FDA Releases Draft Guidances on Medical Devices and Biomarkers

The Food and Drug Administration has issued two new guidances affecting genomic technologies and genetic testing, including one detailing its policies for making risk-based assessments of medical devices, and another covering the process for the submission of genomic biomarkers for qualification by regulatory authorities.

The guidance on biomarkers includes recommendations covering the types of information that should be submitted in applications for qualification, which involves a judgment about whether a biomarker can be relied upon to reflect a biological process, response, or event. It is aimed at addressing genomic, proteomic, and imaging-based biomarker categories. The guidance was developed by the Efficacy Working Group of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The objective of the effort is to create a harmonized structure for qualification that will foster consistency across regions and would be recommended for use across ICH’s regulatory regions. The guidelines are general, according to FDA, and the data formatting for a qualifying biomarker may vary significantly.

According to the guidance, the biomarker qualification submissions should include sections containing regional administrative information, and summary information covering the proposed context of use, data description, critical appraisal of the methods and data supporting the applications. These summaries could include analytical assay data, as well as nonclinical and clinical biomarker data.

The guidance also provides recommendations for how to provide quality reports, and clinical and nonclinical reports about assay development and validation and clinical pharmacology and efficacy reports.