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Industry got two wins in Tuesday’s bipartisan budget deal, which recommends the repeal of the 2.3 percent medical device excise tax and removes the threat of sequestration hanging over fiscal 2014 and 2015 FDA user fees. Read More
The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. 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
The International Medical Device Regulators Forum adopted four final guidance documents and two new work items relating to the Medical Device Single Audit Program during a meeting in Brussels last month. Read More
The FDA has created a new Division of International Compliance Operations to oversee inspections of foreign devicemakers and the international audit program. 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of the policies the Centers for Medicare and Medicaid Services (CMS) may get rid of under a new procedure for dropping outdated National Coverage Determinations (NCDs).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
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
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
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