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FDA Publishes Long-Awaited Draft Guidance on 510(k) Requirements for Modified Devices
  • McDermott Will & Emery
  • USA
  • August 10 2016

On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff

HHS Office for Civil Rights Updates Its Website with Guidance on HIPAA Audits and Unique Device Identifiers (UDIs)
  • Sidley Austin LLP
  • USA
  • August 4 2016

HHS-OCR has updated its website with guidance on two important and current issues: ongoing HIPAA audits and deidentification. After officially

FDA issues final guidance for general wellness devices
  • Morgan Lewis
  • USA
  • August 1 2016

On July 29, the US Food and Drug Administration (FDA) announced the availability of its guidance document, General Wellness: Policy for Low Risk

2016 Rocky Mountain IP Conference: The PTAB Speaks
  • Holland & Knight LLP
  • USA
  • July 26 2016

I attended the 14th annual Rocky Mountain IP & Technology Institute at the beginning of June. An interesting addition to this year's Institute was

FDA’s new Next Generation Sequencing Draft Guidance leaves fundamental questions unanswered: key points
  • DLA Piper
  • USA
  • July 26 2016

The Food and Drug Administration has released a 25-page Draft Guidance document addressing FDA oversight of certain applications of Next Generation

Medical Device Alert - The European Commission published a revised MEDDEV on the classification of stand alone software as medical device
  • Hogan Lovells
  • USA
  • July 18 2016

On 15 July 2016, the European Commission issued a revised version of MEDDEV 2.16 entitled “Guidelines on the qualification and classification of

Commission publishes further TTIP documents in ongoing transparency commitment
  • Baker McKenzie
  • USA, European Union
  • July 18 2016

On 14 July 2016, the European Commission published a record number of EU proposals from the ongoing 14th round of talks for a trade agreement with

Second Draft of the EU mHealth Guidance: “Better Use of Better Apps for Better Healthcare”
  • Arnold & Porter Kaye Scholer LLP
  • European Union
  • June 23 2016

At the eHealth Week conference last week, the European Commission presented the latest draft of the EU guidelines on the assessment of mHealth apps

FDA draft guidance offers recommendations on how to ensure proper dissemination by manufacturers of patient-specific information derived from medical devices
  • Loeb & Loeb LLP
  • USA
  • June 12 2016

The document clarifies that medical device manufacturers may share patient-specific data from a medical device with the patient using that specific

FDA Releases New Draft Guidance Document on 3D Printing of Medical Devices
  • Hogan Lovells
  • USA
  • May 19 2016

Additive Manufacturing (AM), commonly known as 3D printing, is increasingly being used in the manufacture of medical devices, including orthopedic