The American Clinical Laboratory Association filed a citizen petition with FDA June 4 reiterating and formalizing its long-held opposition to FDA regulating laboratory-developed test services. The petition closely followed a speech from FDA Commissioner Hamburg emphasizing plans to do just that.
A controversial area of FDA diagnostics regulation gained renewed attention this week with a citizen petition sent to FDA from clinical laboratories and a speech from FDA Commissioner Margaret Hamburg.
The American Clinical Laboratory Association filed its citizen petition with FDA June 4 reiterating and formalizing its long-held...
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FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate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.
