The U.S. Food and Drug Administration (FDA) has launched a new pilot program that aims to streamline medical device development, increase predictability and reduce the time from concept to commercialization.
The FDA has launched the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot, which intends to de-risk the medical device “valley of death” by providing the industry with more interactions and strategic input from stakeholders and the FDA’s Center for Devices and Radiological Health (CDRH).
The move comes after the Medical Device User Fee Amendment (MDUFA) V Agreement was signed into law Sept. 30, 2022. The FDA is taking a phased-enrollment approach to the program, starting with the TAP Pilot Soft Launch, which will be conducted in 2023, beginning Jan. 1. CDRH will enroll up to 15 devices in the Office of JHealth Technology 2 (OHT2): Office of Cardiovascular Devices.
The pilot also comes after the FDA leveraged emergency use authorization (EUA) to more quickly respond to the COVD-19 pandemic, including authorizing vaccines.
The pilot will build on lessons learned from the Breakthrough Devices and Early Feasibility Study programs and experiences with sponsors during the pre-EUA process as part of the COVID-19 pandemic response.
“Throughout the COVID-19 pandemic, we have seen the transformative impact of near and real-time interactions between developers and CDRH experts getting devices developed, evaluated, and authorized quickly,” the FDA stated. “However, that level of engagement requires specific and dedicated resources. CDRH has already begun recruiting the additional expertise needed at both the leadership and staffing levels to ensure the successful launch of the Pilot.”
The TAP Pilot will also establish a dedicated cadre of FDA advisors to provide feedback and advice tailored to the specific needs of each developer with a device in the program. This feedback can help developers improve their submissions, including having a better understanding of the FDA’s expectations when it comes to generating evidence to support submissions. The hope is that this proactive feedback will enable prompt identification of device issues that might delay the FDA’s authorization, giving developers the opportunity to address these issues earlier and have chances of faster authorization.
Following the soft launch, the FDA plans to expand the TAP Pilot to include a second OHT and enroll up to 45 devices in 2024, followed by another OHT and up to 65 enrolled devices in 2025. The program will first focus on CDRH-designated breakthrough devices that provide safer, more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."