Devices & Diagnostics

Medical device leaders take to D.C. to push FDA reform

The medical device industry is stepping up the pressure on Congress in its call for a more consistent regulatory environment at the FDA. The Advanced Medical Technology Association, or AdvaMed, flew 20 medical device CEO’s into Washington to “urge Congress to help preserve the industry’s competitiveness and global leadership in the development of new medical […]

The medical device industry is stepping up the pressure on Congress in its call for a more consistent regulatory environment at the FDA.

The Advanced Medical Technology Association, or AdvaMed, flew 20 medical device CEO’s into Washington to “urge Congress to help preserve the industry’s competitiveness and global leadership in the development of new medical devices and diagnostics.”

The “fly-in,” as the industry council calls it, is part of the association’s roll-out of its “competitiveness agenda,” which it released two weeks ago. The agenda recommends six policy initiatives, including trade, tax, payment, regulatory and research policies that ask government to make innovation in the life sciences a top priority. In addition, the trade council is asking the White House for a special government office with oversight of “major proposed and current government policies to assure that they support medical innovation.”

One of the lynch pins of the council’s agenda is reforming the FDA review process to reduce review times and changing payment policies at Medicare and Medicaid to support medical innovation.

When it released its agenda, the industry council didn’t mince words when it came to the FDA, saying that the increasing decision times at the watchdog agency have “a devastating impact on the competitiveness of the American medical device industry, as well as on patients.”

AdvaMed called for the agency to measure its metrics on total review time, rather than “FDA days” in measuring its time to approve medical devices for market. The agency currently only measures days that the product is under review by reviewers when reporting metrics to Congress under the medical device user fee agreement.

“Part of the problem is that FDA manages to the wrong metrics,” AdvaMed officials wrote. “What matters to industry and to patients is not time on the FDA clock, it is the total time from the time the product is submitted to FDA for review to the time it is cleared for market. Accordingly, FDA must set a goal of reducing total review times.”

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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