Simplifying Global Compliance
A group of patients is asking for sanctions against Johnson & Johnson’s Ethicon unit following allegations the company destroyed thousands of documents related to ongoing pelvic mesh trials. Read More
If some lawmakers get their way, the federal budget proposal for fiscal 2014 and 2015 now being negotiated will include a provision shielding FDA user fee revenue from any across-the-board sequestration cuts. Read More
Devicemakers testing the Wi-Fi functionality of their products should simulate the radio frequency (RF) characteristics of a hospital and should use access points from different manufacturers, a recent white paper from Laird Technologies recommends. Read More
Devicemakers that operate in Brazil should be checking to see that none of their business holdings has been charged with corrupt practices — either in Brazil or elsewhere in the world, experts warned during a recent American Bar Association meeting devoted to the country’s new antibribery law. Read More
HeartWare’s $30 million purchase of a circulatory system support device company makes smart financial sense for the company, analysts say. Read More
An FDA review of Mectra Labs’ website found that the company was offering a new size of its MAGI and ALIEN insufflation needles without clearance or approval, prompting a warning letter. Read More
Kiwi devicemakers are crying foul over proposed fee structures for the Australia New Zealand Therapeutic Products Agency (ANZTPA), saying they will stifle innovation among smaller medtech companies and limit access to new technologies. Read More
The Centers for Medicare & Medicaid Services’ (CMS) final rule on the end-stage renal disease prospective payment system (PPS) assuages some industry concerns about the 2014 payments for ESRD facilities, an attorney says. Read More
Synecco, a China-based contract manufacturer and contract sterilizer, received an FDA warning letter for shortfalls in sterilization validation and other GMP issues. Read More
National coverage policies on laser procedures and Xenon scans are among 10 of the policies the Centers for Medicare and Medicaid Services (CMS) may get rid of under a new procedure for dropping outdated National Coverage Determinations (NCDs). Read More
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 – Fax (703) 538-7676 – Toll free (888) 838-5578.
Copyright ©2013. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing