit the following:

(1) Identification of adverse event or product problem;

(2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is considered a serious injury if it is:

(i) Life-threatening injury or illness;

(ii) Disability resulting in permanent impairment of a body function or permanent damage to a body structure; or

(iii) Injury or illness that requires intervention to prevent permanent impairment of a body structure or function;

(3) Date of event;

(4) Date of report by the initial reporter;

(5) Description of event or problem, including a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event;

(6) Description of relevant tests, including dates and laboratory data; and

(7) Description of other relevant history, including preexisting medical conditions.

(c) Device information (Form 3500A, Block D). You must submit the following:

(1) Brand name;

(2) Type of device;

(3) Manufacturer name and address;

(4) Operator of the device (health professional, patient, lay user, other);

(5) Expiration date;

(6) Model number, catalog number, serial number, lot number, or other identifying number;

(7) Date of device implantation (month, day, year);

(8) Date of device explantation (month, day, year);

(9) Whether the device was available for evaluation and whether the device was returned to the manufacturer; if so, the date it was returned to the manufacturer; and

(10) Concomitant medical products and therapy dates. (Do not report products that were used to treat the event.)

(d) Initial reporter information (Form 3500A, Block E). You must submit the following:

(1) Name, address, and telephone number of the reporter who initially provided information to you, or to the manufacturer or distributor;

(2) Whether the initial reporter is a health professional;

(3) Occupation; and

(4) Whether the initial reporter also sent a copy of the report to us, if known.

(e) User facility information (Form 3500A, Block F). You must submit the following:

(1) An indication that this is a user facility report (by marking the user facility box on the form);

(2) Your user facility number;

(3) Your address;

(4) Your contact person;

(5) Your contact person's telephone number;

(6) Date that you became aware of the event (month, day, year);

(7) Type of report (initial or followup); if it is a followup, you must include the report number of the initial report;

(8) Date of your report (month, day, year);

(9) Approximate age of device;

(10) Event problem codes--patient code and device code (refer to the "MEDWATCH Medical Device Reporting Code Instructions");

(11) Whether a report was sent to us and the date it was sent (month, day, year);

(12) Location where the event occurred;

(13) Whether the report was sent to the manufacturer and the date it was sent (month, day, year); and

(14) Manufacturer name and address, if available.

Sec. 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) 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.

(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.

Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Source: 70 FR 9519, July 13, 2005, unless otherwise noted

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