The agency has granted a petition from trade groups to delay controversial revisions to its definition of “intended use” for at least one year, and is also gathering comments to guide possible further revisions.
FDA has delayed implementation of proposed changes to its definition of “intended use” by one year in the face of significant stakeholder protest.
A final rule published Jan. 9 would have broadened the definition of “intended use” to what is called the “totality...
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FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate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.
