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Lawmakers call for changes in approval process for medical devices

Washington, DC - U.S. Senator Amy Klobuchar announced last week that she has sent a bipartisan, bicameral letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg regarding concerns over the agency's approval process for medical devices.

Every year, medical devices are estimated to contribute $25 billion to the nation's economy, and are responsible for over 420,000 jobs. The United States has always been a leader in medical technology, but today many devices are debuting in Europe months or years before they are on the U.S. market, Klobuchar said. Approval times for medical devices have slowed dramatically, while poor communication and a lack of transparency have complicated the process, she said.

Klobuchar is co-chair of the Congressional Technology Caucus, whose members joined her on the letter, including U.S. Senator Al Franken and U.S. Representative Erik Paulsen.

In the letter, Klobuchar and the Caucus members state: "Today, the United States accounts for 40 percent of the global medical technology market and the industry indirectly creates two million American jobs. Maintaining American leadership in this field is essential for jobs and for patients. Unless we make significant improvements to the predictability and transparency of the regulatory process, we will lose the industry, the jobs that go with it, and the innovation to transform our healthcare system."

In the letter, the Klobuchar and the Caucus call for several changes to the FDA approval process, including:

· Recognizing and correcting the disparity between "FDA time" versus real time when tracking device approvals

· Considering potential benefits of harmonization with international testing standards

· Addressing the unintended consequences of the conflict of interest rules for advisory panels

· Creating a transparent tracking and review system for applications and clearance decisions

Problems at the FDA were included in a report from the President's Job Council, which stated: "Today, however, our medical innovation ecosystem is in jeopardy. Investment in the life sciences area is declining at an alarming rate because of the escalating cost, time and risk of developing new drugs and devices. While many factors have contributed to this decline - including challenges around reimbursement and the general state of the economy - an important factor is the uncertain FDA regulatory environment. These concerns come at a time when Europe, China, and India continue to entice companies to take their medical research and development enterprises abroad, putting at risk our ability to keep private investment and jobs here at home."