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The agency has authority to exempt class II devices from requiring 510(k) submissions if it can determine that a 510(k) clearance is not necessary to assure their safety and effectiveness. Read More
Foundation Medicine’s F1CDx can detect mutations in as much as 324 genes and two genomic signatures by sequencing DNA in solid tumor samples in a single test. Read More
The FDA released final recommendations for manufacturers of x-ray imaging devices aimed at clarifying the premarket review process and encouraging pediatric indications. Read More