Pearls of Wisdom
FDA takes new steps to update digital health plan and empower consumers
On Thursday, July 27th the US Food and Drug Administration released details on its plans for regulating digital health technologies. Additionally, FDA shared information about its upcoming pilot program to pre-certify software-based medical devices. In...
How FDA listens to the voice of patients
The Food and Drug Administration (FDA) vows to never forget that their efforts to evaluate and approve new medical products is done to benefit patients. Because of this they are constantly looking to find new ways to incorporate the views and expertise of...
Changes to medical device consensus standard recognition requests
The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) detailed changes to its process for handling requests for the agency to recognize new voluntary consensus standards for medical devices. CDRH announced the changes...
M&A, Private Equity investments in CROs skyrocket
According to Business Insider, “Wall Street is interested in the companies that help drug makers research and develop drugs.”1 Those companies are also known as contract research organizations (CROs) and are becoming increasingly important for the...
List of 1,003 Class II device types exempt from 510(k) requirements finalized by FDA
Monday, July 10th, the US Food and Drug Administration (FDA) finalized a list of 1,003 types of class II medical devices that do not present risks requiring premarket notification review to provide assurance of safety and effectiveness. The list was created under the...