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  • Blog: Homeostasis: Dykema Health Care Law BlogWinning with FDA: How to Manage a Successful 510(k) Device SubmissionPosted on July 22, 2021 by M. Mark Mansour
    In order to secure approval of a medical device, a sponsor must use one of several pathways prescribed by the FDA. The primary avenues are the 510(k) clearance, the Pre-Market Approval (PMA) and the de novo submission. This post will focus on the most common pathway, the 510(k). Virtually all Class II medical devices are cleared via the 510(k) submission process. While the 510(k) process is the least complicated, sponsors sometimes find it obscure and difficult to navigate. We will explore the most effective strategies for securing a 510(k) clearance, with a focus on the needs of smaller compa...
  • Blog: Ireland IP & Technology Law BlogEDPB provides guidance on requirements of data processing contractsPosted on July 16, 2021 by Davinia Brennan
    The finalised EDPB Guidelines on the concepts of controller and processor (07/2020) in the GDPR were published this week. The Guidelines set out the EDPB’s recommendations on what should be included in data processing contracts between controllers and processors, in order to ensure compliance with Article 28 GDPR. We have set out some key highlights...Continue Reading…
  • Blog: Waller Law BlogExecutive order targets hospital consolidation, non-competesPosted on July 8, 2021 by
    Executive order aims to increase scrutiny on healthcare mergers, limit non-competes and support price transparency.
  • Blog: Biologics BlogFederal Circuit Upholds Jury Award, Weighs in on Willfulness Standard, in Adynovate® DisputePosted on March 29, 2021 by
    According to the Federal Circuit, $173 million was the right damages award for almost three years of patent infringement resulting from Baxalta’s sale of its biologic product Adynovate® (Antihemophilic Factor (Recombinant), PEGylated).  In Bayer Healthcare LLC v. Baxalta Inc., et al., Nos. 2019-2418, 2020-1017 (Fed. Cir. 2021), the circuit court upheld an award to Bayer [...]

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