Corning Incorporated (NYSE: GLW) announced today that two of its products – Corning® Med-X® Glass and Corning® Med-Gamma® Glass – are now registered as compliant with U.S. Food and Drug Administration (FDA) regulations. This compliance demonstrates Corning’s commitment to supporting public health, safety, and security through high-quality radiation-shielding glass.
“With this registration, Corning becomes the first radiation-shielding glass manufacturer on the market to provide its customers and their end-customers with full compliance and traceability adhering to FDA requirements,” said Pierre-Jean Baron, general manager, Corning Specialty Glass.
Corning is a world leader in radiation shielding glass solutions for medical, nuclear, and industrial applications. In partnership with strategic distributors, equipment manufacturers, and shielding specialists around the world, Corning developed a comprehensive radiation shielding range with global production capabilities to complement its innovative glass solutions portfolio.
As per U.S. regulations, Corning registered with the FDA for Corning® Med-X® Glass and Corning® Med-Gamma® Glass under the classification of Radiology devices / Personnel protective shield. These two glass product categories are used as Class I medical devices as defined by the FDA.
The FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective and safer. It is also responsible for helping the public get the accurate, science-based information they need to use medical products and foods. Corning is engaging with the FDA on multiple fronts including streamlining adoption of Corning Valor® Glass, the company’s new, revolutionary pharmaceutical glass packaging.
