Establishment of a biological Risk Evaluation Program to Meet FDA and Notified body REQUIREMENTS AND CURRENT EXPECTATIONS

摘要

Requirements and "recommendations" for establishing an acceptable biological risk associated with patient-contacting devices are identified in the ISO 10993 series of standards and FDA Memo G-95. This presentation will outline the steps the speaker took to implement biological safety evaluation programs for a large and small medical device companies and identify ways of addressing specific challenges faced when little information is available on a material. Examples of recent requests for additional information will be discussed, along with means of providing the required information.