Medmarc Blog (blog.medmarc.com) | Draft Guidance (4)

FDA, Draft Guidance, Intended Use, Off Label Promotion, Regulatory and Compliance

FDA Revisits Intended Use Rule | Medmarc

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...

3 minute read

FDA, COVID 19, Draft Guidance, Regulatory and Compliance

FDA Releases Final Guidance for Multiple Function Devices

August 14, 2020

After a wait of two years, the FDA has concluded the draft guidance for multiple function devices with a final version that makes several substantive changes. Among these is that the list of...

2 minute read

FDA, COVID 19, Draft Guidance, 510(k), Regulatory and Compliance

FDA to Resume Domestic Device Inspections

July 21, 2020

The FDA was forced to announce in March 2020 that it would suspend inspections of drug and medical device manufacturing sites because of the COVID-19 pandemic, but the agency has partially...

2 minute read

FDA, Draft Guidance, Regulatory and Compliance

FDA Inks Combo Product Feedback Guidance

January 29, 2020

The FDA and industry have been at loggerheads over various issues surrounding combination products, but a new draft guidance may help resolve some of those conflicts. The draft deals with...

2 minute read

Draft Guidance (4)

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FDA Revisits Intended Use Rule | Medmarc

FDA Releases Final Guidance for Multiple Function Devices

FDA to Resume Domestic Device Inspections

FDA Inks Combo Product Feedback Guidance