[Federal Register Volume 69, Number 32 (Wednesday, February 18, 2004)]
[Notices]
[Pages 7650-7652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0001]


Global Harmonization Task Force, Study Groups 1, 2, 3, and 4; New 
Proposed and Final Documents; 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 several proposed and final documents that have been 
prepared by Study Groups 1, 2, 3, and 4 of the Global Harmonization 
Task Force (GHTF). These documents are intended to provide information 
only and represent a harmonized proposal and recommendation from the 
GHTF Study Groups that may be used by governments developing and 
updating their regulatory requirements for medical devices. These 
documents are intended to provide information only and do not describe 
current regulatory requirements; elements of these documents may not be 
consistent with current U.S. regulatory requirements. FDA is requesting 
comments on these documents.

DATES: Submit written or electronic comments on any of the documents by 
May 18, 2004. After the close of the comment period, written or 
electronic comments may be submitted at any time to the contact persons 
listed in this document.

ADDRESSES: Submit written comments on the documents to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. 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 Internet, submit written 
requests for single copies on a 3.5 diskette of the document 
to the Division of Small Manufacturers, International and Consumer 
Assistance (HFZ-220), 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 301-443-8818. See the ELECTRONIC 
ACCESS section for information on electronic access to these documents.

FOR FURTHER INFORMATION CONTACT: 
    For Study Group 1: Ginette Michaud, GHTF, Study Group 1, Office of 
In Vitro Diagnostic Devices (HFZ-440), Center for Devices and 
Radiological Health, Food and Drug Administration, 2098 Gaither Rd., 
Rockville, MD 20850, 301-594-1293, ext 157;
    For Study Group 2: Deborah Yoder, GHTF, Study Group 2, Office of 
Surveillance and Biometrics (HFZ-520), Center for Devices and 
Radiological Health, Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850, 301-594-2985;
    For Study Group 3: Kimberly Trautman, GHTF, Study Group 3, Office 
of Compliance (HFZ-341), Center for Devices and Radiological Health, 
Food and Drug Administration, 2094 Gaither Rd., Rockville, MD. 20850, 
301-594-4659, ext. 126;
    For Study Group 4: M. Christine Nelson, GHTF, Study Group 4, Office 
of Health Industry Programs (HFZ-220), Center for Devices and 
Radiological Health, Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850, 301-443-6597, ext. 128.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has participated in a number of activities to promote the 
international harmonization of regulatory requirements. In September 
1992, a meeting was held in Nice, France by senior regulatory officials 
to evaluate international harmonization. At this

