[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Pages 78741-78742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31692]



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.


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.


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]