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GUIDANCE DOCUMENT

Variance from Manufacturer Report Number Format - No. 5 August 1996

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
DATE:August 12, 1996
TO:Medical Device Manufacturers
FROM:Deputy Director, Office of Surveillance and Biometrics
Center for Devices and Radiological Health, FDA
SUBJECT:VARIANCE FROM MANUFACTURER REPORT NUMBER FORMAT


The Office of Surveillance and Biometrics, CDRH, has received several requests from manufacturers to add a new variance which would authorize a firm to use the Facility Registration Number of the reporting site in place of the Facility Registration Number of the manufacturing site of an affected device. Therefore, under the authority of 21 CFR Part 803.19(c), the following variance may be used by manufacturers when filling out form 3500A for reportable adverse medical device reports (MDRs):
 

VARIANCE NO. 5 (V1996005): Manufacturers who have one or more reporting site locations may use the Facility Registration Number of those sites in place of the Facility Registration Number of the manufacturing site of the affected device. In this case, the manufacturer report number requested on MedWatch form 3500A will consist of the reporting site facility registration number, the 4-digit calendar year in which the report was submitted and a 5-digit sequence number. In order to take advantage of this variance, the registration number and address of the manufacturing site of the affected device must be listed in Block G1 of the form.
 

If you have any questions regarding this variance, please contact the Reporting Systems Monitoring Team at: (301) 594-2735, Fax no. (301) 827-0038 or write to:
 

Reporting Systems Monitoring Team, HFZ-533
Division of Surveillance Systems
Office of Surveillance and Biometrics
1350 Piccard Drive
Rockville, MD 20850

Email: rsmb@cdrh.fda.gov


 

Susan N. Gardner, Ph.D.

 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.