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Food and Drug Administration

US FDA’s Pre-Cert Pilot for Medical Device Software Moving into Testing Phase


  • US FDA has issued a new regulatory framework, working model and test plan for its Pre-Cert pilot program for Software as a Medical Device (SaMD).
  • The FDA Pre-Cert regulatory pathway would utilize FDA’s De Novo classification request framework for qualifying SaMD products.
  • FDA is accepting comments on these Pre-Cert updates through March 8, 2019.

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.

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.

US FDA Establishment Registration Renewal Deadline Extended

The FDA recently announced that the annual period for medical device establishment registration renewal has been extended by one month. The fiscal year 2013 (October 1, 2012 through September 30, 2013) registration renewal period was originally scheduled to end on December 31, 2012. Thanks to the extension, manufacturers now have until January 31, 2013 to renew their establishment registration.

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.

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.