Written By: Narek Hakobyan
In the space of medical and scientific research, correctly labeling your product is more than mere semantics – it's a vital regulatory step. At Mercury, we understand that when it comes to Research Use Only (RUO) labels, the choice isn't just about words; it's about ensuring compliance with regulatory standards and the ethical use of your products in research settings, including their safe and efficient shipping. In this blog, we'll explore the intricacies of labeling and shipping RUO products for research use.
RUO, or Research Use Only, denotes products intended exclusively for scientific research, distinct from diagnostic, biological, therapeutic, or commercial applications. These products span various scientific disciplines, encompassing life sciences, medical research, chemistry, physics, and materials science.
The FDA's definition of RUO products, since 2013, classifies them as In Vitro Diagnostic (IVD) products in the laboratory research phase, exempt from part 812 regulations. This category includes tests, instruments, software, and reagents. Grasping the regulatory perspective is crucial as mislabeling can result in legal consequences affecting both the product and its shipping processes.
Guidance from regulatory bodies plays a pivotal role in comprehending and adhering to RUO labeling. It strongly emphasizes precise labeling, especially for RUO and Investigational Use Only (IUO) IVDs, to prevent misuse during transportation and utilization.
Shipping RUO labeled products for research involves best practices and considerations:
When it comes to RUO labeled research products, the journey goes beyond transportation. It revolves around safeguarding the integrity, purpose, and compliance of your products, ensuring they reach the research destination intact. While precision is pivotal in this field, knowledgeable guidance is equally essential. Mercury is here to assist you in navigating the intricacies of RUO labeling and shipping, so your products can safely and compliantly reach their destination.