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.
FDA Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
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 document is intended to provide information to industry regarding the documentation that we recommend you include in premarket submissions for software devices, including stand-alone software applications and hardware-based devices that incorporate software
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