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2013-11-15
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International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot Program; Availability
Notices
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D09002ee1bdc8f3a3
United States
Department of Health and Human Services
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United States
Food and Drug Administration
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United States Government Agency or Subagency
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.
78 FR 68853
https://www.govinfo.gov/app/details/FR-2013-11-15/2013-27358
2013-27358
fr15no13-80
4160-01-P
Docket No. FDA-2013-N-1306
https://www.govinfo.gov/app/details/FR-2013-11-15/2013-27358
https://www.govinfo.gov/content/pkg/FR-2013-11-15/html/2013-27358.htm
https://www.govinfo.gov/content/pkg/FR-2013-11-15/pdf/2013-27358.pdf
2 p.
68853
68854
78 FR 68853
International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot Program; Availability; Federal Register Vol. 78, Issue
NOTICE
2013-27358
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-N-1306
4160-01-P
2013-27358
Notice.
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.
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.
Medical Device Single Audit Program International Coalition Pilot Program
,
Kimberly.Trautman@fda.hhs.gov
http://www.fda.gov/MedicalDevices/
http://www.imdrf.org/
http://www.regulations.gov
Federal Register
Vol. 78, no. 221
Office of the Federal Register, National Archives and Records Administration
2013-11-15
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2013-11-15
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https://www.govinfo.gov/content/pkg/FR-2013-11-15/pdf/FR-2013-11-15.pdf
https://www.govinfo.gov/content/pkg/FR-2013-11-15/xml/FR-2013-11-15.xml
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