Material Compatibility

Staci15 Jun, 2023Health

Material Compatibility is the understanding of whether or not the different component materials in a combination product can negatively interact with each other and impact the performance or safety of the overall product. It is important to determine the material compatibility of combination product as device leachables may accelerate degradation of a drug product. Another part of medical device compatibility analysis is the effect of disinfectants, sterilization, and/or cleaning. Material compatibility studies will likely need to be performed as part of Premarket Application (PMA) and 510(k) testing.