[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.55]

[Page 53-54]
 
                        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. 803.55  Baseline reports.

    (a) A manufacturer shall submit a baseline report on FDA Form 3417, 
or electronic equivalent as approved by FDA under Sec. 803.14 for a 
device when the device model is first reported under Sec. 803.50.
    (b) Each baseline report shall be updated annually, on the 
anniversary month of the initial submission, after the initial baseline 
report is submitted.

[[Page 54]]

Changes to baseline information shall be reported 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). 
Baseline reports shall contain the following:
    (1) Name, complete address, and registration number of the 
manufacturer's reporting site. If the reporting site is not registered, 
FDA will assign a temporary registration number until the reporting site 
officially registers. The manufacturer will be informed of the temporary 
registration number;
    (2) FDA registration number of each site where the device is 
manufactured;
    (3) Name, complete address, and telephone number of the individual 
who has been designated by the manufacturer as its MDR contact and date 
of the report. For foreign manufacturers, a confirmation that the 
individual submitting the report is the agent of the manufacturer 
designated under Sec. 803.58(a) is required;
    (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 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, including the 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 510(k) premarket notification 
number or PMA number, if applicable, and whether the device is currently 
the subject of an approved post-market study under section 522 of the 
act;
    (7) Date the device was initially marketed and, if applicable, the 
date on which the manufacturer ceased marketing the device;
    (8) Shelf life, if applicable, and expected life of the device;
    (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 used to estimate the number of 
devices distributed and the method used to estimate 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.