[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: 21CFR803.50]



[Page 52]

 

                        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.  803.50  If I am a manufacturer, what reporting requirements apply 

to me?





    (a) If you are a manufacturer, you must report to us no later than 

30 calendar days after the day that you receive or otherwise become 

aware of information, from any source, that reasonably suggests that a 

device that you market:

    (1) May have caused or contributed to a death or serious injury; or

    (2) Has malfunctioned and this device or a similar device that you 

market would be likely to cause or contribute to a death or serious 

injury, if the malfunction were to recur.

    (b) What information does FDA consider ``reasonably known'' to me?

    (1) You must submit all information required in this subpart E that 

is reasonably known to you. We consider the following information to be 

reasonably known to you:

    (i) Any information that you can obtain by contacting a user 

facility, importer, or other initial reporter;

    (ii) Any information in your possession; or

    (iii) Any information that you can obtain by analysis, testing, or 

other evaluation of the device.

    (2) You are responsible for obtaining and submitting to us 

information that is incomplete or missing from reports submitted by user 

facilities, importers, and other initial reporters.

    (3) You are also responsible for conducting an investigation of each 

event and evaluating the cause of the event. If you cannot submit 

complete information on a report, you must provide a statement 

explaining why this information was incomplete and the steps you took to 

obtain the information. If you later obtain any required information 

that was not available at the time you filed your initial report, you 

must submit this information in a supplemental report under Sec.  

803.56.