UDI Deadline Approaching

UDI Deadline Approaching

Are you ready for September 24, 2015? In just over a month, several categories of Class I and II devices will reach their compliance due date for labeling requirements under the Unique Device Identification (“UDI”) regulations. For companies with implantable,...
RTA Policy for 510(k) Submissions

RTA Policy for 510(k) Submissions

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...