The US agency missed yet another internal deadline for publishing a draft of its revised Quality System Regulation. The FDA’s April 2020 target for releasing a draft is the third one it failed to meet; it has been working on harmonizing the QSR with ISO 13485 since mid-2018.
The US Food and Drug Administration has missed yet another internal deadline for publishing a draft of its retooled Quality System Regulation. The agency has been working on harmonizing its QSR with international quality systems standard ISO 13485 since mid-2018.
The FDA’s April 2020 deadline for releasing the draft is the third one it failed to meet. The agency...
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FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate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.
