Baseline instructions

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Instructions for Completing Form 3417 - Medical Device Reporting Baseline Report

Issued: July 1, 1996
Revised: March 31, 1997

Under 21 CFR Part 803.55, the MDR regulation requires that manufacturers submit a baseline report on a device model the first time that model is the subject of a device report. The term model is used here generically to indicate a unique device that may be identified by a model number, catalog number or other device identification. The FDA has agreed, however, that in lieu of submitting a baseline report on an individual model, it will allow the submission of a baseline report on a device family.

Complete all items in Part 1 and all applicable items in Part 2.
Dates should be filled out in a MM/DD/YYYY format. (e.g. 07/31/1996).

PART 1

TYPE OF BASELINE REPORT: Check the "Initial" box if the submission is a new or "the first" baseline report for a device model. Otherwise check the "Annual Update" box.
FIRM INFORMATION (Reporting Site): In items 2a - 2g enter the firm name, FDA registration number or FDA assigned number and complete address of the designated site responsible for reporting adverse events to the FDA under the MDR regulation. (Enter NA in item 2g if it does not apply).
MANUFACTURER CONTACT INFORMATION: In items 3a - 3g enter the contact name, title, complete address and telephone number of the individual designated by the manufacturer as its MDR contact person for this requirement.
NUMBER OF "Baseline Reports - Part 2" attached: List the total number of individual Part 2 reports that are attached to this submission.
ARE YOU THE U.S. AGENT FOR A FOREIGN MANUFACTURER PER 21 CFR 803, 807?: The "YES" box should be checked if the individual listed in item 3a is the agent of a foreign manufacturer designated under Part 803.58(a).
SIGNATURE: The individual designated as the MDR contact person listed in item 3a must sign this form.
DATE: Enter the date that the baseline or annual update report was completed.

PART 2

Check if Initial Report or Annual Update. (Refer to Part 1, item 1 above).
List the FDA REGISTRATION NUMBER or FDA ASSIGNED NUMBER (Reporting Site) and DATE OF BASELINE REPORT as listed in Part 1, items 2b and 7.
Manufacturers who choose to submit baseline reports for a device family as described above, must enter device identification information in Part 2, items 2 - 8 for the first model of the family that was introduced into commerce, and attach a list providing the information as applicable, in items 2, 4, 5 or 6 for all other models in the family. At the top of the list, include the FDA registration number of the reporting site and the date of the baseline report as identified in Part 1, items 2b and 7, and the model identification initially entered in Part 2, items 4, 5 or 6. (A matrix has been attached at the end of these instructions that may be used as a guideline for reporting additional models on attached sheets).

