[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.55]

[Page 59-60]
 
                        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 60]]

    (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.