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:
“Since the announcement of the Digital Health Innovation Action Plan, CTA has supported the administration’s efforts to develop a precertification (Pre-Cert) program for medical device software. This program will speed the introduction of new and vital medical technology by providing qualified companies with a more streamlined pre-market review process. This simplified approach is well suited to the fast, iterative design and validation used for medical device software.
“We appreciate the administration’s willingness to embrace innovation, take a less-burdensome regulatory approach and focus oversight on higher risk areas. We believe this program will significantly improve healthcare outcomes for the benefit of patients and physicians alike. We look forward to working closely with the FDA as CTA members continue to deliver even more cutting-edge and lifesaving medical solutions.”
CTA’s comments filed today can be found here.