
[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Notices]
[Pages 68853-68854]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27358]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1306]


International Medical Device Regulators Forum; Medical Device 
Single Audit Program International Coalition Pilot Program; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing 
participation in the Medical Device Single Audit Program International 
Coalition Pilot Program. The Medical Device Single Audit Program 
(MDSAP) was designed and developed to ensure a single audit will 
provide efficient yet thorough coverage of the diverse international 
regulatory requirements of medical devices quality management systems 
and other specific regulatory requirements of the regulatory 
authorities participating in the pilot program. FDA will be 
participating in the MDSAP and will accept the resulting audit reports 
as a substitute for routine Agency inspections.

ADDRESSES: Submit electronic comments on the MDSAP International 
Coalition Pilot Program 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: Kimberly A. Trautman, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5400, Silver Spring, MD 20993-0002, 
301-796-5515, Kimberly.Trautman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The International Medical Device Regulators Forum (IMDRF) was 
conceived in 2011 as a forum to discuss future directions in medical 
device regulatory harmonization. It is a voluntary group of medical 
device regulators from around the world, which includes FDA, who have 
come together to build on the strong foundational work of the Global 
Harmonization Task Force on Medical Devices. The purpose of the IMDRF 
is to accelerate international medical device regulatory harmonization 
and convergence. See http://www.imdrf.org/.
    The IMDRF recognizes the value in developing a global approach to 
auditing and monitoring the manufacturing of medical devices to ensure 
safe medical devices. The IMDRF, at its inaugural meeting in Singapore 
in 2012, identified a Work Group (WG) to develop specific documents for 
advancing the concept of the MDSAP. See http://www.imdrf.org/.
    This global approach opens possibilities and pathways to support 
the development of an international initiative of countries dedicated 
to pooling technology, resources, and services to improve the safety 
and oversight of medical devices on an

[[Page 68854]]

international scale in a pilot program starting in January 2014. The 
international partners for the MDSAP pilot, Therapeutic Goods 
Administration of Australia, Brazil's Ag[ecirc]ncia Nacional de 
Vigil[acirc]ncia Sanit[aacute]ria, Health Canada, FDA, and Japan's 
Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical 
Devices Agency, are official observers and active participants in the 
pilot program's Regulatory Authority Council and subject matter expert 
groups.
    The mission of the participants in the MDSAP International 
Coalition is to jointly leverage regulatory resources to manage an 
efficient, effective, and sustainable single audit program focused on 
the oversight of medical device manufacturers. The development of the 
MDSAP includes the use of third party auditors, much like some current 
regulatory audit programs, as well as regulatory inspectorates. 
Recognizing the increasingly global nature and number of medical device 
manufacturers, the use of third party auditors in addition to 
regulatory authority inspectorates, allows greater coverage in auditing 
manufacturers as opposed to relying solely on the government resources 
of individual countries. The government resources can then be focused 
on high risk or problematic medical devices, manufacturers that are not 
in compliance with the regulations, and oversight of the third party 
auditing organizations. The MDSAP Pilot is intended to allow MDSAP-
recognized auditing organizations to conduct a single audit of a 
medical device manufacturer that will satisfy the relevant requirements 
of the medical device regulatory authorities participating in the 
pilot.
    The regulatory authorities involved in the pilot will base their 
recognition and assessment process on the following final IMDRF MDSAP 
documents:
     IMDRF MDSAP WG N3--``Requirements for Medical Device 
Auditing Organizations for Regulatory Authority Recognition;''
     IMDRF MDSAP WG N4--``Competence and Training Requirements 
for Auditing Organizations;''
     IMDRF MDSAP WG N5--``Regulatory Authority Assessment 
Method for the Recognition and Monitoring of Medical Device Auditing 
Organizations;'' and
     IMDRF MDSAP WG N6--``Regulatory Authority Assessor 
Competency and Training Requirements.''
    Each of these documents was proposed in draft by the IMDRF and 
comments were solicited. IMDRF is in the process of revising these 
documents based on comments received. The IMDRF MDSAP Working Group has 
submitted the four proposed final documents for the IMDRF Management 
Committee meeting in Brussels on November 12 to14, 2013.
    The proposed drafts for each document are not available during the 
revision process. When final, these documents will be available on the 
IMDRF Web site (see http://www.imdrf.org/).
    In addition, the MDSAP International Coalition has also developed 
several documents in order to implement the pilot. As documents are 
finalized by the MDSAP International Coalition Regulatory Authority 
Council, the documents will be posted on FDA's Web site.
    The MDSAP audit process was designed and developed to ensure a 
single audit will provide efficient yet thorough coverage of the 
requirements of medical devices. FDA will accept the MDSAP audit 
reports as a substitute for routine Agency inspections. Inspections 
conducted ``For Cause'' or ``Compliance Followup'' by FDA will not be 
affected by this program. Moreover, this MDSAP Pilot would not apply to 
any necessary preapproval or postapproval inspections for Premarket 
Approval (PMA) applications or to decisions under section 513(f)(5) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(5)) 
concerning the classification of a device.

III. Electronic Access

    Additional information on the IMDRF MDSAP can be found at: http://www.imdrf.org/ and at http://www.fda.gov/MedicalDevices/.

V. Comments

    Interested persons may submit either electronic comments regarding 
the MDSAP International Coalition Pilot Program to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: November 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27358 Filed 11-14-13; 8:45 am]
BILLING CODE 4160-01-P


