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- FDA issues updated guidance on the regulation of digital health technologies
FDA issues updated guidance on the regulation of digital health technologies
November 25, 2019, Westlaw Journal Medical Devices
January 2020
Covington has created a list of Top 10 Questions for Ideation of Digital Health Solutions that can help lawyers contribute to the digital health ideation process. Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. "Ideation" is part of that process and involves the rapid ...
October 8, 2019, Covington Digital Health
On September 26, 2019, the FDA issued two revised guidance documents addressing its evolving approach to the regulation of digital health technologies. These guidances primarily describe when digital health solutions will or will not be actively regulated by FDA as a medical device. In parallel, FDA also updated four previously final guidance documents to ...
2019, American Bar Association
Our cross-disciplinary Internet of Things initiative contributed to the ABA's first book on IoT, The Internet of Things: Legal Issues, Policy, & Practical Strategies. Laura Kim and Jennifer Johnson authored the chapter “U.S. Regulatory Framework for IoT,” with contributions from Sarah Wilson (product safety); Wade Ackerman, Elizabeth Guo, Christopher Hanson, ...