AcuFocus Receives Approvable Letter From FDA for IC-8 Small Aperture IOL
AcuFocus announced receipt of an Approvable Letter from the FDA for its IC-8 small aperture IOL. The letter indicates the FDA has completed its review of the IC-8 IOL premarket approval (PMA) application and determined that the PMA substantially meets the requirements of the Food Drug and Cosmetic Act, and the FDA believes it can approve the application following successful completion of the pre-approval inspections at the company’s manufacturing facilities in the U.S. and internationally.
In March of 2020, the FDA announced foreign facility inspections would be postponed due to the COVID-19 pandemic.1 As a result of the current environment, AcuFocus anticipated a delay in the preapproval manufacturing inspections of its international manufacturing facility.
“We are thrilled to receive the approvable letter from the FDA ahead of our MDUFA date and we look forward to working with the FDA to successfully complete these customary pre-approval inspections,” Al Waterhouse, president and CEO for AcuFocus, said in a company news release. “The AcuFocus team and our global partners have worked diligently to build a robust, quality management system to ensure that both the integrity of our supply chain and the quality of our devices are maintained.”
Commercialization of the IC-8 IOL in the US will begin upon successful completion of the manufacturing facility inspections and receipt of an official approval order from the FDA, which the company estimates in Q2 2022.
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