[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: 21CFR803.55]



[Page 54-55]

 

                        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.  803.55  If I am a manufacturer, in what circumstances must I submit 

a baseline report, and what are the requirements for such a report?



    (a) You must submit a baseline report for a device when you submit 

the first report under Sec.  803.50 involving that device model. Submit 

this report on FDA Form 3417 or an electronic equivalent approved under 

Sec.  803.14.

    (b) You must update each baseline report annually on the anniversary 

month of the initial submission, after the initial baseline report is 

submitted. Report changes to baseline information in the manner 

described in Sec.  803.56 (i.e., include only the new, changed, or 

corrected information in the appropriate portion(s) of the report form). 

In each baseline report, you must include the following information:

    (1) Name, complete address, and establishment registration number of 

your reporting site. If your reporting site is not registered under part 

807, we will assign a temporary number for use in MDR reporting until 

you register your reporting site in accordance with part 807. We will 

inform you of the temporary MDR reporting number;

    (2) FDA registration number of each site where you manufacture the 

device;

    (3) Name, complete address, and telephone number of the individual 

who you have designated as your MDR contact, and the date of the report. 

For foreign manufacturers, we require a confirmation that the individual 

submitting the report is the agent of the manufacturer designated under 

Sec.  803.58(a);

    (4) Product identification, including device family, brand name, 

generic name, model number, catalog number, product code, and any other 

product identification number or designation;

    (5) Identification of any device that you previously reported in a 

baseline report that is substantially similar (e.g., same device with a 

different model number, or same device except for cosmetic differences 

in color or shape) to the device being reported. This includes 

additional identification of the previously reported device by model 

number, catalog number, or other product identification, and the date of 

the baseline report for the previously reported device;

    (6) Basis for marketing, including your 510(k) premarket 

notification number or PMA number, if applicable, and whether the device 

is currently the subject of an approved postmarket study under section 

522 of the act;

    (7) Date that you initially marketed the device and, if applicable, 

the date on which you stopped marketing the device;

    (8) Shelf life of the device, if applicable, and expected life of 

the device;



[[Page 55]]



    (9) The number of devices manufactured and distributed in the last 

12 months and an estimate of the number of devices in current use; and

    (10) Brief description of any methods that you used to estimate the 

number of devices distributed and the number of devices in current use. 

If this information was provided in a previous baseline report, in lieu 

of resubmitting the information, it may be referenced by providing the 

date and product identification for the previous baseline report.



    Effective Date Note: At 61 FR 39869, July 31, 1996, in Sec.  803.55, 

paragraphs (b)(9) and (10) were stayed indefinitely.