80_FR_78983 80 FR 78741 - Medical Device ISO 13485:2003 Voluntary Audit Report Pilot Program; Termination of Pilot Program; Announcement of the Medical Device Single Audit Program Operational Phase

80 FR 78741 - Medical Device ISO 13485:2003 Voluntary Audit Report Pilot Program; Termination of Pilot Program; Announcement of the Medical Device Single Audit Program Operational Phase

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 242 (December 17, 2015)

Page Range78741-78742
FR Document2015-31692

The Food and Drug Administration (FDA) is announcing the termination of the Medical Device ISO Voluntary Audit Report Pilot Program. This program allowed the submission of ISO audit reports performed by third parties, along with audit reports from the preceding 2 years, to determine if the owner or operator of the medical device establishment could be removed from FDA's routine inspection work plan for 1 year. FDA is also announcing its participation in the operational phase of the Medical Device Single Audit Program (MDSAP), which will allow third parties recognized by the MDSAP consortium to submit audit reports that FDA will utilize for routine inspections.

Federal Register, Volume 80 Issue 242 (Thursday, December 17, 2015) 
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78741-78742]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31692]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0226]


Medical Device ISO 13485:2003 Voluntary Audit Report Pilot 
Program; Termination of Pilot Program; Announcement of the Medical 
Device Single Audit Program Operational Phase

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
termination of the Medical Device ISO Voluntary Audit Report Pilot 
Program. This program allowed the submission of ISO audit reports 
performed by third parties, along with audit reports from the preceding 
2 years, to determine if the owner or operator of the medical device 
establishment could be removed from FDA's routine inspection work plan 
for 1 year. FDA is also announcing its participation in the operational 
phase of the Medical Device Single Audit Program (MDSAP), which will 
allow third parties recognized by the MDSAP consortium to submit audit 
reports that FDA will utilize for routine inspections.

DATES: This notice is effective March 31, 2016.

FOR FURTHER INFORMATION CONTACT: Robert Ruff, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3615, Silver Spring, MD 20993-0002, 301-796-6556.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 19, 2012 (77 FR 16036), FDA 
announced the availability of a final guidance entitled ``Guidance for 
Industry, Third Parties and Food and Drug Administration Staff: Medical 
Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program'' 
(Ref. 1). This guidance document was effective on June 5, 2012, and as 
stated in the guidance was an interim measure while developing a single 
audit program, to implement section 228 of the Food and Drug 
Administration Amendments Act of 2007 (Pub. L. 110-85), which amended 
section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 374(g)(7)). The pilot allowed the owner or operator of the 
medical device

[[Page 78742]]

establishment to be removed from FDA's routine inspection work plan for 
1 year from the last day of the ISO 13485:2003 audit. The voluntary 
submitted ISO 13485:2003 audit report provides FDA some information on 
the conformance of the manufacturer with basic and fundamental quality 
management system requirements for medical devices.
    In 2012, FDA started working on the MDSAP with other global 
regulators within the International Medical Device Regulators Forum 
(IMDRF) for purposes of leveraging work performed for other medical 
device regulators to meet its inspection obligations. On November 15, 
2013 (78 FR 68853), FDA announced its participation within the MDSAP 
consortium's pilot program, which is effective January 1, 2014, through 
December 31, 2016.
    After review of the MDSAP Mid-Pilot Report, which published in 
August 2015 (Ref. 2), FDA announced that it will participate with the 
other MDSAP Consortium regulators from Australia, Brazil, Canada, and 
Japan in the implementation of the operational phase of the program 
starting January 1, 2017. The MDSAP program provides FDA better 
assurances than the ISO 13485:2003 Voluntary Audit Report Submission 
Pilot because FDA's requirements under 21 CFR 820 or other FDA 
regulations typically covered during FDA inspections are encompassed 
within the MDSAP audit model.
    On January 1, 2017, MDSAP will become fully operational to include 
opening applications for additional auditing organizations beyond the 
limited eligible auditing organizations within the pilot phase. Each 
regulator within the consortium has committed to continuing to utilize 
the MDSAP audits during the pilot as well as during the operational 
phase as described in the MDSAP public announcements posted on FDA's 
Web page (Ref. 3).
    Also, Health Canada in a recent announcement laid out the timeframe 
for which they will terminate their Canadian Medical Device Conformity 
Assessment System (CMDCAS) program and utilize MDSAP as the means by 
which manufacturers will obtain a medical device license for 
distribution of medical devices in Canada (Ref. 4). As a result of the 
implementation of the MDSAP program, FDA will no longer accept ISO 
13485:2003 Voluntary Audit Report Submissions after March 31, 2016, to 
assist transitioning manufacturers over to MDSAP.

II. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852 and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

    1. FDA Guidance, Guidance for Industry, Third Parties and Food 
and Drug Administration Staff: Medical Device ISO 13485:2003 
Voluntary Audit Report Pilot Program, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM212798.pdf.
    2. Medical Device Single Audit Program (MDSAP) Mid-Pilot Status 
Report, January 2014-December 2016, available http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM461661.pdf.
    3. Medical Device Single Audit Program (MDSAP) Pilot, available 
at http://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/.
    4. Health Canada's transition strategy from CMDCAS to MDSAP, 
available at http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/index-eng.php.

    Dated: December 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31692 Filed 12-16-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices 78741 drug products with an approved new constitutes new safety information, the each year and that each rebuttal drug application (NDA) under section procedures involved in requiring safety statement will take approximately 6 505(b) of the FD&C Act, biological labeling changes, and enforcement of hours to prepare. products with an approved biologics the requirements for safety labeling In addition, in the guidance, FDA license application under section 351 of changes. states that new labeling prepared in the PHS Act, or prescription drug FDA requires safety labeling changes response to a safety labeling change products with an approved abbreviated by sending a notification letter to the notification should be available on the new drug application under section application holder. Under section application holder’s Web site within 10 505(j) of the FD&C Act if the reference 505(o)(4)(B), the application holder calendar days of approval. FDA must respond to FDA’s notification by estimates that approximately 407 listed drug with an approved NDA is submitting a labeling supplement or application holders will post new not currently marketed. Section notifying FDA that the applicant does labeling one time each year in response 505(o)(4) imposes timeframes for not believe the labeling change is application holders to submit and FDA to a safety labeling change notification warranted and submitting a statement and that the posting of the labeling will staff to review such changes, and gives detailing the reasons why the FDA new enforcement tools to bring take approximately 4 hours to prepare. application holder does not believe a about timely and appropriate labeling change is warranted (a rebuttal In the Federal Register of September changes. The guidance provides statement). 2, 2015 (80 FR 53161), FDA published information on the implementation of Based on FDA’s experience to date a 60-day notice requesting public the new provisions, including a with safety labeling changes comment on the proposed collection of description of the types of safety requirements under section 505(o)(4), information. No comments were labeling changes that ordinarily might we estimate that approximately 42 received. be required under the new legislation, application holders will elect to submit FDA estimates the burden of this how FDA plans to determine what approximately one rebuttal statement collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual responses per burden per Total hours respondents responses respondent response Rebuttal statement ............................................................... 42 1 42 6 252 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual Type of submission burden per Total hours respondents per disclosures disclosure respondent Posting approved labeling on application holder’s Web site 407 1 407 4 1,628 1 There are no capital costs or operating and maintenance costs associated with this collect of information. Dated: December 10, 2015. SUMMARY: The Food and Drug Administration, 10903 New Hampshire Leslie Kux, Administration (FDA) is announcing the Ave., Bldg. 66, Rm. 3615, Silver Spring, Associate Commissioner for Policy. termination of the Medical Device ISO MD 20993–0002, 301–796–6556. [FR Doc. 2015–31696 Filed 12–16–15; 8:45 am] Voluntary Audit Report Pilot Program. SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P This program allowed the submission of ISO audit reports performed by third I. Background parties, along with audit reports from In the Federal Register of March 19, DEPARTMENT OF HEALTH AND the preceding 2 years, to determine if 2012 (77 FR 16036), FDA announced the HUMAN SERVICES the owner or operator of the medical availability of a final guidance entitled device establishment could be removed ‘‘Guidance for Industry, Third Parties Food and Drug Administration from FDA’s routine inspection work and Food and Drug Administration plan for 1 year. FDA is also announcing Staff: Medical Device ISO 13485:2003 [Docket No. FDA–2010–D–0226] its participation in the operational Voluntary Audit Report Submission phase of the Medical Device Single Pilot Program’’ (Ref. 1). This guidance Medical Device ISO 13485:2003 Audit Program (MDSAP), which will document was effective on June 5, 2012, Voluntary Audit Report Pilot Program; allow third parties recognized by the and as stated in the guidance was an interim measure while developing a asabaliauskas on DSK5VPTVN1PROD with NOTICES Termination of Pilot Program; MDSAP consortium to submit audit Announcement of the Medical Device reports that FDA will utilize for routine single audit program, to implement Single Audit Program Operational inspections. section 228 of the Food and Drug Phase Administration Amendments Act of DATES: This notice is effective March 31, 2007 (Pub. L. 110–85), which amended AGENCY: Food and Drug Administration, 2016. section 704(g)(7) of the Federal Food, HHS. FOR FURTHER INFORMATION CONTACT: Drug, and Cosmetic Act (21 U.S.C. Robert Ruff, Center for Devices and 374(g)(7)). The pilot allowed the owner ACTION: Notice. Radiological Health, Food and Drug or operator of the medical device VerDate Sep<11>2014 18:13 Dec 16, 2015 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\17DEN1.SGM 17DEN1

