The following statement is attributed to Michael Petricone, senior vice president, government and regulatory affairs, Consumer Technology Association (CTA), regarding the Food and Drug Administration’s (FDA) recently released working model for the Software Precertification Program, Version 0.2:
“CTA supports the FDA’s Pre-Cert program which provides more streamlined and efficient regulatory oversight of software-based medical devices from companies who demonstrate a robust culture of quality and organizational excellence. Version 0.2 of the program builds on a strong foundation and will speed up the entry of new and vital medical technologies to market. CTA’s comments, with input from our Health and Fitness Technology Division – including Fitbit, Samsung, Philips, Google and others - applauds the administration’s efforts to enable an early engagement process, clarify the real-world performance data requirements and develop a risk-based framework. In addition to providing two levels of certification for organizations, Version 0.2 recognizes that underlying principles of the excellence appraisal need to be consistently interpreted and applied across the industry.
“As FDA itself has noted, the approach proposed for the new Pre-Cert program is well suited to the faster, iterative design, development and type of validation used for software as a medical device.
“CTA appreciates the FDA’s unprecedented willingness to encourage innovation. We believe this program will significantly improve healthcare outcomes for the benefit of patients and physicians alike. We look forward to continuing to work closely with the FDA as CTA members continue to deliver lifesaving health solutions.”
CTA’s comments filed today can be found here.