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FDA CDRH: New Organizational Structure Effective May 1, 2019

In the fall of 2018, the U.S. Food & Drug Administration’s (FDA) Center for Medical Devices and Radiological Health (CDRH) announced the largest reorganization in years to initiate the Total Product Life Cycle (TPLC) approach across the institution (read more here). Fast forward to May 1, 2019—the date that the CDRH declared that it had … Continued

FDA Shifts 510(K) Paradigm, Announces Transformative Steps to Modernize 510(k) Program

Since May 28, 1976, the United States (U.S.) Food & Drug Administration (FDA) has had an alternative in place to the extremely burdensome Investigational Device Exemption (IDE) and Pre-Market Approval (PMA) processes to get new products onto the market, and that alternative is called the 510(k) process. By definition, “510(k) merely refers to the relevant … Continued

FDA CDRH Reorganization: Faster Reviews for Medical Device Manufacturers?

The U.S. Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is currently undergoing one of its most ambitious reorganizations in decades to initiate the Total Product Life Cycle (TPLC) approach across the organization. The TPLC methodology, which has been in place in the Office of In-vitro Diagnostics and Radiological Health (OIR) … Continued

The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy

Introduction Medical device manufacturers have at their fingertips many types of clinical studies to demonstrate product safety and efficacy, one of which is a randomized, controlled pivotal trial. While there are many routes to initiate these types of trials, sponsors requiring such studies would be wise to first consider conducting a small randomized pilot study … Continued