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FDA Moves Toward Considering Patient Experiences in Medical Device Reviews

May 19, 2015

The Food and Drug Administration (FDA) has long considered how to factor in the experiences of patients when making regulatory decisions about medical devices, and now the FDA is moving closer to incorporating patient input into the process of reviewing new device applications.

The Medical Device Innovation Consortium, a collaboration of the device industry, the FDA, and the National Institutes of Health, have released a draft framework for device makers as they collect patient-preference information and submit the data to the FDA when seeking device approvals, Roll Call reports. The draft calls for the FDA to incorporate patient input in its reviews of new device applications. The House Energy and Commerce Committee will consider this issue as it works on legislation called 21st Century Cures.

Patient preference information is not required for a device maker seeking FDA approval, but Ross Jaffe of the venture capital firm Versant Ventures, calls it an "enhancement" to a submission, according to Roll Call. There is a wide array of medical devices under FDA jurisdiction, ranging from equipment used by physicians and nurses in testing and treatments, to devices like insulin pumps and pacemakers worn on or implanted in the body.

The FDA issued guidance describing the patient-preference information the agency will consider on device applications. The new guidance builds on documents issued in 2012 clarifying that the FDA would consider data on risk tolerance and perceived benefits as long as the data was validated by the agency. Research on patient preference is a newly emerging area of regulatory science. The fundamental challenge lies in determining how to measure patients' preferences in "preference sensitive" decisions - those situations in which benefits do not clearly outweigh risks. The FDA says it can use patient-preference data in evaluating device applications and in designing trials, but the process is still challenging and unclear. Telba Irony, of the agency's Center for Devices and Radiological Health asked how much benefit the FDA would want to see. "If we don't approve the technology for the 40 percent [who are more risk tolerant], then nobody has access to it."

The framework catalogs quantitative methods device makers can use, but this is just a start, members of the consortium agree. "This is going to be fairly overwhelming to the industry," said Diana Salditt, a regulatory affairs adviser at device maker Medtronic. Salditt noted the need for education, "[P]eople will need to see and maybe even work though some case studies on how this will be applicable." Salditt said device makers "understand how to identify the attributes patients want," but "don't understand . . . how to weigh attributes and measure the trade-offs." But the industry said it welcomes the FDA's consideration of additional data.

John F.P. Bridges, a professor at the Johns Hopkins Bloomberg School of Public Health and a researcher into patient perspectives in medicine said he never thought "anyone would pay attention to our research," according to Roll Call. "Based on good science and justice, one day preference information will become ubiquitous," Bridges said.

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