FDA Approval of Xenex Device: Regulatory Shift for Whole Room UV
Changes in the infection control marketplace are governed by three crucial factors: technological innovation, consumer trends, and regulatory measures.
Recently, the U.S. Food and Drug Administration (FDA) made a significant regulatory change by granting Xenex De Novo authorization for their LightStrike+ device.
Formal authorization of the Xenex device established a new medical device product classification, making the LightStrike+ robot the first and only product of its kind.
The FDA’s decision to authorize Xenex’s LightStrike+ robot has major regulatory implications for UV companies marketing similar devices to hospitals, including paving the way for companies to utilize the streamlined 510(k) approval process.
Testing destined for submission to FDA for pre-market approval of medical devices must be conducted in compliance with FDA GLP regulations, found in 21 CFR Part 58. As a Good Laboratory Practice (GLP) facility, Microchem is well-positioned to provide comprehensive testing services to UV companies seeking compliance with these new regulatory trends.
Partnering with a reputable laboratory like Microchem is essential for any company aiming to ensure the efficacy and safety of its products. Contact our lab today to learn more or discuss your UV testing project. Ramm at [email protected].