NanoSafe Coatings today announced the initiative to establish a Master Device File (MDF) with the FDA to insure that Medical Device companies seeking anti-microbial coating protection for medical products can expedite the FDA 510(k) process. NanoSafe is an innovative leader with a patented technology that provides a non-leaching, permanent, non-super bug promoting coating that can be applied to metals, plastics and fabric that comprise medical devices. The MDF will provide the FDA with validation aspects of the NanoSafe technology in the areas of:
•Formulation
•Manufacturing
•Antimicrobial Mechanism of Action
•Demonstration of Permanent binding
•Assessments of toxicity and leachabls
•Biocompatibility
•Stability.
NanoSafe has developed a unique pilot program for companies to test the NanoSafe coating on medical devices called the NanoSafe CRADA, where-in a medical device or component can be sent for anti-microbial coating to the NanoSafe Contract Manufacturing facility and subsequently be tested for both bacterial and viral “killing” efficacy.
The CRADA also provides a Company with a Regulatory Assessment as to the viability and pathway required to combine the NanoSafe anti-microbial coating to a medical device and the testing pathways required under 510(k) guidelines.
This Assessment will provide the key parameters of potentail anti-microbial product claims, device classifications, and testing required for a successful 510(k) filing and approval by the FDA. It is well known that “Healthcare-associated infections (HAIs), many of which are caused by antibiotic-resistant bacteria, impact one in 25 patients in the United States each year. These preventable infections claim the lives of 75,000 people and cost the healthcare industry between $36 billion and $45 billion annually.”
NanoSafe provides a viable alternative to heavy-metal applications for anti-microbial protection on medical devices to combat the causes of HAIs and welcomes Companies to initiate Pilot Studies with NanoSafe™
Contact Information: Marvin A. Collin Executive Vice President Business Development NanoSafe Coatings macollin@comcast.net 617-680-9792
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