In the last year the FDA has taken steps to evolve its process for regulating software as a medical device, personal genomics and clinical decision support technology. In many ways the gatekeepers of healthcare innovation and advancement in the US, the FDA is key in shaping the future of the healthcare industry both in America and abroad. When it comes to the digital space the FDA has been evolving both in the way technology is approved and vetted.Over the last year FDA Commissioner Scott Gottlieb has put an emphasis on speeding up the process in getting technology and medications out to the public. This is evidenced by the new Pre-Cert program which would uproot the way software as a medical device is regulated, with the possibility of deeming a company safe instead of focusing on each individual product.

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