Medmarc Blog (blog.medmarc.com)
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Intended Use
Three Years Since the Draft Guidance was Released, FDA Issues their Final Guidance Document on Clinical Decision Support Software
October
25,
2022
On September 28, 2022, FDA released their 26-page final guidance document titled, “Clinical Decision Support Software.” This much anticipated final guidance document aims to set out which types...
FDA Revisits Intended Use Rule
October
07,
2020
The FDA’s policy for determining a manufacturer’s intended use has strained relations between the agency and industry in the past, but the agency said in a press release that the latest version...