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FDA Releases Draft Guidances on Medical Devices and Biomarkers

NEW YORK (GenomeWeb News) – 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.

FDA developed the draft guidance on the pre-market approval (PMA) applications to provide clarity for industry and agency reviewers about the factors it considers when making determinations about the risks and benefits of medical devices. The agency has opened a 90-day public comment period on the guidance, which it published on its website today.

FDA said that the recommendations in the guidance are aimed at improving the predictability, consistency, and transparency of the PMA process.

Within the guidance, the agency provides a worksheet to show how it makes risk-benefit decisions and provides examples to illustrate that process.

When it reviews PMAs for medical devices, FDA uses safety and effectiveness data that address the potential risks and benefits of the devices, as well as the severity of any potential harm, and of the diseases or conditions the products diagnose.

“Clinical data is the foundation for determining the safety and effectiveness of medical devices requiring FDA premarket approval,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“As medical devices grow increasingly complex, many factors impact our benefit-risk determinations, especially for PMA devices. This guidance aims to provide more clarity to manufacturers about what factors we consider when making an approval decision.”

For assessing potential benefits and measuring the effectiveness of devices, FDA looks at the types of benefits the devices offer, as well as the magnitude, probability, and the duration of the benefits.

For assessing the possible risks or harm these devices pose, FDA considers the number, severity, and types of device-related serious adverse events, as well as the non-serious adverse events and procedure-related or indirect harms. The agency also weighs the probability of a harmful event – the percent of the population that may experience one – as well as the chances that a diagnostic test may generate false-positive or false-negative results, and how that could result in unnecessary procedures or incorrect diagnoses.

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.

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