HHS committee aims to limit FDA oversight of HIT products

08/13/2013 | BeckersHospitalReview.com

Health IT products, with some exceptions, should not be subject to FDA premarket requirements, according to an HHS workgroup asked to create a strategy for these products that would promote innovation while also ensuring patient safety. The workgroup did note that medical device accessories and some high-risk solutions should fall under FDA review. It also recommended post-market safety testing and a public reporting process for HIT products.

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