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FDAnews Device Daily Bulletin
July 2, 2012 | Vol. 9 No. 129
Report: PIP Case Highlights MHRA’s Need for More, Better Medical Device Data
While judging the Medicines and Healthcare products Regulatory Agency’s (MHRA) response to the PIP silicone breast implant scandal basically sound, a new review by the UK Department of Health (DOH) finds the agency needs better access to information on devices to preclude similar safety scares in the future. The MHRA “fulfilled its obligations” in pursuing French devicemaker Poly Implant Prosthese about incidents involving its product and sought to determine the cause and extent of the problems being reported, the review states.
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