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By Mahnu Davar, Daniel Kracov, Abraham Gitterman, Abeba Habtemariam, Jennifer Madsen, Victoria Wallace
In early August 2016, the US FDA's Center for Device and Radiological Health issued a Draft Guidance for industry entitled Deciding When to Submit a 510(k) for a Software Change to an Existing Device.
By Daniel Kracov, Allison W. Shuren, Abraham Gitterman, Abeba Habtemariam
The final Guidance largely adopts CDRH's approach from its January 2015 draft.
By Mahnu Davar, Daniel Kracov
On August 24, 2016, the FDA published a proposed rule which would amend the decades-old regulations governing good laboratory practices for nonclinical laboratory studies.