Health Equity for Medical Devices: FDA Discussion

The Health Equity discussion with the regulated industry has been heavily weighted towards drugs and biologics. However, lack of diversity is an issue for medical device clinical trials as well. The FDA listed several considerations in its discussion paper this week on the topic aiming to collect feedback from the device industry and other stakeholders … Read more

What is FDA Acceptable Real World Evidence? 

There is a significant misunderstanding about what is acceptable Real World Evidence (RWE) to support market approval applications for regulated products by the FDA. Is published literature acceptable, or is it clinical experience with marketed products, what is the weight of patient-reported outcomes, or is it only data from medical records, and so on? Apparently, … Read more