by Jack Slovick | Aug 5, 2015 | FDA
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to implement changes to its Refuse to Accept (RTA) policy for 510(k) medical device submissions on October 1, 2015, according to new guidance from the agency. The latest RTA...
by Jack Slovick | Jul 31, 2015 | EU
European officials have published an updated list of recognized and harmonized standards in the Official Journal of the European Union, including standards pertaining to their medical device and IVD Directives. The first part of the new list deals with the Medical...
by Jack Slovick | Jan 13, 2015 | EU
The beginning of 2015 welcomes changes to the EU Commission website for medical devices, as well as new OJEU lists! Reorganization of EU Commission website Check your website bookmarks. The EU Commission has recently revised their medical devices...
