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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
The FDA is finalizing guidance that urges sponsors to minimize device design changes in generic drug delivery products, and outlines how differences could threaten substitutability. Read More
The company said the approval “forms the basis of the additional regulatory approval it will seek through the World Health Organization prequalification program.” Read More