For the past 30 plus years, the label “For Research Use Only” has been confusing to many medical and research professionals as well as marketing and sales personnel.
Additionally, these products remain unregulated without Food and Drug Administration (FDA) oversight. As the industry transitions into the age of molecular diagnostics to remain innovative with the pharmaceutical industry efforts to develop medical products for unmet medical needs, FDA regulatory oversight is need more than ever.
Although these products remain an important commercial class, a regulatory framework to regulate their development, manufacture and distribution for the appropriate laboratory intended use.
The topics for discussion in this webinar will be summarized to provide lists of dos and don’ts for marketing, sales personnel, manufacturers and research professionals to achieve their goals, remain compliant and to develop products that will be safe and effective for use in patients. An appropriate regulatory framework will promote innovation for those unmet medical needs instead of being an obstacle to it.
For medical professionals involved with clinical development of drugs and medical devices, they are well educated that the Food and Drug Administration (FDA) is the regulating agency that provides the regulatory requirements necessary for final approval.
Additionally, medical devices intended for clinical diagnostic use and the FDA also actively regulates diagnostic kits, which are intended for the same clinical use. In contrast however, Research Use Only (RUOs) products are unregulated. Research Use Only products are often discussed as medical devices but they are not devices but an important commercial class of products.