MIAMI—“We all recognize that innovation has an instrumental role in medical progress, and we [at the FDA] acknowledge that there are real problems with the landscape of medical device innovation in the U.S., the biggest of which is outsourcing,” said Andrew Farb, MD, senior reviewer at the Office of Device Evaluation at the FDA's Division of Cardiovascular Devices. But, he also added that “I’m from the government, and we’re here to help.”
Early clinical testing has largely moved outside the U.S., which is problematic for American patients, explained Farb during an Oct. 22 presentation at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference.
To counteract this trend, “there is a climate of change at the FDA. We recognize that there are human costs associated with delaying access to new technologies in the context of limitations of current treatment alternatives,” he added. “The climate of change also allows for a shift from protecting public health to promoting public health.”
As part of this re-evaluation, the FDA is working on new initiatives, including the Innovation Pathway launched in 2011, and several new guidance documents.
The Innovation Pathway is aimed at pioneering new technologies that address unmet clinical needs where there are no clinical treatment alternatives. Innovation Pathway allows sponsors and FDA staff to jumpstart discussions and collaboration early in the process “to identify appropriate and least burdensome steps to move the process forward,” said Farb. “This close, consistent collaboration also seeks to identify ways in which the technology can move from concept to market in a quicker period of time.”
Innovation Pathway was partly born from frustrations expressed by sponsors about personnel turnover among the FDA review staff, which led to inefficiencies as well as the need for renewed education efforts. “There is turnover for the sponsors as well,” Farb pointed out.
Therefore, through Innovation Pathway, the FDA made attempts to improve documentation to address any inconsistencies that may result from turnover, and sought to improve the quality of submissions. “These two changes allow for new staff to review the documents and not cause too much lag time,” Farb said.
In general, the agency has been trying to appropriately reduce the amount of time for the pre-market review process, without risking safety of the patient. “If we have a robust post-market structure in the U.S., then less information may be required in the pre-market side,” he added.
Also, there are two guidance documents—one in draft form and one finalized.
The finalized guidance addresses benefit and risk and has regulators consider the totality of the vendor whose device is being profiled, the limitations of currently available therapies and the patient population and disease state.
The Early Feasibility guidance, which is being written, is intended to facilitate the clinical evaluation of medical devices in the U.S., early in their development, using risk mitigation strategies. “These studies will involve a small number of subjects of a device intended for a specific indication before the device has been fully developed to provide initial safety data,” said Farb.
Important to this process is the amount of data—either clinical or nonclinical—that the sponsor initially brings to the table, he stressed.
However, this process is not meant to be in a silo. The vision of this Device Evaluation Strategy, as laid out by Farb, is that it will be part of a living document to be updated, and so varied device regulatory processes can inform each other.
“Medical device innovation has obvious public health benefits,” he concluded. “The solution lies in getting the answer quicker, and not just getting to market in a shorter period of time.”