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510-k

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 publié des documents guides définitifs sur les changements apportés au matériel et aux logiciels des dispositifs médicaux qui nécessitent un nouveau 510 (k).
  • Ces directives définitives ne diffèrent pas sensiblement des versions provisoires publiées en 2016.

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 kontinuierliche Verbesserungen bei den Bearbeitungszeiten von 510(k)- und Premarket Approval-Anträgen (PMA, Genehmigung vor der Markteinführung) nachgewiesen werden.

Die Behörde führt dies auf den Anfang 2011 eingeführten 36-Punkte-Plan zur Verbesserung der Prüfverfahren vor der Markteinführung durch erhöhte Transparenz, Vorhersehbarkeit und Effizienz zurück.

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

The US Food and Drug Administration has published a new report showing small but consistent reductions in review times for 510(k) premarket notification as well as premarket approval (PMA) submissions for medical devices.

The regulator attributes these new timeframes to its 36-point Plan of Action begun in early 2011 to improve premarket review processes through increased transparency, predictability and efficiencies.

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.

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 that have not submitted US income tax returns--and also eliminated establishment registration fee discounts for small businesses as part of the agency’s updated Medical Device User Fees for 2013.