§ 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 § 803.50 involving that device model. Submit this report on FDA Form 3417 or an electronic equivalent approved under § 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 § 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 § 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;

(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.