Guideline: Quality System Information for Certain Premarket Application Reviews, Guidance for Industry
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| Titel: | Quality System Information for Certain Premarket Application Reviews, Guidance for Industry |
| Internet: | http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070899.pdf |
| Herkunft/Verlag: | FDA
http://www.fda.gov/cdrh/comp/guidance/1140.pdf |
| Inhalt: | Die Guideline diskutiert GMP-Anforderungen, die in eine PMA oder in ein PDP enthalten sein sollen. |
| Status: | Guidance |
| Dokumentenart: | Guideline |
