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Regulating Software As A Medical Device Will Take Paradigm Shift, Former FDA Chief Counsel Says

 
• By Hannah Daniel

Sidley Austin partner and former FDA Chief Counsel Jeff Senger told Medtech Insight that the FDA’s software pre-certification program will need to clear manufacturers, as well as software itself.

• Source: Shutterstock

Evidence is mounting that keeping up with software used as medical devices (SaMD) will require assessing manufacturers as well as their products.

Last month, the US Food and Drug Administration published a report on the software pre-certification pilot that it had launched...

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