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Sat, May 17, 2025

CDRH

Home » Topics » Regulatory » CDRH
  • Regulatory us fda hq
    May 1, 2025
    By Mark McCarty

    FDA’s Tarver says agency open to improvement of third-party reviews

    Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), covered several programmatic areas in a May 1 trade association meeting, such as the CDRH early alert program.
  • 12 8 dexcom g7 cgm
    March 26, 2025
    By Mark McCarty

    FDA says changes in Dexcom G6, G7 sensors constitute misbranding

    The U.S. FDA’s March 4, 2025, warning letter to Dexcom Inc. is a well-detailed but heavily redacted document explaining the agency’s misgivings about procedures such as monitoring of acetaminophen content in glucose test dishes.
  • Regulatory recall
    March 25, 2025
    By Mark McCarty

    Smith’s Medical removes endotracheal tubes due to small diameter

    The FDA reported March 25 that Smiths Medical Inc., is recalling a series of oral and nasal endotracheal tubes because the diameters of the tubes may present with “a smaller diameter than expected.”
Read More

Blog Posts

  • Nov. 25, 2014
    By Mark McCarty

    Thank you government!

  • Rns12
    March 8, 2013
    By Marie Powers

    Statistical tinkering in device regulation a disservice to patients

  • Sep. 27, 2012
    By Mark McCarty

    Bull in a China shop: Jeff Shuren at CDRH

  • Aug. 7, 2012
    By Mark McCarty

    FDA misconduct not deemed newsworthy

  • May 7, 2012
    By Mark McCarty

    The future of device regulations: the EU model or the FDA approach?

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