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  • Regulatory NewsRegulatory News

    Wound dressing firm warned for design, environmental control issues

    An Ohio firm that is both an own-label distributor and specification developer of sterile wound dressings received a warning letter from the US Food and Drug Administration (FDA) for ongoing problems including a lack of medical device reporting procedures, design control issues, and lack of document and environmental control, among others.   CellEra LLC, which distributes wound dressings with drugs such as silver, petrolatum and collagen, received the 20 October warnin...
  • CDRH Cedes Regulatory Authority for Certain Wound Care Products to CBER

    If you're the sponsor of a wound care product, you may soon be dealing with a new set of regulatory staff at the US Food and Drug Administration (FDA), the agency announced in the Federal Register on Tuesday. The 13 August 2013 announcement explains that FDA is "transferring oversight responsibilities for certain wound care products" from the Center for Devices and Radiological Health (CDRH), where some new reside, to the Center for Biologics Evaluation and Research (C...