FDA issues a draft guidance July 15 describing how it weighs the risks and benefits to prove substantial equivalency in 510(k) devices when the new product’s technological characteristics differ from its predicate device.
A new FDA draft guidance
lays out the steps it uses to assess risks and benefits for “substantial equivalency” of devices when they have different...
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Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
