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FDA Publishes Draft Updated Guidance on Medical Device Cybersecurity
  • Reed Smith LLP
  • USA
  • November 16 2018

We celebrated National Cybersecurity Awareness Month a few weeks ago by bringing you the FDA’s newly published Medical Device Cybersecurity Regional


The Diagnostic Artificial Intelligence Speedbump Nobody’s Mentioning
  • Reed Smith LLP
  • USA
  • November 8 2018

The 21st Century Cures Act is noteworthy as the first legislative attempt at regulating artificial intelligence (“AI”) in the medical field. The Act


FDA Provides Relief to Medical Device Manufacturers Under UDI
  • Arent Fox LLP
  • USA
  • November 8 2018

The FDA has delayed the date on which it plans to enforce compliance with certain Unique Device Identification (UDI) requirements, prompting a


Redraft of 510(k) Third Party Review Program
  • Duane Morris LLP
  • USA
  • November 8 2018

Section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes


What Digital Health Innovators Should Know about the FDA Approval Process
  • Jones Day
  • USA
  • November 6 2018

Jones Day partner Ann Hollenbeck shares an informative conversation with associate Ian Pearson, who was a lead in the area of digital health at the U


FDA Overhauls Premarket Cybersecurity Guidance for Device Makers
  • Reed Smith LLP
  • USA
  • November 6 2018

On October 18, 2018, the Food and Drug Administration (“FDA”) released a draft update to its guidance on the “Content of Premarket Submissions for


Digital Health Updates in the 2019 Physician Fee Schedule (PFS) Rule
  • Crowell & Moring LLP
  • USA
  • November 6 2018

CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to


Department of Homeland Security and FDA Collaborate to Address Medical Device Cybersecurity
  • Hall Render Killian Heath & Lyman PC
  • USA
  • November 2 2018

On October 15, 2018, the National Protection and Programs Directorate (“NPPD”) of the U.S. Department of Homeland Security (“DHS”) and the U.S. Food


Consider Playing By This Book's Rules: FDA-MITRE Cybersecurity Guidance
  • Baker Sterchi Cowden & Rice LLC
  • USA
  • October 31 2018

As part of Cybersecurity Awareness Month, we continue our discussion about the FDA’s efforts to help prepare various entities to address


BakerHostetler FDA and Pharmacy Weekly Digest - October 29, 2018
  • Baker & Hostetler LLP
  • USA
  • October 29 2018

The Food and Drug Administration (FDA) announced that it is investigating a multistate outbreak of Salmonella enteritidis it believes is linked to