Intelligent Bio Solutions Receives Guidance From U.S. FDA On A Regulatory Pathway For Expansion Into The United States For Its Intelligent Fingerprinting Drug Screening Cartridge
Portfolio Pulse from Happy Mohamed
Intelligent Bio Solutions Inc. (NASDAQ:INBS) has received guidance from the U.S. FDA on the regulatory classification of its Intelligent Fingerprinting Drug Screening Cartridge. The FDA has provisionally determined that the cartridge falls within a Class II type device that requires the submission of a pre-market notification 510(k) and the FDA's clearance prior to marketing. This provides a clear regulatory pathway for INBS's expansion into the United States.
June 28, 2023 | 12:33 pm
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The FDA's guidance provides a clear regulatory pathway for INBS's expansion into the U.S. market. This could potentially increase the company's market share and revenues in the future.
The FDA's guidance is a crucial step for INBS's expansion into the U.S. market. With the FDA's clearance, the company can start marketing its drug screening cartridge in the U.S., potentially increasing its market share and revenues. However, the actual impact will depend on the market acceptance of the product and the company's execution of its expansion strategy.
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IMPORTANCE 80
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