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Zdrowie i gospodarka · 15.11.2013

International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot Program; Availability

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.

Source: Federal Register — Food and Drug AdministrationOpen original release →