Proposed 510(k) Changes Released
FDA has released its proposed changes to the 510(k) process for clearing medical devices. The 25-point action plan for 2011 includes: streamlining the review process for certain innovative, lower-risk medical devices; clarifying when clinical data should be submitted in a premarket submission; and establishing a new Center Science Council of senior FDA experts to aid in making decisions. The proposed changes are designed to promote device innovation and protect patient safety. See the full list of changes online.
Clearance for Siemens's D-Dimer Test to Exclude Deep Vein Thrombosis
Siemens Healthcare Diagnostics has received FDA clearance for its INNOVANCE D-Dimer blood test to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients where a physician’s pretest probability assessment (PTP) indicates a non-high probability of embolism. The fully automated test operates on the company's Sysmex and BCS family of coagulation systems.
FDA Issues Guidance for MRSA Tests
FDA has created a new list of recommendations for how nucleic acid-based in vitro diagnostic tests for Staphylococcus aureus (SA) should perform and be tested for their analytical and clinical validity. The document was designed to provide industry and agency staff with guidance for tests that detect and differentiate methicillin-resistant Staphylococcus aureus (MRSA) and SA. Such tests are used to prevent and manage infections in healthcare settings. FDA’s guidance document reflects the agency’s current thinking on MRSA tests. The agency stresses that the document should be viewed as recommendations that are suggested, but not required. See the full list of recommendations online.
AdvanDx's Test for Gram-negative Bloodstream Infections Cleared
Nanosphere's Respiratory Virus Subtyping Test Panel Cleared
diaDexus Receives Clearance for New Automated PLAC Test
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