R.P.Brown1, M.E.Stratmeyer1, L.A.Alonge2, P.J.Phillips3, 1Office of Surveillance and Biometrics, 2Office of Device Evaluation, CDRH, FDA, Rockville, MD 20852
Science-based regulation is an integral part of the Total Product Life Cycle (TPLC) process for medical devices. The use of a science-based approach to support regulatory decision-making and risk communication activities in CDRH is illustrated by the use of the results of the safety assessment of di-2-ethylhexyl phthalate (DEHP) released from polyvinyl chloride (PVC) medical devices to support the development of a public health notification and a draft guidance document. The CDRH Office of Science and Technology (OST) recently conducted a safety assessment of DEHP released from PVC devices (http://www.fda.gov/cdrh/ost/dehp-pvc.pdf and concluded that male neonates undergoing certain medical procedures represent a patient population at increased risk for developing adverse effects following exposure to DEHP-containing medical devices. Based on the results of the safety assessment, the CDRH Office of Surveillance and Biometrics (OSB) issued a Public Health Notification (http://www.fda.gov/cdrh/safety/dehp.html) providing guidance to health care providers on means to limit exposure of this patient population to DEHP. In addition, the CDRH Office of Device Evaluation (ODE) issued a draft guidance (http://www.fda.gov/cdrh/ode/guidance/1407.html) for the purpose of soliciting public comment on measures that manufacturers of DEHP-containing PVC devices can take to reduce patient exposure to DEHP. This process illustrates the successful interaction among CDRH Offices to address a public health issue.