Senate approves FDA's 'breakthrough pathway' for medical devices

Senate approves FDA's 'breakthrough pathway' for medical devices

by Gail Kalinoski, Contributing Reporter | March 23, 2016
Business Affairs Medical Devices Population Health

The National Center for Health Research also claimed that smaller clinical trials could compromise the majority of patients because they may have “fewer women, people of color and patients over 65 – often too few to ensure that the device is safe and effective for those groups.”

But senators who supported the legislation, like Sen. Orrin Hatch, R-Utah, have emphasized the potential for saving lives by getting innovative new products to patients sooner.

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“We’re giving more patients a fighting chance to improve their lives,” Hatch, one of the sponsors of the breakthrough products bill, said according to Fortune.

Fortune noted that the senators had to finally resort to some good old-fashioned compromise to move the bills along. Democrats, except for Sen. Elizabeth Warren, D-Massachusetts, agreed to back them after money was added to the medical research budget at the National Institutes of Health. The Republican senators agreed to limit the number of devices that could get the “breakthrough” designation, according to Fortune.

Warren voted against the bills, and several others that were part of the legislative packet on drug and device issues, because she wants to see mandatory funding for the NIH and FDA, according to Bloomberg BNA.

But HELP Committee Chairman Lamar Alexander, R-Tennessee, called the bills important because they can affect nearly all Americans.

“Everybody wants to take advantage of this remarkable scientific opportunity of biomedical research,” he stated, according to Bloomberg.

Lamar said the committee will likely take up more bills in early April to get ready for appropriations hearings that begin in mid-April.

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