Medical Foam Articles & Analysis
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Silicone manufacturers supplying material to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly or through the US FDA Master File program. 1. Scope 1.1 This guide is intended to educate potential users of silicone ...
4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications. Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary product formulation to their ...