Articles by Cynthia Schnedar

1. Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty? 10/27/2020

   The FDA has historically not initiated formal actions to enforce the statutory requirements to register and provide clinical trial data to the ClinicalTrials.gov data bank. However, industry is now on notice that the FDA is about to change its approach.

2. What Does IMDRF's New Cybersecurity Guidance Mean For You? 12/2/2019

   Principles and Practices for Medical Device Cybersecurity is intended to help facilitate international regulatory convergence on medical device cybersecurity by explaining fundamental concepts, best practices, and recommendations for all stakeholders.