FDA 510(k) Testing
ARE Labs excels in regulatory FDA testing, crucial for validating air purifier efficacy and accelerating product market entry. Specializing in FDA 510(k) testing, we have a proven track record in assessing a wide range of devices. FDA 510(k) submissions are essential premarket tests to demonstrate that a new medical device is as safe and effective as an existing, legally marketed device. This comparison is mandated by Section 510(k) of the Federal Food, Drug, and Cosmetic Act, ensuring that new devices meet rigorous safety and effectiveness standards before being commercially distributed. Our expertise supports clients through the complex FDA approval process, ensuring their products comply with critical regulatory requirements.
EPA Testing
ARE Labs provides essential testing services to ensure compliance with EPA guidelines for sanitization devices and chemical disinfectants, including UV light disinfection devices and aerosolized chemical agents. These products are regulated by the EPA for their effectiveness against bioaerosols and surface organisms.
In 2024, the EPA is expected to introduce new guidelines for air purification devices, including air purifiers and HVAC systems. These guidelines will specify requirements for efficacy claims and disinfection performance. ARE Labs is actively monitoring these regulatory changes and will offer testing services for devices affected by the new guidelines once implemented.
ASHRAE and ISO Testing
ISO Test Methods: ISO test methods are standardized procedures from the International Organization for Standardization (ISO) that assess the properties and performance of materials, products, services, and systems. These methods are globally recognized, designed for consistent and reproducible results, applicable universally across testing scenarios and locations.
ASHRAE Testing Services: ASHRAE standards, set by the American Society of Heating, Refrigerating and Air-Conditioning Engineers, optimize building systems, energy efficiency, and indoor air quality. While not mandatory, standards like ASHRAE 241 for removal efficiency are crucial for validating device effectiveness and supporting marketing efforts. These standards are essential for manufacturers to demonstrate product efficacy and sustainability in the built environment.
ASTM Testing Services: ASTM standards are a set of globally recognized guidelines and procedures developed by ASTM International, formerly known as the American Society for Testing and Materials. These standards are designed to ensure the quality, safety, performance, and regulatory compliance of materials, products, systems, and services across a wide range of industries and sectors.