MANUFACTURING SITE(S) FOR THIS DEVICE: List the FDA registration number and firm name of the manufacturing site for the device model being reported. If the device is manufactured at more than one site, list the FDA registration number and firm name for each location. If the manufacturing operations for a single device takes place at more than one site, select the principal site as the manufacturing site. If more space is required for either items 1a or 1b, attach a separate list including the FDA registration number of the reporting site and the date of the baseline report as identified in Part 1, items 2b and 7, and the model identification listed in Part 2, items 2, 4 or 6 at the top of the sheet.
DEVICE BRAND NAME: Enter the tradename or proprietary name of the device as used in the product labeling or catalog.
DEVICE GENERIC NAME: Enter the common name or generally descriptive name of the device, (i.e. heart valve, pacemaker, etc.).
DEVICE MODEL: Enter the model number exactly as it appears on the device labeling or packaging, or enter NA if the device does not have a model/catalog number.
DEVICE CATALOG NUMBER: Enter the catalog number exactly as it appears on the device labeling or packaging, or enter NA if the device does not have a model/catalog number.
OTHER DEVICE IDENTIFIER: Enter any other device product identification number as it appears on the device, its label or packaging, or enter NA if the device does not have an other identifier.
FDA PRODUCT CODE (FDA Classification name): Enter the product code assigned to the device based upon the medical device product classification designated under 21 CFR Parts 860-892. The device product codes are listed in the "Classification Names for Medical Devices and InVitro Diagnostic Products", HHS-Publication FDA 95-4246, dated March 1995; the Premarket Approval (PMA) letter; and since January 1, 1995, the product code may be found in the 510(k) substantially equivalent letter. If the device has been assigned more than one product code, select the one that would represent the most frequent use of the device or device family when reporting by device family. If you cannot identify a product code for the device, leave the field blank.
MANUFACTURER'S DEVICE FAMILY NAME: The device family name is the name assigned by the manufacturer to a group of one or more devices manufactured by, or for, the same manufacturer. In order to belong to a device family, the device must have the same basic design and performance characteristics related to device safety and effectiveness; intended use and function; device classification and product code. Devices that function in exactly the same way, have the same electrical and mechanical design and performance characteristics, have the same intended uses, and differ only cosmetically or in minor ways not related to device safety or effectiveness may be grouped as a family. Brand name, common name and whether the devices were introduced into commercial distribution under the same 510(k) or premarket approval (PMA) may be used as factors when grouping devices into families.
RELATED DEVICE IDENTIFICATION - (This item refers to devices included in a previous baseline report submitted on or after July 31, 1996). If this device, or a substantially similar device, was previously distributed with a different device identification, provide the following:
9a. Previous Device Identifier: The device model, catalog number or other alternative device identifier number as listed in the previously submitted baseline report.
9b. Type of Identifier: Check the appropriate box; "Model", "Catalog" or "Other".
9c. Date of Prior Baseline Report: The date of the previously submitted baseline report.
If the baseline report is being submitted based on device family rather than individual model or item 9 does not apply, then NA should be entered in item 9a and the remainder can be left blank.
BASIS FOR MARKETING: Check the appropriate boxes listed in items 10a - 10e. If "yes" is checked in either item 10a or 10b, provide the 510(k) or PMA number in the space provided. If the baseline report covers an individual model with more than one 510(k) or PMA number, enter the most recent submission number assigned to that model. If the baseline report covers a device family and there is more than one 510(k) or PMA number, enter the most recent submission number assigned to any model identified in the family.
. DEVICE LIFE: The shelf life of a device means the maximum time that a device will remain functional from the date of manufacture until it is used in patient care. The expected life of a device means the time that the device is expected to remain functional after it is placed into use.
11a. Enter the shelf life in months or check the box marked "N/A" if this does not apply and skip to item 11b. If the shelf life appears on the labeling check the box marked "yes", or check the box marked "no" if it does not.
11b. Enter the expected life in months or check "N/A" or "Not Established/Indefinite".
DATE DEVICE FIRST MARKETED: Enter the date that the device was initially marketed. If the exact date is unknown, an approximate date can be used. If the baseline report covers a device family and there is more than one market date, provide the date for the first model of the family that was marketed. If item 10c, "Preamendment" is checked "yes", skip this item.
DATE DEVICE CEASED BEING MARKETED (if applicable): Enter the date that the device ceased being marketed. If the exact date is unknown, an approximate date can be used. If the baseline report was submitted for a device family, do not enter a date unless the device family is discontinued. Future baseline reports would not be required once the device or device family has been discontinued.
IS THE DEVICE THE SUBJECT OF AN APPROVED POST MARKET (522) STUDY? Check "yes" if the device is the subject of an approved study under section 522 of the FD&C Act.
The data required in items 15a-c were stayed by the Federal Register Notice, dated July 31, 1996, and do not need to be completed at this time.
The data required in item 16 was stayed by the Federal Register Notice, dated July 31, 1996, and do not need to be completed at this time.

SPECIAL INSTRUCTIONS APPLICABLE TO THE ANNUAL UPDATE SUBMISSIONS

1.
Each annual update report must include:
A completed Part 1, items 1 - 7. (Check the "annual update" box in item 1).

All applicable items in Part 2 where an update or addition would be required.

In Part 2, check the "annual update" box and provide the FDA Registration Number and Date of Baseline Report as identified in Part 1, items 2b and 7.

If any new model(s) or previously reported model(s) is being manufactured at a location not reported in the initial baseline report, list the new site(s) in Part 2, item 1.

In Part 2, items 2-6 provide the product identifiers originally reported in the initial baseline report.

Attach a separate page listing the information requested in Part 2, items 2, 4, 5 and 6 for any additional model(s) added to the initial baseline report on a device family that was not previously submitted as part of the "interim" update described in item 3 below. At the top of the list, include the FDA registration number of the reporting site and the date of the baseline report update as identified in Part 1, items 2b and 7, and the model identification initially entered in Part 2, items 4, 5 or 6.

2.
The annual update report shall be submitted at the same time that the firm's annual registration is required per Part 807.21. However, if the annual registration is due less than six months after the initial baseline report is submitted, then the annual update report would not be required until the next annual registration is due.

Annual updates should cover the time period from the initial baseline report or last annual update, whichever is later, to the present filing.

3.
If a baseline report was submitted based on a device family and if, during the 12 month period after the submission of the initial baseline report or annual update report, a new model(s) is added to the device family that subsequently becomes the subject of a reportable adverse event and is reported under MDR, then an "interim" update report is required.

