Clinical Lab Impact
“Even though this has clearly been targeted to manufacturers of RUO and IUO products, it will have an impact on clinical laboratories and clinical laboratory operations,” David Mongillo, vp for policy and medical affairs with the American Clinical Laboratory Association (ACLA), told GEN. “In some cases, the only technologies and reagents available for very important clinical services are RUO/IUO. And if they weren’t available, it would have an impact on physicians ordering these tests and their patients.”
ACLA, which lists 45 members on its website, most of them diagnostics developers, is among groups that plan to submit feedback to the FDA during the 90-day comment period the agency has launched on its draft guidance titled “Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions.” The guidelines were released on June 1, and the deadline for comments is August 30.
Also planning to submit comments are the American Society of Hematologists, a professional society whose 15,705 members focus on the causes and treatment of blood disorders; and the Association for Molecular Pathology (AMP), which specializes in clinical molecular laboratory medicine and translational research based on molecular biology, genetics, and genomics
“The advent of ASRs (analyte-specific reagents) enabled laboratories to use commercial products for patient benefit that would otherwise not be available. However, some products necessary for laboratory tests are available only as RUOs. The FDA RUO guidance may affect availability of certain tests, which, in turn, may limit a healthcare provider’s ability to manage patient care,” Mary Steele Williams, AMP’s COO and director of scientific programs, told GEN.
Dr. Mansfield said it was unlikely the draft guidance would delay drug development, noting that it applies to devices and was written with the purpose of informing manufacturers how they should market RUO- and IUO-labeled products. “We do not intend to interrupt laboratory testing, but we hope that laboratories will encourage their suppliers to conform with regulations as soon as possible,” Dr. Mansfield remarked.
Also unlikely, she said, were clinical trial delays due to concerns about relabeling RUO and IUO products: “Most products will not require relabeling for use in clinical trials. The appropriate labeling for products in the clinical trial phase is ‘for investigational use,’ and this type of labeling typically requires only compliance with the investigational regulations.”