Aug 13, 2019

Les critères de la FDA étasunienne pour la cybersécurité des dispositifs médicaux et la gestion des risques

Concevoir la cybersécurité des dispositifs médicaux connectés et compatibles avec les logiciels en se basant sur les recommandations réglementaires.
Jan 19, 2013

US FDA veröffentlicht überarbeitete Liste der anerkannten Standards für Medizinprodukte

Die US Food and Drug Administration (FDA) hat Änderungen an der Liste der anerkannten Standards...
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.
Jan 17, 2013

US FDA Publishes Revised List of Recognized Medical Device Standards

The US Food and Drug Administration (FDA) has announced changes to the list of recognized standards the agency uses in the medical device regulatory process. Manufacturers should familiarize themselves with the revised FDA list in order to issue accurate Declarations of Conformity and ensure compliance with these standards as part of their US medical device registration efforts.
Dec 18, 2012

Neue FDA-Leitlinien zu Medizinprodukten für den Heimgebrauch

Von der US Food and Drug Administration wurden neue Leitlinien mit Informationen für Hersteller von
Dec 18, 2012

Verlängerung der Frist zur Erneuerung der US FDA Betriebsregistrierung

Die FDA hat vor kurzem bekanntgegeben, dass der jährliche Zeitrahmen zur Erneuerung der Betriebsregistrierung für Medizinprodukte um einen Monat verlängert wurde. Der Erneuerungszeitraum für die Registrierung für das Geschäftsjahr 2013 (1. Oktober 2012 bis 30. September 2013) sollte ursprünglich am 31. Dezember 2012 ablaufen. Dank der Verlängerung haben Hersteller nun bis 31. Januar 2013 Zeit, um Ihre Betriebsregistrierung zu verlängern.
Dec 13, 2012

US FDA Establishment Registration Renewal Deadline Extended

The FDA recently announced that the annual period for medical device establishment registration renewal has...
Dec 13, 2012

New FDA Guidance on Home Use Medical Devices

New guidance published by the US Food and Drug Administration advises manufacturers of “home use” medical devices on how to ensure compliance with safety and effectiveness requirements when designing their products.
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.
Oct 19, 2012

FDA to Require Electronic Filing of Medical Device Registration Submissions

The US Food and Drug Administration has published guidance outlining its plans for requiring medical device manufacturers to submit registration materials electronically via the agency’s eCopy Program. The eCopy Program is currently voluntary, but will become mandatory upon finalization of the proposed guidance as required by the Food and Drug Administration Safety and Innovation Act signed into law earlier in 2012. Once mandatory, the program will require manufacturers to submit eCopies along with standard application documents in order for the FDA to process and review them. Applications that do not include eCopies of their submissions will be put on hold until applicants provide eCopies.