[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: 21CFR803.10]



[Page 43-44]

 

                        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 A_General Provisions

 

Sec.  803.10  Generally, what are the reporting requirements that apply 

to me?



    (a) If you are a device user facility, you must submit reports 

(described in subpart C of this part), as follows:



[[Page 44]]



    (1) Submit reports of individual adverse events no later than 10 

work days after the day that you become aware of a reportable event:

    (i) Submit reports of device-related deaths to us and to the 

manufacturer, if known; or

    (ii) Submit reports of device-related serious injuries to the 

manufacturers or, if the manufacturer is unknown, submit reports to us.

    (2) Submit annual reports (described in Sec.  803.33) to us.

    (b) If you are an importer, you must submit reports (described in 

subpart D of this part), as follows:

    (1) Submit reports of individual adverse events no later than 30 

calendar days after the day that you become aware of a reportable event:

    (i) Submit reports of device-related deaths or serious injuries to 

us and to the manufacturer; or

    (ii) Submit reports of device-related malfunctions to the 

manufacturer.

    (2) [Reserved]

    (c) If you are a manufacturer, you must submit reports (described in 

subpart E of this part) to us, as follows:

    (1) Submit reports of individual adverse events no later than 30 

calendar days after the day that you become aware of a reportable death, 

serious injury, or malfunction.

    (2) Submit reports of individual adverse events no later than 5 work 

days after the day that you become aware of:

    (i) A reportable event that requires remedial action to prevent an 

unreasonable risk of substantial harm to the public health, or

    (ii) A reportable event for which we made a written request.

    (3) Submit annual baseline reports.

    (4) Submit supplemental reports if you obtain information that you 

did not submit in an initial report.