The FDA has issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
If the agency's proposed reclassification is finalized, devices of this type may go through the 510(k) pathway for clearance instead of the premarket approval (PMA) pathway.
Four companies unite to form Discovery Life Sciences.
Now is the time to make sure that hospital executives are fully educated about details of the Protecting Access to Medicare Act of 2014.
Read MoreLaboratories that meet CMS criteria must collect their private payor data for the first half of 2019, and report it to CMS no later than March 31, 2020.
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The federal law comes with significant cuts to Medicare testing fees, but labs that take steps now will be better able to meet the challenge.
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The renewal applies to specialties that include clinical chemistry, diagnostic immunology, hematology, immunohematology, and microbiology.
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The agency’s exemption would apply only to cytometry instruments used for counting or characterizing cells.
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The emergency diagnostics taskforce will help to prepare the agencies to respond during public health emergencies.
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VisualStrata is a precision medicine informatics platform that uniquely integrates diagnostic, clinical, and financial data to support value-based care initiatives.
Read MoreOrtho Clinical Diagnostics has announced an international distribution and copromotion agreement with Thermo Fisher Scientific, to provide 14 assays for use in monitoring therapeutic drugs, immunosuppressive drugs, and drugs of abuse.
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Congenica has received certification to ISO 13485:2016, the quality management systems standard for medical device manufacturing, which supports comprehensive policies and processes across the entire business.
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The American Association of Bioanalysts has filed in support of the American Clinical Laboratory Association lawsuit challenging the Medicare fee schedule implemented in January under the Protecting Access to Medicare Act (PAMA).
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The tool can help clients assess whether they are in compliance with HIPAA’s security, privacy, and breach notification requirements.
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The $1.5 million award is intended to support and expand the efforts of government agencies to instill quality practices and recommendations at CLIA certificate of waiver sites.
Read MoreClinical labs should ensure that the components they use in developing and performing laboratory-developed tests are themselves consistent in quality and other attributes necessary to produce an accurate report.
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According to FDA, today’s laboratory-developed tests are frequently manufactured using components and instruments that are not legally marketed for clinical use, and often rely on high-technology instrumentation and software to generate results and clinical interpretations.
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Shifting interpretations of the CLIA guidelines will allow clinical laboratories to develop alternative quality control policies, replacing equivalent quality control procedures, as of January 1, 2016. Rose Mary Casados, president of COLA Resources Inc, outlines the steps involved in establishing an Individualized Quality Control Plan.
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