When extracts of a medical device are required for a biocompatibility test protocol, a current practice is to follow the guidance in ISO 10993 Biological evaluation of medical devices–Part 12: Sample ...

However, that costs time and money, and the document looks the same as the one on the FDA Web site. Due to the lack of easily obtainable information, an engineer or regulatory affairs officer may ...

Plastics possess many unique properties, can be used to make many different products and are highly manufacturable. These properties are being increasingly exploited in the production of medical ...

The US Food and Drug Administration (FDA) has published a chemical dataset that analytical laboratories can use to demonstrate they can detect chemicals that may not be biocompatible for use in ...