
[Federal Register: January 5, 2010 (Volume 75, Number 2)]
[Notices]               
[Page 384-385]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja10-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0576]

 
Event Problem Codes Web Site; Center for Devices and Radiological 
Health; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a Web site where the Center for Devices and 
Radiological Health (CDRH) is posting updates to the problem codes used 
in conjunction with the medical device adverse event reports (MDR) 
regulation.

DATES:  Submit electronic or written comments at any time.

ADDRESSES:  Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Terrie L. Reed, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., rm. 3324, Silver Spring, MD 20993, 301-796-6130.

SUPPLEMENTARY INFORMATION:

I. Background

    Under part 803 (21 CFR part 803), user facilities and importers are 
required to submit FDA Form 3500A for deaths and serious injuries that 
a medical device may have caused or to which it may have contributed. 
Block F10 of FDA Form 3500A asks user facilities and importers to 
provide event problem codes for both the patient and the device. 
Manufacturers are required by Sec.  803.52(f)(11)(i) to include ``Any 
information missing on the user facility report or importer report, 
including any event codes that were not reported * * *.'' The patient 
problem codes indicate the effects that an event may have had on the 
patient, including signs, symptoms, syndromes, or diagnoses. The device 
codes describe device failures or issues related to the device that are 
encountered during the event. The medical device reporting regulation 
also states that if CDRH makes modifications to these reporting codes, 
the information will be made available to all reporters (Sec.  
803.21(b)).
    FDA is announcing the availability of a Web site that will make 
modifications to the problem codes available to all reporters and will 
also fully describe the problem codes. The Web site is located at 
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/
EventProblemCodes/default.htm. This Web site reflects the current 
updates to the problem codes, provides a description for each problem 
code, and notes that April 2, 2010, is the target date to reject all 
inactivated and retired codes specified in this update. After April 2, 
2010, no old codes or code numbers will be accepted. The Web site also 
describes a joint project between CDRH and the

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National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS) to 
improve the problem codes. The goals of this initiative are to 
streamline the patient and device problem codes, integrate FDA's 
problem codes into the NCI Thesaurus and Meta-Thesaurus, organize the 
vocabulary into a hierarchical format, and provide information that 
will assist reporters in requesting new codes, such as a mapping of 
inactivated or merged terms to preferred terms.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: December 11, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-31197 Filed 1-4-10; 8:45 am]

BILLING CODE 4160-01-S
