Recently FDA Commissioner Scott Gottlieb released a statement on a record year for device innovation. This press release highlights the FDA’s efforts for advancement of medical devices that serve previously unmet medical need, improve quality of life, and in some cases save lives.
The FDA’s efforts to continue the advancement of device innovation was highlighted in 2018 by a record number of novel device approvals (106), surpassing previous years and the approval of nine breakthrough devices.
During 2018 the FDA released several statements outlining their efforts to ensure safety while fostering innovation with their modernized approach to device safety, and most recently their plans to further modernize the 510(k) clearance pathway. As a result of the recent changes to modernize the 510(k) program the FDA recently released another guidance outlining an alternative to the 510(k) pathway with a focus on improved safety and performance of new products.
FDA Commissioner Scott Gottlieb emphasized that the FDA is committed to improving patient safety and fostering innovation in the coming year. This commitment includes the continued development of the National Evaluation System for Health Technology (NEST). NEST is a collaborative national evaluation system being built by the FDA to capture data throughout the lifecycle of medical devices. The aim is to improve the quality of information available for healthcare providers and patients to make more informed decisions, while making the medical device evaluation process more efficient.
The FDA also expects to release a plan for the “Safer Technologies Program (STeP)”. This program will further analyze how the standards of the Breakthrough Device Program can be applied to improved products aimed to treat or diagnose non-life-threatening diseases and conditions.
As the FDA continues to improve safety and greater innovation; Scott Gottlieb recognizes that it’s essential for the FDA to not only stay ahead of the product advancements to come but be willing to embrace and lead change.
What are your thoughts on the current plans to improve patient safety and foster medical device innovation?