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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Quality System Information
for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff |
| Internet: | http://www.fda.gov/cdrh/comp/guidance/1140.pdf |
| Origin/Publisher: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ |
| Content: | This guidance has been prepared by the Center for Devices and Radiological Health (CDRH), in coordination with the Center for Biologics Evaluation and Research (CBER), to assist medical device manufacturers in preparing and maintaining the QS information required in premarket submissions1.
This guidance replaces “Guidance for Preparation |
| Status: | Guidance |
| Document Type: | Guidance |
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