Nov 7, 2017

La directive définitive de la FDA pour savoir quand les changements apportés aux dispositifs médicaux exigent un nouveau 510 (k)

Écrit par Stewart Eisenhart LES POINTS PRINCIPAUX PAR EMERGO : La FDA des États-Unis a...
Aug 28, 2013

New US Guidance on Good Laboratory Practice Compliance for 510(k) and PMA Submissions

New draft guidance from the US Food and Drug Administration addresses how Good Laboratory Practice...
Feb 28, 2013

FDA schlägt Vereinheitlichung der Anforderungen für klinische Daten vor

Die US Food and Drug Administration hat einen Vorschlag veröffentlicht, in dem gefordert wird, dass b
Feb 27, 2013

FDA Proposes More Consistent Clinical Data Requirements

The US Food and Drug Administration has published a proposed rule that would require medical device c
Jan 19, 2013

Übersicht über die neue Richtlinie zur Annahmeverweigerung von 510(k)-Anträgen der US FDA

Die revidierte Richtlinie zur Annahmeverweigerung (Refuse to Accept
Jan 17, 2013

Primer on US FDA’s New 510(k) Refuse to Accept Policy

The US Food and Drug Administration’s revised Refuse to Accept (RTA) policy is now in effect. The RTA policy involves an early review of 510(k) applications to determine whether they are “administratively complete,” or contain all materials necessary for the regulator to conduct a substantive review.
Dec 14, 2012

FDA-Bericht: nun schnellere Bearbeitung von 510(k)- und PMA-Anträgen

Die US Food and Drug Administration hat einen neuen Bericht veröffentlicht, in dem geringe, jedoch...
Dec 11, 2012

FDA Report Claims Improved 510(k), PMA Review Times

The US Food and Drug Administration has published a new report showing small but consistent...
Oct 24, 2012

New 510(k) Timeframe and Performance Goals at US FDA

The US Food and Drug Administration has set new review timeframes and performance goals for 510(k) premarket notification reviews of medical devices following Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. By 2017, the agency intends to reduce the average total time for 510(k) decisions to 124 days from 150 days for fiscal year 2012.
Aug 6, 2012

US FDA Opens Small-Business Medical Device User Fee Discounts to More Foreign Manufacturers

The US Food and Drug Administration has opened small business qualification to foreign companies--including those...