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time it was decided to form a GHTF to facilitate harmonization. 
Subsequent meetings have been held on a yearly basis in various 
locations throughout the world.
    The objective of the GHTF is to encourage convergence at the global 
level of regulatory systems of medical devices in order to facilitate 
trade while preserving the right of participating members to address 
the protection of public health by regulatory means considered most 
suitable. One of the ways this objective is achieved is by identifying 
and developing areas of international cooperation in order to 
facilitate progressive reduction of technical and regulatory 
differences in systems established to regulate medical devices. In an 
effort to accomplish these objectives, the GHTF has formed four study 
groups to draft documents and carry on other activities designed to 
facilitate global harmonization. This notice is a result of documents 
that have been developed by all four Study Groups (1, 2, 3, and 4).
    Study Group 1 was initially tasked with the responsibility of 
identifying differences between various regulatory systems. In 1995, 
the group was asked to propose areas of potential harmonization for 
premarket device regulations and possible guidance that could help lead 
to harmonization. As a result of their efforts, this group has 
developed SG1/N011R17, SG1/N015R22, SG1/N029R13, SG1/N041R6 and SG1/
N044R4. SG1/N011R17 (proposed document) ``Summary Technical 
Documentation for Demonstrating Conformity to the Essential Principles 
of Safety and Performance of Medical Devices (STED)'' applies to all 
products that fall within the definition of a medical device that 
appears within the GHTF document entitled ``Information Document 
Concerning the Definition of the Term `Medical Device' '' (SG1/N029R13, 
proposed document), other than those used for the in vitro examination 
of specimens derived from the human body. This guidance document 
provides guidance on Summary Technical Documentation (abbreviated to 
STED) for demonstrating conformity to the ``Essential Principles of 
Safety and Performance of Medical Devices'' (SG1/N020, final document). 
It describes the format for a globally harmonized STED and provides 
general recommendations on the content of the formatted elements.
    SG1/N015R22 (proposed document) ``Principles of Medical Devices 
Classification'' applies to all products that fall within the 
definition of a medical device that appears within the GHTF document 
``Information Document Concerning the Definition of the Term `Medical 
Device' '' (SG1/N029R13, proposed document), other than those used for 
the in vitro examination of specimens derived from the human body. The 
purpose of this document is to assist a manufacturer to allocate its 
medical device to an appropriate risk class using a set of harmonized 
rules.
    SG1/N029R13 (proposed document) ``Information Document Concerning 
the Definition of the Term `Medical Device' '' applies to all products 
that fall within the definition of a medical device, including those 
used for the in vitro examination of specimens derived from the human 
body. It provides a summary of the common ground found in the 
definition of the term ``medical device'' in different jurisdictions.
    SG1/N041R6 (proposed document) ``Essential Principles of Safety and 
Performance of Medical Devices (Including In Vitro Diagnostic 
Devices)'' applies to all products that fall within the definition of a 
medical device that appears within the GHTF document ``Information 
Document Concerning the Definition of the Term `Medical Device' '' 
(SG1/N029R13, proposed document), including those used for the in vitro 
examination of specimens derived from the human body. The purpose of 
this document is to describe generic product performance criteria, 
collectively referred to as ``essential principles'' that may be used 
to assess the safety of a particular medical device.
    SG1/N044R4 (proposed document) ``Role of Standards in the 
Assessment of Medical Devices (Including In Vitro Diagnostic Devices)'' 
applies to all products that fall within the definition of a medical 
device that appears within the GHTF document ``Information Document 
Concerning the Definition of the Term ``Medical Device'' (SG1/N029R13, 
proposed document), including those used for the in vitro examination 
of specimens derived from the human body. Its purpose is to describe 
the role of technical standards during the design of a medical device, 
as well as the role of standards in demonstrating that a device 
conforms to ``Essential Principles of Safety and Performance of Medical 
Devices'' (SG1/N020, final document).
    Study Group 2 was initially tasked with the responsibility of 
developing guidance documents that will be used for the exchange of 
adverse event reports. As a result of their efforts, this group has 
developed SG2/N31R8 and SG2/N32R5. SG2/N31R8 (final document) ``Medical 
Device Postmarket Vigilance and Surveillance: Proposal for Reporting of 
Use Errors With Medical Devices by their Manufacturer or Authorized 
Representative'' provides information to manufacturers and authorized 
representatives on factors to consider regarding the reporting of 
adverse events that are associated with use error. SG2/N32R5 (final 
document) ``Medical Device Postmarket Vigilance and Surveillance: 
Universal Data Set for Manufacturer Adverse Event Reports'' identifies 
and defines the various data elements that a manufacturer or authorized 
representative should include when filing a postmarket adverse event 
report to the national competent authority.
    Study Group 3 was initially tasked with the responsibility of 
developing guidance documents on quality systems. As a result of their 
efforts, this group has developed SG3/N99-10 and SG3/N15R6. ``Quality 
Systems--Process Validation Guidance,'' originally finalized in 1999, 
is being republished as ``GHTF/SG3/N99-10:2003 (Edition 2)'' after 
revisions due to the changes in ISO 13485:2003, which is utilized in 
some regulatory systems. The process validation guidance has been 
revised in sections 0 through 3.4, figure 1 and annex B. The revisions 
can be generalized in two categories: (1) Editorial revision of 
terminology to be consistent with ISO 13485:2003 (i.e., ``quality 
system'' to ``quality management system'' and ``design controls'' to 
``design and development controls''), and (2) changes to figure 1 and 
the corresponding text to reflect the new process validation 
requirements found in clause 7.5.2 of ISO 13485:2003. This process 
validation guidance is intended to assist manufacturers in 
understanding quality management system requirements concerning process 
validation and has general applicability to manufacturing (including 
servicing and installation) processes for medical devices. The guidance 
provides general suggestions on ways manufacturers may prepare for and 
carry out process validations. This guidance does not suggest 
particular methods of implementation, and therefore, should not be used 
to assess compliance with quality management system requirements. 
Rather the intent is to expand on quality management system 
requirements with practical explanations and examples of process 
validation principles. Manufacturers can and should seek out/select 
technology-specific guidance on applying process validation to their 
particular situation.
    SG3/N15R6 ``Risk Management as an Integral Part of the Quality 
Management System'' is intended to assist medical

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device manufacturers with the integration of risk management concepts 
into their quality management system by providing practical 
explanations and examples. It is based on general principles of a 
quality management system and general principles of a risk management 
system and not on any particular standard or regulatory requirement. 
This document has general applicability to quality management systems 
for organizations providing medical devices. This document will discuss 
risks related to product safety, rather than other business risks. The 
integration of risk management into the quality management system is 
applicable to all stages of the life cycle of a medical device. This 
guidance does not suggest particular methods of implementation and 
therefore should not be used to assess or audit compliance with 
regulatory requirements.
    Study Group 4 was initially tasked with the responsibility of 
developing auditing guidelines. These guidelines are intended to 
provide guidance on regulatory auditing of quality systems of medical 
device manufacturers. As a result of their efforts, this group has 
developed SG4/N30R6 (proposed document) entitled ``Guidelines for 
Regulatory Auditing of Quality Systems of Medical Device Manufacturers-
-Part 2: Regulatory Auditing Strategy.'' This document is intended to 
be used by regulatory auditing organizations and auditors as a guide 
for conducting medical device quality systems audits based on the 
process approach to quality management of ISO 13485:2003. Additional 
regulatory requirements and guidance will need to be considered, 
depending on the regulatory authorities who will receive and use the 
audit report. This guidance document applies to initial audits and to 
surveillance audits as they are defined in ``Guidelines for Regulatory 
Auditing of Quality Systems of Medical Device Manufacturers--Part I: 
General Requirements (SG4/N28R2)''--including the supplements--
developed by GHTF Study Group 4 as a guide for auditing organizations.
    These documents represent recommendations from the GHTF Study 
Groups and do not describe regulatory requirements. FDA is making these 
documents available so that industry and other members of the public 
may express their views and opinions.

II. Electronic Access

    Persons interested in obtaining copies of these draft documents may 
also do so using the Internet. Updated on a regular basis, the CDRH 
home page includes device safety alerts (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video-oriented conferencing and electronic 
submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. Information on the GHTF may be accessed at http://www.ghtf.org.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding any of these 
documents. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document and 
with the full title of these documents. The draft documents and 
received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 4, 2004.
Lillian J. Gill,
Acting Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-3412 Filed 2-17-04; 8:45 am]
BILLING CODE 4160-01-S