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FDA Issues Draft Guidance on Medical Device Cybersecurity
  • Cooley LLP
  • USA
  • February 8 2016

Recently, the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices”


Key Components of FDA’s Draft Guidance for Medical Device Cybersecurity
  • Montgomery McCracken Walker & Rhoads LLP
  • USA
  • February 8 2016

On January 22, 2016, FDA issued draft guidance to manufacturers regarding the postmarket management of cybersecurity vulnerabilities in medical


FDA Seeks Comment on Draft Guidance for Manufacture of Interoperable Medical Devices
  • Mayer Brown LLP
  • USA
  • February 5 2016

On January 26, 2016, the US Food and Drug Administration (FDA) issued draft guidance entitled Design Considerations and Pre-market Submission


Watch out for Cybersecurity Threats to IoT (Internet of Things) Medical Devices!
  • Gardere
  • USA
  • February 5 2016

The Food & Drug Administration (FDA) issued draft guidelines since all IoT "medical devices that use software and are connected to hospital and


FDA Recommends Medical Device Manufacturers Implement a Comprehensive Cybersecurity Risk Management Program in Accordance with NIST Standards
  • Epstein Becker Green
  • USA
  • February 2 2016

Medical devices increasingly contain software or connect to networks that may leave the devices vulnerable to cyber-attacks. The U.S. Food and Drug


FDA Issues Postmarket Cybersecurity Recommendations for Medical Devices
  • Reed Smith LLP
  • USA
  • February 2 2016

On January 22, 2016, the federal Food and Drug Administration ("FDA") issued a draft guidance outlining postmarket recommendations for medical device


FDA's expanding views on cybersecurity and medical devices: draft guidance on postmarket management of cybersecurity
  • Pepper Hamilton LLP
  • USA
  • February 2 2016

Medical device manufacturers need to consider cybersecurity controls in all aspects of the product development process, from conception through


FDA Releases Draft Guidance for Medical Device Cybersecurity
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • February 1 2016

It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have


FDA Offers New Recommendations for Interoperability of Connected Devices
  • Hogan Lovells
  • USA
  • February 1 2016

On January 26, 2016, the Food and Drug Administration ("FDA" or the "Agency") released a draft guidance document, Design Considerations and


Safety First: FDA Issues Draft Guidance for Manufacturers of Interoperable Medical Devices
  • Quarles & Brady LLP
  • USA
  • January 28 2016

The Food and Drug Administration (FDA) recently issued draft guidance on interoperable medical devices, entitled "Design Considerations and