The "interim" update report shall contain the following information:

In Part 1, identify the update by typing/writing "Interim" in item 1, and provide the information in items 2-7.

In Part 2, list the FDA registration number and date of baseline report as identified in Part 1, items 2b and 7.

If the new model(s) is being manufactured at a location not previously reported in the initial baseline report, list the new site(s) in Part 2, item 1.

In Part 2, items 2-6 provide the product identifiers originally reported in the initial baseline report. Attach a separate page listing the information requested in Part 2, items 2, 4, 5 and 6 for any additional model(s). At the top of the list, include the FDA registration number of the reporting site and the date of baseline report update as identified in Part 1, items 2b and 7, and the model identification initially entered in Part 2, items 4, 5 or 6.

4.
An annual update to a baseline report does not have to be submitted if, during the 12 month reporting period, there were no changes and/or additions made to the information submitted in the initial baseline report, any interim update reports or annual updates.

This waiver remains in effect until such changes and/or additions are made. Then, an annual update report is required at the time of the next annual registration and shall contain the information identified in item 1. The update must include the designated information from the time that the initial baseline report and/or last update was filed to the present. This may be a period longer than 12 months.

5.
A matrix has been attached at the end of these instructions that may be used as a guideline for reporting additional models on attached sheets.

Matrix for identifying additional models on attached sheets:

Part 1 - Identification Information:

FDA Registration Number (item 2b) ________________________ Date (item 7)____________________

Part 2 - Initial Model ID from Items 4, 5 or 6:

Model No:___________________ Catalog No:__________________ Other ID No:__________________

New Model Information for Items 2, 4, 5 or 6:

Brand Name Model No. Catalog No. Other No.

Updated March 04, 1998

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Center for Devices and Radiological Health / CDRH

1.	Each annual update report must include: A completed Part 1, items 1 - 7. (Check the "annual update" box in item 1). All applicable items in Part 2 where an update or addition would be required. In Part 2, check the "annual update" box and provide the FDA Registration Number and Date of Baseline Report as identified in Part 1, items 2b and 7. If any new model(s) or previously reported model(s) is being manufactured at a location not reported in the initial baseline report, list the new site(s) in Part 2, item 1. In Part 2, items 2-6 provide the product identifiers originally reported in the initial baseline report. Attach a separate page listing the information requested in Part 2, items 2, 4, 5 and 6 for any additional model(s) added to the initial baseline report on a device family that was not previously submitted as part of the "interim" update described in item 3 below. At the top of the list, include the FDA registration number of the reporting site and the date of the baseline report update as identified in Part 1, items 2b and 7, and the model identification initially entered in Part 2, items 4, 5 or 6.
2.	The annual update report shall be submitted at the same time that the firm's annual registration is required per Part 807.21. However, if the annual registration is due less than six months after the initial baseline report is submitted, then the annual update report would not be required until the next annual registration is due. Annual updates should cover the time period from the initial baseline report or last annual update, whichever is later, to the present filing.
3.	If a baseline report was submitted based on a device family and if, during the 12 month period after the submission of the initial baseline report or annual update report, a new model(s) is added to the device family that subsequently becomes the subject of a reportable adverse event and is reported under MDR, then an "interim" update report is required. The "interim" update report shall contain the following information: In Part 1, identify the update by typing/writing "Interim" in item 1, and provide the information in items 2-7. In Part 2, list the FDA registration number and date of baseline report as identified in Part 1, items 2b and 7. If the new model(s) is being manufactured at a location not previously reported in the initial baseline report, list the new site(s) in Part 2, item 1. In Part 2, items 2-6 provide the product identifiers originally reported in the initial baseline report. Attach a separate page listing the information requested in Part 2, items 2, 4, 5 and 6 for any additional model(s). At the top of the list, include the FDA registration number of the reporting site and the date of baseline report update as identified in Part 1, items 2b and 7, and the model identification initially entered in Part 2, items 4, 5 or 6.
4.	An annual update to a baseline report does not have to be submitted if, during the 12 month reporting period, there were no changes and/or additions made to the information submitted in the initial baseline report, any interim update reports or annual updates. This waiver remains in effect until such changes and/or additions are made. Then, an annual update report is required at the time of the next annual registration and shall contain the information identified in item 1. The update must include the designated information from the time that the initial baseline report and/or last update was filed to the present. This may be a period longer than 12 months.
5.	A matrix has been attached at the end of these instructions that may be used as a guideline for reporting additional models on attached sheets.