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The coalition urged the FDA to “explicitly state in the draft guidance that the CDER program applies to the device constituents of combination products under CDER jurisdiction.” Read More
The standard is applicable to any medical imaging equipment servicing organization, regardless of its size or the specific equipment maintenance services it provides. Read More
Russia signed an agreement with Brazil, Argentina and Mexico to share best practices and information on quality, efficacy and safety of medical products as well as adverse event information, on the first day of the International Medical Device Regulators Forum held in Moscow, March 19-21. Read More