AG/FDA Blog

FDA Announces Medical Device Quality System Regulation Change

FDA recently announced a potential massive overhaul to its Medical Device regulations.  Specifically, the agency intends to “harmonize and modernize” its medical device Quality System Regulation (21 C.F.R. Part 820) with an international consens… Read More
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My Mobile Medical Application Will be Regulated by FDA…What Do I Do Now?

Recently, FDA finalized its guidance on Mobile Medical Applications (MMA), which is available here. The release of this guidance document lifted much of the regulatory uncertainty regarding which types of mobile apps FDA would and would not be active… Read More
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