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Instructions for Completing Form 3417 - Medical Device Reporting Baseline Report |
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.
PART 1
PART 2
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.
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".
SPECIAL INSTRUCTIONS APPLICABLE TO THE ANNUAL
UPDATE SUBMISSIONS
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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. |
1.
Updated March 04, 1998
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