[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR803.52]



[Page 52-54]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                          SERVICES (CONTINUED)

 

PART 803_MEDICAL DEVICE REPORTING--Table of Contents

 

              Subpart E_Manufacturer Reporting Requirements

 

Sec.  803.52  If I am a manufacturer, what information must I submit in 

my individual adverse event reports?



    You must include the following information in your reports, if known 

or reasonably known to you, as described in Sec.  803.50(b). These types 

of information correspond generally to the format of FDA Form 3500A:

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

following:

    (1) Patient name or other identifier;



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    (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 the 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) Other relevant patient 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) Your 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 you, and if so, the date it was returned to you; 

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 phone number of the reporter who initially 

provided information to you, or to the user facility or importer;

    (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) Reporting information for all manufacturers (Form 3500A, Block 

G). You must submit the following:

    (1) Your reporting office's contact name and address and device 

manufacturing site;

    (2) Your telephone number;

    (3) Your report sources;

    (4) Date received by you (month, day, year);

    (5) Type of report being submitted (e.g., 5-day, initial, followup); 

and

    (6) Your report number.

    (f) Device manufacturer information (Form 3500A, Block H). You must 

submit the following:

    (1) Type of reportable event (death, serious injury, malfunction, 

etc.);

    (2) Type of followup report, if applicable (e.g., correction, 

response to FDA request, etc);

    (3) If the device was returned to you and evaluated by you, you must 

include a summary of the evaluation. If you did not perform an 

evaluation, you must explain why you did not perform an evaluation;

    (4) Device manufacture date (month, day, year);

    (5) Whether the device was labeled for single use;

    (6) Evaluation codes (including event codes, method of evaluation, 

result, and conclusion codes) (refer to FDA MEDWATCH Medical Device 

Reporting Code Instructions);

    (7) Whether remedial action was taken and the type of action;

    (8) Whether the use of the device was initial, reuse, or unknown;

    (9) Whether remedial action was reported as a removal or correction 

under section 519(f) of the act, and if it was, provide the correction/

removal report number; and

    (10) Your additional narrative; and/or



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    (11) Corrected data, including:

    (i) Any information missing on the user facility report or importer 

report, including any event codes that were not reported, or information 

corrected on these forms after your verification;

    (ii) For each event code provided by the user facility under Sec.  

803.32(e)(10) or the importer under 803.42(e)(10), you must include a 

statement of whether the type of the event represented by the code is 

addressed in the device labeling; and

    (iii) If your report omits any required information, you must 

explain why this information was not provided and the steps taken to 

obtain this information.