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510(k)

États-Unis : la FDA appuie les critères de performance 510 (k), et révise la politique des dispositifs prédicats

Par Stewart Eisenhart

LES POINTS PRINCIPAUX PAR EMERGO by UL :

  • La FDA étasunienne ouvre la voie d'enregistrement 510(k) Safety and Performance ;
  • Les critères de performance doivent jouer un plus grand rôle dans l'équivalence substantielle des dispositifs admissibles ;
  • Les politiques 510(k) relatives aux dispositifs prédicats doivent encore faire l'objet d'une révision.

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.