E9-31197. Event Problem Codes Web Site; Center for Devices and Radiological Health; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 § 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 (§ 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 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.