May ,07 2019

Final FDA Q-Submission guidance includes medical device cybersecurity coverage

EMERGO BY UL SUMMARY OF KEY POINTS: US FDA publishes
Jan ,19 2013

US FDA veröffentlicht überarbeitete Liste der anerkannten Standards für Medizinprodukte

Die US Food and Drug Administration (FDA) hat Änderungen an
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
Dec ,13 2012

US FDA Establishment Registration Renewal Deadline Extended

The FDA recently announced that the annual period for medical
Dec ,13 2012

New FDA Guidance on Home Use Medical Devices

New guidance published by the US Food and Drug Administration
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.

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