The Digital Life

In a recent blog post, FDA Commissioner Scott Gottlieb reinforced FDA’s plans for supporting the growing innovation in medical technology.  Dr. Gottlieb reemphasized the support for digital medical technologies through the implementation of the 21st Century Cures Act, which requires FDA to clearly define those technologies that are used for the promotion of health life choices and generally exempt from, or left to, FDA’s regulatory discretion.  In coming months, FDA will be releasing further guidance to clarify where multiple function software applications fall under regulatory and compliance enforcement and where they do not.  In an even more progressive approach, FDA will be considering third-party certification to release low-risk devices to the market without clearance and higher risk devices with a streamlined clearance process in hopes to reduce time to market and the cost of innovation.  Finally, FDA is allying itself with the National Evaluation System for Health Technology (NEST).  NEST gathers post-market data from multiple sources, including registries, electronic health records, and payer systems.  The hope is that the post-market data could provide real world evidence to support new technologies or increase the functionality of existing technologies.  Streamlining the process to bring these technologies to market will be certain to promote innovation.  Regardless of the pathway to market or the level of compliance oversight, these devices will still be required to be safe and effective.  The most certain way to ensure this is through management of an established quality system, designed to function at a level commensurate with the risk of the technology.  For more information on the future of medical device technology, see our whitepaper, “Don’t Wait! Keeping Up with Medical Device Compliance”.