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    FDA making changes in approval processes for industry, patients


    Device trial changes

    Device approvals are often compared to a moving target, but approval for minimally invasive glaucoma surgery (MIGS) devices is clearer than before. The agency issued a final guidance on Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices in December 2015. The guidance grew out of a joint FDA-American Glaucoma Society workshop in early 2014.

    “There was a lack of definition of devices and patient populations and there were no clear safety targets or endpoints for safety and effectiveness in clinical trials,” said Malvina Eydelman, MD, director of the division of Ophthalmic Device Evaluation. “While we were seeing quite a rapid increase in submissions for MIGS, there was a lack of recognized standards that would clearly delineate safety and efficacy endpoints. We ended up having substantial discussions with each of the individual sponsors.”

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    The new guidance delineates key clinical and nonclinical recommendations for MIGS developers. But it does not address one of the hottest topics inside the FDA–patient preferences. Device designers and makers, as well as clinicians, must bring patients into the decision-making process.

    “Patient views about the most important benefits and most acceptable risks for MIGS devices may differ considerably from those of health care professionals,” Dr. Eydelman said. “We feel the patient perspective is imperative to incorporate into the next step of MIGS evolution.”

    Saying that “patients are the heart of what we do at FDA,” Dr. Eydelman noted that patient preferences have come to inform the development and assessment of medical progress.

    The FDA Center for Devices and Radiological Health created a patient preference initiative to develop a systematic approach to assessing, measuring, and incorporating patient preference through the product life cycle, she continued. The agency’s first-ever patient preference draft guidelines were published in May.

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    The agency also launched collaborations with Johns Hopkins University School of Medicine to assess patient preferences in glaucoma treatment with a focus on MIGS devices and with Stanford University to develop a patient-reported outcomes measure, assessing quality of life in mild-to-moderate glaucoma patients.

    “We believe that the patient perspective should inform medical device development during the total life cycle of the device,” Dr. Eydelman said. “Starting with discovery, patient information is needed. (Patient involvement) will proceed to development of prototype, preclinical, and clinical assessment. Once we look at safety and effectiveness data, patient preference should be part of the benefit-risk assessment.”

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