November 2012 CDRH is now accepting web-based applications for Certificates to Foreign Government. The web-based applications are to be submitted electronically through the CDRH Export Certification Application and Tracking System (CECATS). CDRH purports that use of CECATS for CFG applications will offer several benefits, including a reduction in certificate processing time (CFG’s are projected to […]
<h1 class="entry-title">Author: <span class="vcard">ComplianceAcuity</span></h1>
FDA publishes a revised UDI proposed rule
November 2012 On November 19, 2012, FDA published a revised UDI proposed rule to accommodate the enactment of FDASIA, which was signed into law (Pub. L. 112–144) on July 9, 2012. Specifically, pursuant to FDASIA, the purpose of the revised UDI proposed rule is to specify the date by which a proposed rule is required, […]
FDA announces significant changes to device registration and listing system
August 2012 For updates from the European Commission regarding revision of the European MDD, click the link below: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm
Wondering how FDA’s UDI rule might affect labelers? Here’s a non-exhaustive summary
July 2012 • This is a “proposed rule” (no actual regulations have been amended/promulgated yet). The proposed rule is due for publishing via FR next week. • Stakeholders will have 120 days to lodge comments/concerns with FDA before FDA initiates the “final rule” stage. • All devices [201(h) of the Act] will require UDI except: […]
FDA to implement or reach a major milestone this year (2011) for forty-two of its prior fifty-five 510(k)-process recommendations
January 2011 In August 2010, FDA released for public comment a two-volume set of documents entitled “[CDRH] Preliminary Internal Evaluations,” which is comprised of the preliminary reports of two internal committees: The 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. Volume I is entitled “510(k) Working Group […]
Health Canada authorizes e-labeling for certain medical devices not sold to the general public
November 2010 On November 9, Health Canada’s Therapeutic Products Directorate (TPD) issued a permissive notice immediately authorizing device manufacturers of certain categories of devices to provide, in electronic format instead of paper format, the information ordinarily found in the directions for use pursuant to Section 21(1)(i) of the Canadian Medical Devices Regulations. The permissive notice […]
Health Canada gaining ground, but still backlogged in device license application processing
October 2010 In its September 7 interview with Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau), ComplianceAcuity confirmed that the Bureau is still wrestling with a significant increase in the volume and complexity of device license applications during the last 12-18 months. As the Bureau grapples with the influx, […]
Industry has until October 4th to comment on FDA’s 510(k) recommendations released July 30th
August 2010 The Food and Drug Administration’s (FDA’s) premarket notification (510(k)) process for the review of medical devices was established in 1976 and provides a more abbreviated mechanism of medical device premarket clearance than FDA’s Premarket Approval (PMA) process. As indicated by FDA, the 510(k) program, as it currently exists, aims to support FDA’s public […]
Health Canada decides to delay full STED implementation until July 1, 2011 for non-in vitro diagnostic Class III and IV Medical Devices
June 2010 As ComplianceAcuity previously reported in August 2009, Health Canada’s Medical Devices Bureau issued a notice proposing to fully implement the use of the GHTF STED format for Class III and IV premarket Medical Device License Applications by July 1, 2010. On June 17th, Health Canada announced that the full STED implementation will be […]
Health Canada backlogged in processing of device license applications
February 2010 In its February 25 interview with Sarah Chandler (A/Head, Regulatory and Scientific Section, Device Licensing Services Division, Medical Devices Bureau), ComplianceAcuity confirmed that the Bureau has seen a significant increase in the volume and complexity of device license applications during the last 12-18 months. As the Bureau grapples with the influx, the processing […]