The three main steps in developing a Biological Safety Evaluation (BSE) are 1) Biological Evaluation Plan (BEP), 2) Perform Testing and Written Risk Assessments, and 3) Biological Evaluation Report (BER). A BEP is developed based on risk of the device to the patient. With this in mind, several factors need to be considered to ensure that unnecessary testing is avoided. A useful testing plan will address the device as a whole, starting with materials and processes and ending with patient exposure (type and duration).
An understanding of testing options is crucial as the approach to determining the safety of a device is moving away from check box based decisions to scientific justification for when testing is necessary and when it is not. This will include a discussion about changes in the regulatory world that include an important use for chemistry testing.
As BSEs become more complex, a summary report is essential to draw the right conclusions from the data submitted to support the overall safety of a medical device. A written assessment is requested in ISO 10993-1 as well as in the FDA guidance document. We will go over the information needed and the important points that should be included in the report.
This webinar will also include discussion of how to assess biocompatibility of device and process changes. Composed of a 50 minute presentation followed by a Q&A session, the webinar will cover the broad scope of developing a BSE. This webinar will be based on ISO 10993-1 and the FDA Guidance document on ISO 10093-1 (effective September 2016).