Drug Delivery Silicones – Additional Regulatory Information
NuSil maintains an unsurpassed level of regulatory support for its products. We understand that meeting the needs of a demanding regulatory environment is critical to the current supply and future of drug delivery device and material developments. NuSil routinely communicates with the U.S. FDA and other global regulatory bodies and is willing to support its materials for long-term implantable and drug delivery applications.
Our Unrestricted Drug Delivery Silicone materials feature the following regulatory support:
- Documentation
- Drug Master Files (DMFs) submitted to U.S. FDA
- USP Class VI and applicable ISO 10993 Testing Support
- Testing guided by European Pharmacopeia, Monograph 3.1.9
- Highlighted Per-Lot Testing
- Select ISO 14949 testing – including hexane reflux extraction
- FT-IR Spectroscopy (Evaluated on each part of the system)
- Unique lot numbers assigned to each uncured part
- Tissue Culture (Cytotoxicity Testing) or select Toxicity testing