Glossary Term
Critical Path Initiative (CPI)
Definition
The Critical Path Initiative (CPI) is an FDA-led effort aimed at modernizing the development, evaluation, and approval processes for medical products, including drugs, biologics, and medical devices. The initiative focuses on fostering innovation, improving regulatory science, and addressing inefficiencies in the product development pipeline to accelerate the delivery of safe and effective medical technologies to patients.
Relevance to the MedTech Industry
CPI is designed to enhance the scientific tools, methods, and standards used in medical device and product development. By improving the predictability and efficiency of regulatory pathways, CPI helps MedTech companies bring innovative solutions to market faster, ultimately benefiting patient care.
Additional Information & Related Terms
Regulatory Science A key focus of CPI, involving the development of tools and methods to improve regulatory processes.
Real-World Evidence (RWE) Supported by CPI to enhance post-market surveillance and clinical evaluation.
Adaptive Clinical Trials An innovative trial design promoted by CPI to improve trial efficiency.
FDA The lead organization driving the Critical Path Initiative.