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FDA Clarifies 510(k) Pathway for Bio-Gate’s Silver Antimicrobial Coating

Update: This article was updated March 19 to further clarify FDA's comments. 

Based on FDA feedback during a pre-submission process, Bio-Gate announced its HyProtect™ coating technology that protects against implant bacterial colonization can undergo the 510(k) pathway without human data for certain orthopaedic products depending on type and duration of patient contact, exposure levels and regulatory precedent.

HyProtect is an ultra-thin plasma coating made of pure silver and polysiloxane. According to Bio-Gate’s website, HyProtect also exhibits no cytotoxicity, high biocompatibility, and can be adapted to different materials (including all metals, polymers, and more) and gamma sterilized.

Currently, there is no such coating available in the U.S. market. Bio-Gate’s is in the process of commercialization and is in collaboration with device companies to bring HyProtect to the U.S. and European markets.

Located in Nuremberg, Germany, Bio-Gate is ISO 13485 Certified. Its subsidiary, QualityLabs BT, is an ISO 17025 Certified laboratory for biological and chemical testing.

Source: Bio-Gate AG