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An Australian appeals court has supported Myriad Genetics’ ability to patent genes associated with breast-cancer risk, diverging from last year’s U.S. Supreme Court ruling, which declared the patents invalid. Read More
CDRH is readying its review staff to deal with the additional workload of laboratory-assisted tests, according to a center official who says talks are underway with third-party reviewers to help out. Read More
The FDA plans to implement unique device identification requirements over several years, “and we fully expect and intend to be flexible during that time,” an agency source says. Read More
The D.C. federal court on Tuesday again blasted the FDA for acting arbitrarily in deciding whether a combination product should be regulated as a device or a drug. Read More
As notified bodies in the EU conduct the first wave of unannounced quality audits of devicemakers, they are building profiles of the companies to determine when and how often they are inspected in the future. Read More
The FDA is pushing ahead with a proposal to regulate laboratory-developed tests, with CDRH chief Jeffrey Shuren showing no signs of backing down despite grilling from congressional skeptics during a Tuesday hearing. Read More
The Brazilian government is proposing major reforms to its public-private Product Development Partnership program, doubling the allowable length of PDP agreements from five to 10 years and establishing a committee to approve the projects. Read More
The device industry is asking the FDA not to impose controls, including quality system regulations, on manufacturers of low-risk health information management software that doesn’t serve a clinical function. Read More
St. Jude Medical said that it has resolved good manufacturing practice issues that had plagued its Plano, Texas, neuromodulation facility, leading to a 2009 warning letter. Read More