78742 Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices establishment to be removed from II. References Analytical Sciences for Biotechnology FDA’s routine inspection work plan for The following references are on Health Products—WCBP 2016.’’ The 1 year from the last day of the ISO display in the Division of Dockets purpose of the meeting is to discuss 13485:2003 audit. The voluntary Management (HFA–305), Food and Drug development of biotechnology-derived submitted ISO 13485:2003 audit report Administration, 5630 Fishers Lane, Rm. drug products and analytic provides FDA some information on the 1061, Rockville, MD 20852 and are methodologies for the development of conformance of the manufacturer with available for viewing by interested biotechnology-derived drug products. basic and fundamental quality persons between 9 a.m. and 4 p.m., DATES: The meeting will be held January management system requirements for Monday through Friday; they are also 26, 2016, from 8 a.m., until January 28, medical devices. available electronically at http:// 2016, at 5 p.m. In 2012, FDA started working on the www.regulations.gov. FDA has verified ADDRESSES: The meeting will be held at MDSAP with other global regulators the Web site addresses, as of the date The Mayflower Hotel, 1127 Connecticut within the International Medical Device this document publishes in the Federal Ave. NW., Washington, DC Regulators Forum (IMDRF) for purposes Register, but Web sites are subject to FOR FURTHER INFORMATION CONTACT: of leveraging work performed for other change over time. Linda Mansouria, CASSS, 5900 Hollis medical device regulators to meet its 1. FDA Guidance, Guidance for Industry, St., Suite R3, Emeryville, CA 94608, inspection obligations. On November Third Parties and Food and Drug 510–428–0740, FAX: 510–428–0741, 15, 2013 (78 FR 68853), FDA announced Administration Staff: Medical Device ISO lmansouria@casss.org. its participation within the MDSAP 13485:2003 Voluntary Audit Report Pilot SUPPLEMENTARY INFORMATION: Program, available at http://www.fda.gov/ consortium’s pilot program, which is downloads/MedicalDevices/ I. Background effective January 1, 2014, through DeviceRegulationandGuidance/ December 31, 2016. CASSS is a scientific society GuidanceDocuments/UCM212798.pdf. 2. Medical Device Single Audit Program providing forums for the dissemination After review of the MDSAP Mid-Pilot of information and discussions among (MDSAP) Mid-Pilot Status Report, January Report, which published in August 2015 industry, academic and regulatory 2014–December 2016, available http:// (Ref. 2), FDA announced that it will www.fda.gov/downloads/MedicalDevices/ professionals founded on the participate with the other MDSAP InternationalPrograms/MDSAPPilot/ development and applications of Consortium regulators from Australia, UCM461661.pdf. separation science. This cosponsored Brazil, Canada, and Japan in the 3. Medical Device Single Audit Program meeting provides state-of-the-art implementation of the operational phase (MDSAP) Pilot, available at http:// presentations on the technologies used of the program starting January 1, 2017. www.fda.gov/MedicalDevices/ InternationalPrograms/MDSAPPilot/. to produce and assess product quality of The MDSAP program provides FDA 4. Health Canada’s transition strategy from biotechnology-derived drug products. better assurances than the ISO CMDCAS to MDSAP, available at http:// 13485:2003 Voluntary Audit Report II. Registration and Accommodations