International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot Program; Availability, 68853-68854 [2013-27358]

Download as PDF Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Notices FOR FURTHER INFORMATION CONTACT: emcdonald on DSK67QTVN1PROD with NOTICES Lauren Posnick Robin, Center for Food Safety and Applied Nutrition (HFS– 317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1639. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance entitled ‘‘Guidance for Industry: Acrylamide in Foods.’’ We are issuing this draft guidance as a Level 1 draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on acrylamide in foods. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. The draft guidance is intended to provide information that may help growers, manufacturers, and food service operators reduce acrylamide in certain foods. Acrylamide is a chemical that can form in some foods during certain types of high-temperature cooking, and is a concern because it can cause cancer in laboratory animals at high doses, and is reasonably anticipated to be a human carcinogen. Reducing acrylamide in foods may mitigate potential human health risks from exposure to acrylamide. The draft guidance is intended to suggest a range of possible approaches to acrylamide reduction and not to identify specific recommended approaches. In particular, the draft guidance is intended to give information to manufacturers on selecting and handling raw materials, modifying processing practices, and choosing ingredients, so as to reduce acrylamide in potato-based foods (such as fries, sliced potato chips, and fabricated potato chips) and cereal-based foods (such as cookies, crackers, and breads). The draft guidance also discusses acrylamide reduction in coffee. The draft guidance also is intended to give information to manufacturers for placing preparation and cooking instructions on frozen French fry packages. Lastly, the draft guidance is intended to give information for food service operations on preparation of potato-based and cereal-based foods. II. Paperwork Reduction Act of 1995 This draft guidance contains proposed information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 VerDate Mar<15>2010 16:58 Nov 14, 2013 Jkt 232001 (the PRA) (44 U.S.C. 3501–3520). ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Federal law at 44 U.S.C. 3506(c)(2)(A) requires Federal Agencies to publish a 60-day notice in the Federal Register for each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, we will publish a 60-day notice of the proposed collection of information in a future issue of the Federal Register. III. Comments Interested persons may submit either electronic comments regarding the draft guidance 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. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the draft guidance. Dated: November 12, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–27362 Filed 11–14–13; 8:45 am] BILLING CODE 4160–01–P 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. The Food and Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 68853 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 E:\FR\FM\15NON1.SGM 15NON1 emcdonald on DSK67QTVN1PROD with NOTICES 68854 Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Notices international scale in a pilot program starting in January 2014. The international partners for the MDSAP pilot, Therapeutic Goods Administration of Australia, Brazil’s ˆ ˆ Agencia Nacional de Vigilancia ´ Sanitaria, 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.’’ VerDate Mar<15>2010 16:58 Nov 14, 2013 Jkt 232001 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. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1038] Over-the-Counter Ophthalmic Drug Products—Emergency Use Eyewash Products; Rescheduling of Public Hearing AGENCY: Food and Drug Administration, HHS. Notice; rescheduling of public hearing. ACTION: The Food and Drug Administration (FDA) is rescheduling a December 4, 2013, public hearing to obtain information on the formulation, manufacturing, and labeling of currently marketed over-the-counter (OTC) emergency use eyewash products, announced in the Federal Register of Wednesday, September 18, 2013. Based on a request received by the Agency, we are rescheduling the public hearing to March 7, 2014, and updating the related procedural dates that appeared in the September 18, 2013, notice. DATES: The public hearing will be held on March 7, 2014, from 9 a.m. to 5 p.m. Submit electronic or written requests to make oral presentations and comments by February 14, 2014. If you wish to attend the hearing or make an oral presentation during the hearing, you must register by submitting an electronic request to CDEREYEWASHMEETING@fda.hhs.gov by close of business on February 14, 2014. For those unable to attend in person, FDA will provide a Webcast to the meeting; additional information about the Webcast location will be posted on the Web page at http:// www.fda.gov/Drugs/NewsEvents/ ucm356526.htm prior to March 7, 2014. Electronic or written comments will be accepted after the hearing until June 6, 2014. FOR FURTHER INFORMATION CONTACT: Mary C. Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301–796–3519, FAX: 301–847– 8753, mary.gross@fda.hhs.gov; or Elaine Abraham, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire SUMMARY: E:\FR\FM\15NON1.SGM 15NON1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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