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federal_register: 2013-27358

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2013-27358 International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot Program; Availability 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. 2013-11-15 2013 11 https://www.federalregister.gov/documents/2013/11/15/2013-27358/international-medical-device-regulators-forum-medical-device-single-audit-program-international https://www.govinfo.gov/content/pkg/FR-2013-11-15/pdf/2013-27358.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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