The medical imaging device group, MITA, has voiced support for legislation that calls for clarity on activities that fall under medical device remanufacture. Currently, the definition of remanufacture could be misinterpreted and could lead to some devices being improperly changed without oversight. Defining medical device remanufacture would occur in a collaborative effort with FDA and Congress. The bill, H.R. 7253, The Clarifying Remanufacturing to Protect Patient Safety Act of 2022, was introduced earlier this month.
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