Jul 9, 2019

FDA des États-Unis : règlement final pour l'appel des décisions règlementaires envers les dispositifs médicaux

La règle finale établit les procédures d'appel des décisions du CDRH en matière d'autorisation préalable à la mise en marché et d'approbation.
Feb 18, 2011

Battle Lines Drawn in Congressional Hearing on FDA Review Process

Business-friendly US lawmakers and the FDA’s Center for Devices and Radiological Health director Dr.
Feb 16, 2011

US Congress Wading into FDA Reform Debate

Opponents of the Food and Drug Administration’s reform efforts targeting medical device reviews have a sympathetic ear in Joe Pitts, the Republican congressman from Pennsylvania who now chairs the Hou
Feb 15, 2011

Recall Study Results Suggest 510(k) Reform Needed

A new study examining high-risk recall rates of medical devices in the US as added weight to contentions that the Food and Drug Administration’s
Feb 4, 2011

FDA's Approach to Mobile Devices Becoming Clearer

The US Food and Drug Administration (FDA) has cleared two mobile applications for use as...
Jan 31, 2011

FDA Panel: ECT Devices Require Further Testing

The US Food and Drug Administration’s Neurological Devices Advisory Committee came out last week in support of further testing of devices used in electroconvulsive therapy (ECT). ECT devices used i
Jan 19, 2011

FDA Reveals Some of its 510(k) Reforms

The US Food and Drug Administration (FDA) has rolled out the 510(k) premarket notification process...
Jan 19, 2011

FDA Unveils Some Elements of 510(k) Overhaul, Postpones Hot-button Issues

The US Food and Drug Administration (FDA) has rolled out some — but not all...
Jan 5, 2011

FDA Proposes Recordkeeping Requirements for Third-party 510(k) Reviewers

The US Food and Drug Administration (FDA) has proposed (Docket No. FDA–2010–N–0447) new rules targeting...
Dec 2, 2010

US FDA 510(k) Regulatory Process Update

Important changes are affecting the US FDA’s 510(k) process; namely the Transparency Initiative and the...