Silicone elastomers for medical use: A practical guide to compliance

Medical devices are classified by the level of controls necessary for patient safety in 21 CFR 860. Materials used in a medical device must be evaluated for biocompatibility and biodurability. The ISO, USP and ASTM write standards for the evaluation of medical materials and are recognized by consensus by the FDA. The course of biological evaluations required for a specific application can be found by considering the nature of body contact and duration in ISO 10993 and USP Monographs and . From these standards, the specific test protocols can be used to qualify materials for medical use. The ongoing quality control testing may only require limited testing such as cell culture (in-vitro) to release new batches for use. In this manner, animal welfare is taken into account and human safety remains paramount. Both manufacturers and fabricators of silicone elastomers for medical use have a great number of considerations in pursuit of medical compliance. The circle of compliance is made when the FDA adopts biocompatibility standards, used by material suppliers to provide screened products for medical use, selected by fabricators for the application and process, where premarket notification is submitted by the OEM back to the FDA, who provides premarket approval by FDA 510(k) authority.