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Amendment to Drugs and Medical Devices Law in Japan Takes Effect
Laurie A. Clarke,Colleen Heisey,Scott T. Jones,Mark Mansour,Mitsutaka Okano, December 16, 2014
A material amendment to the law regulating drugs and medical devices in Japan has recently been implemented. The amendment mainly covers (i) establishing a fast-track authorization process for regenerative medicine products (described below), (ii) restructuring medical device regulations, and (iii)...
FDA Voices Privacy Concerns and Promotes Medical Device Cybersecurity with New Guidance, Collaborative Information-Sharing
Laurie A. Clarke,Alexis Slagle Gilroy,Colleen Heisey,Kevin D. Lyles,Mauricio F. Paez, December 16, 2014
Cybersecurity of medical devices poses unique challenges for industry and regulators, because of potential risks in device malfunction, disruption of medical care, and compromised patient data, as well as the challenge of balancing countervailing needs, such as patient safety and ensuring that...
FDA Releases Framework for Overseeing Laboratory Developed Tests
Laurie A. Clarke,Brigid C. DeCoursey,Colleen Heisey, October 16, 2014
On September 30, 2014, the U.S. Food and Drug Administration ("FDA") released the two draft guidance documents setting forth FDA's proposed framework for regulating Laboratory Developed Tests ("LDTs") as medical devices: (i) Draft Guidance for Industry, Food and Drug...