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FDA commits to moving forward with LDT regulation
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • November 24 2015

Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration's Center for Devices and Radiological Health, announced at a hearing

IEEE developing new standards for 3D printers for medical uses
  • Reed Smith LLP
  • USA
  • November 11 2015

The Institute of Electrical and Electronics Engineers Standards Association (IEEE) is developing new interoperability standards for medical devices

Top takeaways from 33rd Annual IAHA Annual Meeting
  • Thompson Coburn LLP
  • USA
  • November 9 2015

On Oct. 27, 2015, the Annual Meeting of the Illinois Association of Healthcare Attorneys was held at Navy Pier in Chicago. Hundreds of health care

New EMC guidance released by FDA
  • Hogan Lovells
  • USA
  • November 5 2015

On November 2, 2015, the Food and Drug Administration (FDA) released a draft guidance document, "Information to Support a Claim of Electromagnetic

FDA takes steps to clarify significant human tissue questions
  • Hogan Lovells
  • USA
  • November 4 2015

On October 30, 2015, the Food and Drug Administration (FDA) issued a draft guidance document, Homologous Use of Human Cells, Tissues, and Cellular

AdvaMed 2015 highlights part two of two
  • McGuireWoods LLP
  • USA
  • October 9 2015

This continues our coverage of the Advanced Medical Technology Association's ("AdvaMed's") 40th Annual Meeting held over October 5-7, 2015. For the

AdvaMed 2015 highlights part one of two
  • McGuireWoods LLP
  • USA
  • October 8 2015

On October 5-7, 2015, the Advanced Medical Technology Association ("AdvaMed") held its 40th Annual Meeting for the first time on the West Coast

DuPont's upgraded manufacturing process regarding their Tyvek material and impact on medical device manufacturers
  • Hogan Lovells
  • USA
  • October 5 2015

In an announcement issued by the Food and Drug Administration ("FDA" or the "agency") on October 2, 2015, the agency has determined that the

HHS issues proposed rule that would revise the Federal Policy for the Protection of Human Subjects
  • King & Spalding LLP
  • USA
  • September 28 2015

On September 8, 2015, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies collectively issued in the

Was it worth the wait? New proposed rule issued to update the “Common Rule”
  • Quarles & Brady LLP
  • USA
  • September 18 2015

On September 8, 2015, 16 federal departments and agencies issued a Notice of Proposed Rulemaking (NPRM) to revise the "Common Rule," a regulation