FDA Seeks To Speed Innovative Medical Device Reviews

The proposed Innovation Pathway would fast-track premarket evaluations for breakthrough healthcare technologies.

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In an effort to help the U.S. maintain its position as the world leader in medical device innovation, the U.S. Food and Drug Administration (FDA) has proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices.

Announced Feb. 8, the initiative is part of a broader effort underway in the FDA's Center for Devices and Radiological Health (CDRH) designed to encourage cutting-edge technologies among medical device manufacturers. The program also seeks to strengthen the nation's research infrastructure for developing innovative technologies and advancing quality regulatory science.

The FDA said it is working toward conducting premarket reviews of products in the Innovation Pathway within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications.

Jonathan Linkous, CEO of the American Telemedicine Association, told InformationWeek the new initiative can help companies in the telemedicine industry improve the process of bringing their products to market.

"The Innovation Pathway is potentially a significant move that can save time and money for companies anxious to make new and innovative telemedicine devices available to the healthcare industry and the public. It also can help startup companies and innovators in telemedicine to better understand and work with the FDA," Linkous said.

During a telephone briefing to discuss the new initiative, FDA commissioner Margaret Hamburg told reporters that the proposed Innovation Pathway has broad implications for how the FDA does business, and how the agency will continue to support important opportunities for innovation.

"This is a critical moment for innovation, for our agency, and for our nation. The pace of biomedical discovery continues to accelerate, and the stakes have never been higher," Hamburg said. "By the end of the decade a combination of trends, including international competition, will test America's role as the global leader of product in innovations and as a nation we have important choices to make about how we move forward."

The FDA plans to seek further public comment before the Pathway can be used more broadly, but has moved ahead with its first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program.

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The proposed Innovation Pathway program includes the following elements:

-- products in the program would have to be truly pioneering technologies with the potential of revolutionizing patient care or healthcare delivery;

-- selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment, and regulatory review; and

-- products would be assigned a case manager, their important scientific issues would be identified and addressed earlier in the development process, and they might be able to qualify for flexible clinical trial protocols.

Applications would be reviewed by the Center Science Council, a new oversight body currently being developed within CDRH comprised of senior managers and experienced scientists, who would facilitate this device development and evaluation process.

Enrollment in the Innovation Pathway program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and determine their appropriateness for marketing. As the FDA seeks to drive innovation, the agency has also proposed several actions including:

-- establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a product's development and clinical testing stages;

-- creating a publicly available core curriculum for medical device development and testing to train the next generation of innovators; and

-- using more device experience and data collected outside the United States.

In addition, CDRH intends to engage in formal horizon scanning -- monitoring medical literature and scientific funding in a systematic way to predict where technology is heading. CDRH will include public input in this process to prepare for and respond to transformative innovative technologies and scientific breakthroughs, FDA officials said.

In his remarks during the briefing with reporters, CDRH director Dr. Jeffrey Shuren said American medical devices should lead the world both in the area of innovation and product safety. Shuren also said last month's PricewaterhouseCoopers report that found emerging markets, led by China, India, and Brazil, pose a threat to America's lead in medical technology innovation, should be taken seriously.

"We won't remain the world's leader for long if we do not invest in innovative science and innovative oversight. To successfully achieve our mission to promote and protect the public health means to strike the right balance between innovation and safety," Shuren said. "We must assure that our oversight doesn't stifle innovation, but rather, encourages innovation while maintaining a commitment to safety and effectiveness upon which Americans rely, and that other countries follow."

FDA officials note that because of the transformative nature of the devices that would be eligible for this pathway, CDRH expects them to generally be used for either high-risk or novel products.

CDRH has set up a public docket to solicit public comment on the Innovation Initiative and will host a public meeting on the topic on March 15.

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