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The American Clinical Laboratory Association and American Medical Association are promising an all-out fight to stop the FDA from requiring premarket applications for high-risk laboratory-developed tests. Read More
Device and diagnostics makers would have to submit all clinical trial data to the federal government — including data for products never approved by the FDA — under a massive, proposed expansion of data collection. Read More
The FDA is seeking a court order to force a retired dentist in South Dakota to pull the laser devices he manufacturers from the market, but the defendant maintains he has the right to sell the devices through a private membership association. Read More
Manufacturers of low- and moderate-risk devices will soon be able to register their products in Australia based on conformity certificates issued by European notified bodies, under a government action plan unveiled Oct. 14. Read More
Software to help diabetics manage their condition has advanced significantly in recent years, but gaps in regulation and interoperability issues are hindering access, industry and patient groups told the FDA Thursday. Read More
The European Commission is again seeking input on the risks associated with di(2-ethylhexyl) phthalate plasticized PVC in medical devices, saying more data is needed before banning its use. Read More
Devicemakers may use alternative approaches to dual boot designs in new submissions for molecular diagnostic tools that combine approved and unregulated functions if they demonstrate that the nonregulated functions don’t interfere with the approved ones, FDA final guidance says. Read More
A sweeping rewrite of Canada’s drug safety law that authorizes the government to order recalls and require labeling changes and postmarket studies could spell new worries for devicemakers because it also allows for the release of confidential business information on unsafe products. Read More
The FDA plans to tighten restrictions on dozens of spinal screws already on the market, requiring new PMAs for dynamic stabilization systems that are used to treat severe spondylolisthesis, fracture, dislocation, scoliosis and spinal tumors. Read More