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FDA draft guidance on mobile apps signals increased regulatory oversight

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 27 2011

On July 20, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance identifying the mobile device applications“apps”the agency plans to regulate as medical devices

FDA shift on diagnostics lays groundwork for regulation of lab-developed tests global life sciences - U.S. FDA update

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 15 2011

On July 12, 2011, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) announced plans to down-classify and exempt from Section 510(k) premarket notification a range of in vitro diagnostic and radiology device types

New FDA draft guidance holds IVD manufacturers responsible for clinical use of ROUIUO products

  • Sidley Austin LLP
  • -
  • USA
  • -
  • June 16 2011

In a new proposed guidance, FDA has signaled its intention to shift responsibility for the use of certain medical devices from customers to manufacturers, based on an expansive and legally questionable presumption of “intent.”

U.S. Food and Drug Administration and European Medicines Agency enter into new good clinical practices collaboration

  • Sidley Austin LLP
  • -
  • European Union, USA
  • -
  • August 5 2009

On August 3, 2009, the U.S. Food and Drug Administration (FDA) announced a collaborative agreement with the European Medicines Agency (EMEA) for a Good Clinical Practices (GCP) Initiative