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510(k)

États-Unis : la FDA souhaite des processus plus formalisés pour les demandes de classification De Novo

Par Stewart Eisenhart

LES POINTS PRINCIPAUX PAR EMERGO by UL :

  • La FDA étasunienne a proposé des politiques et des critères formels pour les demandes de classification des nouveaux dispositifs médicaux De Novo.
  • La voie de classification De Novo permet pour certains dispositifs à risque faible et modéré pour lesquels il n'est pas possible d'établir une équivalence substantielle d'obtenir l'accès au marché des États-Unis.
  • Les règles proposées fixeraient une période d'examen de 120 jours pour les demandes de classification De Novo.

FDA Reveals Some of its 510(k) Reforms

The US Food and Drug Administration (FDA) has rolled out the 510(k) premarket notification process for moderate-risk medical device clearance. The more polarizing aspects of the FDA’s plans, including establishing a new Class IIb device category requiring clinical information to support equivalence determinations as well as requiring postmarket surveillance studies as a condition of clearance for some devices, will not be finalized until after an independent report by the Institute of Medicine is issued later this year.

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 how third-party premarket notification (510(k)) reviewers appointed by the agency maintain relevant documents and records. Specifically, the FDA has submitted rules regarding the Third Party Review Program established under the Food and Drug Administration Modernization Act of 1997.