99-20140. Global Harmonization Task Force; Draft Document on Proposal for Reporting of Use Errors with Medical Devices; Availability  

  • [Federal Register Volume 64, Number 150 (Thursday, August 5, 1999)]
    [Notices]
    [Pages 42701-42702]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-20140]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    [Docket No. 99N092075]
    
    
    Global Harmonization Task Force; Draft Document on Proposal for 
    Reporting of Use Errors with Medical Devices; 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 Global Harmonization Task Force (GHTF) draft document 
    entitled ``Proposal for Reporting of Use Errors with Medical Devices.'' 
    The draft guidance includes information for regulatory authorities 
    about reporting of adverse events that result in death or serious 
    injury or certain types of near incidents. This draft document has been 
    prepared by members of the GHTF Study Group 2 (SG2) on Medical Devices 
    Vigilance/Postmarket Surveillance Reporting Systems. The draft document 
    represents a harmonized proposal. Elements of the approach set forth in 
    this draft document may not be consistent with current U.S. regulatory 
    requirements. FDA is requesting comments on this draft document.
    
    DATES:  Written comments by September 7, 1999. After the close of the 
    comment period, written comments may be submitted at any time to 
    Deborah Y. Blum (address below).
    
    ADDRESSES: Submit written comments on the draft document to the Dockets 
    Management Branch (HFA09305), Food and Drug Administration, 5630 
    Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be 
    identified with the docket number found in brackets in the heading of 
    this document. If you do not have access to the World Wide Web (WWW), 
    submit a written request for a 3.5'' diskette of the draft document 
    entitled ``Proposal for Reporting of Use Errors with Medical Devices'' 
    to the Division of Small Manufacturers Assistance (HFZ09220), Center 
    for Devices and Radiological Health, Food and Drug Administration, 1350 
    Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
    labels to assist that office in processing your requests, or fax your 
    request to 30109443098818. See the SUPPLEMENTARY INFORMATION section 
    for information on electronic access to the draft document.
    
    FOR FURTHER INFORMATION CONTACT:  Deborah Y. Blum, Office of 
    Surveillance and Biometrics (HFZ09520), Center for Devices and 
    Radiological Health, Food and Drug Administration, 9200 Corporate 
    Blvd., Rockville, MD 20850, 30109594092985.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Background
    
         FDA has participated in a number of activities to promote the 
    international harmonization of regulatory requirements, as described in 
    an FDA notice on these activities published in the Federal Register of 
    October 11, 1995 (60 FR 53078). As part of this effort, FDA has been 
    actively involved since 1992 with GHTF. GHTF has formed four study 
    groups, each tasked with assignments to draft documents and carry on 
    other activities, designed to facilitate global harmonization. The 
    purpose of this notice is to seek public comments on a draft document 
    that has been prepared by one of the GHTF study groups.
         SG2 was formed by GHTF in February 1996 and tasked with the 
    responsibility to examine the requirements for the reporting of adverse 
    incidents involving medical devices; consider postmarket surveillance 
    and other forms of vigilance; and recommend ways of harmonizing these 
    requirements. SG2 was also requested to promote the dissemination of 
    relevant information concerning these matters. SG2 helps to improve 
    protection of the health and safety to patients, users, and others; 
    evaluate reports and disseminate information which may reduce the 
    likelihood of or prevent repetitions of adverse events, or alleviate 
    consequences of such repetitions; and define postmarket medical device 
    reporting and surveillance requirements and guidelines on an 
    international basis.
         Reporting of adverse events involving medical devices is an 
    important element in any good postmarketing surveillance system and can 
    be achieved only through mutual confidence among all parties concerned. 
    The obligation to report adverse events differs widely among countries. 
    Some systems are voluntary, while others are mandatory. The common 
    thread that could tie all of the worldwide reporting systems together 
    is the obligation for manufacturers to report adverse events or 
    incidents of which they are aware that involve medical devices.
         It is the premise of the work of GHTF SG2 that an international 
    system for reporting adverse events can be developed to handle 
    information provided by the manufacturer to the authorities.
         FDA is announcing the availability of a draft document entitled 
    ``Proposal for Reporting of Use Errors with Medical Devices.'' The GHTF 
    SG2 has developed a reference for manufacturers regarding adverse event 
    reporting. This draft document is referenced as SG2 N21R8 . It includes 
    information for regulatory authorities about reporting of adverse 
    events that result in death or serious injury or certain types of near 
    incidents. It includes the consideration that certain types of failures 
    may be exempt from reporting under regulatory vigilance procedures, but 
    does not include a specific proposal on reporting of use errors. 
    ``Proposal for Reporting of Use Errors with Medical Devices'' gives an 
    overview on emerging process standards which are streamlining the 
    handling of use errors by industry and makes a proposal to regulatory 
    authorities on how to handle use errors under adverse event reporting 
    procedures.
    
     II. Electronic Access
    
         Persons interested in obtaining a copy of the draft document may 
    also do so using the WWW. CDRH maintains an entry on the WWW for easy 
    access to information including text, graphics, and files that may be 
    downloaded to a personal computer with access to the WWW. Updated on a 
    regular basis, the CDRH home page includes the the draft document 
    entitled ``Proposal for Reporting of Use Errors with Medical Devices,'' 
    device safety alerts, Federal Register reprints, information on 
    premarket submissions (including lists of approved applications and 
    manufacturers' addresses), small manufacturers' assistance, information 
    on videoconferencing and electronic submissions, mammography matters, 
    and other device-oriented information. The CDRH home page may be 
    accessed at ``http://www.fda.gov/cdrh''.
    
    III. Comments
    
         Interested persons may submit to the Dockets Management Branch 
    (address above) written comments regarding this draft document. Two 
    copies of any comments are to be submitted, except that individuals may 
    submit one copy. Comments should be identified with the docket number 
    found in brackets in the heading of this document. A copy of the draft 
    document and received comments are available for public examination in 
    the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
    Friday.
    
    [[Page 42702]]
    
         After September 7, 1999, written comments regarding the draft 
    document may be submitted at any time to the contact person (address 
    above).
    
        Dated: July 20, 1999.
    Linda S. Kahan,
    Deputy Director for Regulations Policy, Center for Devices and 
    Radiological Health.
    [FR Doc. 99-20140 Filed 8-4-99; 8:45 am]
    BILLING CODE 4160-01-F 
    
    
    

Document Information

Published:
08/05/1999
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
99-20140
Dates:
Written comments by September 7, 1999. After the close of the comment period, written comments may be submitted at any time to
Pages:
42701-42702 (2 pages)
Docket Numbers:
Docket No. 99N092075
PDF File:
99-20140.pdf