www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/ Submission Pilot because FDA’s index-eng.php. A. Registration requirements under 21 CFR 820 or other Dated: December 8, 2015. There is a registration fee to attend FDA regulations typically covered this meeting. The registration fee is Leslie Kux, during FDA inspections are charged to help defray the costs of Associate Commissioner for Policy. encompassed within the MDSAP audit programming and facilities. Seats are [FR Doc. 2015–31692 Filed 12–16–15; 8:45 am] model. limited, and registration will be on a BILLING CODE 4164–01–P On January 1, 2017, MDSAP will first-come, first-served basis. become fully operational to include To register, please complete opening applications for additional DEPARTMENT OF HEALTH AND registration online at http:// auditing organizations beyond the HUMAN SERVICES www.casss.org/?WCBP1600. (FDA has limited eligible auditing organizations verified the Web address, but FDA is not within the pilot phase. Each regulator Food and Drug Administration responsible for subsequent changes to within the consortium has committed to the Web site after this document [Docket No.FDA–2015–N–0001] continuing to utilize the MDSAP audits publishes in the Federal Register.) The during the pilot as well as during the The Twentieth Food and Drug costs of registration for the different operational phase as described in the Administration International categories of attendees are as follows: MDSAP public announcements posted Separation Science Society on FDA’s Web page (Ref. 3). Symposium on the Interface of Category Cost Also, Health Canada in a recent Regulatory and Analytical Sciences for Industry Rep- $1995 (early bird); announcement laid out the timeframe Biotechnology Health Products— resentatives. $2395 (onsite). for which they will terminate their WCBP 2016 Academic ........... $795 (early bird); Canadian Medical Device Conformity $895 (onsite). AGENCY: Food and Drug Administration, Government ....... $795 (early bird); Assessment System (CMDCAS) program HHS. and utilize MDSAP as the means by $895 (onsite). ACTION: Notice of meeting. which manufacturers will obtain a asabaliauskas on DSK5VPTVN1PROD with NOTICES medical device license for distribution SUMMARY: The Food and Drug B. Accommodations of medical devices in Canada (Ref. 4). Administration’s (FDA) Center for Drug Attendees are responsible for their As a result of the implementation of the Evaluation and Research, in own hotel accommodations. Attendees MDSAP program, FDA will no longer cosponsorship with the International making reservations at the Mayflower accept ISO 13485:2003 Voluntary Audit Separation Science Society (CASSS), is Hotel in Washington DC are eligible for Report Submissions after March 31, announcing a meeting entitled ‘‘The a reduced rate of $295 USD, not 2016, to assist transitioning Twentieth FDA CASSS Symposium on including applicable taxes. To receive manufacturers over to MDSAP. the Interface of Regulatory and the reduced rate, contact the Mayflower VerDate Sep<11>2014 16:53 Dec 16, 2015 Jkt 238001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\17DEN1.SGM 17DEN1


Document Created: 2018-03-02 09:18:59
Document Modified: 2018-03-02 09:18:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThis notice is effective March 31, 2016.
ContactRobert Ruff, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3615, Silver Spring, MD 20993-0002, 301-796-6556.
FR Citation80 FR 78741 
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