Regulatory News

FDA Accepts Three Companies for Innovation Pathway Approval Process

April 11, 2012

The fast-track approval program is a desirable prize for company applicants.

In February, the U.S. Food and Drug Administration (FDA) introduced an initiative initially called the Innovation Pathway. The FDA has just announced that it has approved three new devices for the special fast-track pre-market approval (PMA) process, which takes approximately half the time (150 days) it would for a full-length review, if all goes according to plan. The program is now called Innovation Pathway 2.0.

Out of the 32 applications the FDA received, the following three were accepted:

• An implantable renal assist device being developed by the University of California, San Francisco.
• A wearable artificial kidney in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.
• A hemoaccess valve system that has been designed by Greenville, S.C.-based CreatiVasc Medical.

The Innovation Pathway program was designed to encourage cutting-edge technology development among medical device manufacturers.
“The response from innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction,” said Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health (CDRH).

The FDA’s CDRH has developed the Center Science Council, which is responsible for the review of applicants to the program and also for facilitating the development and review process. The council is made up of senior managers and scientists. The approved applicants will be assigned a case manager to guide them through the approval process, and will bring in outside experts as needed to help with regulatory and scientific obstacles.

The approved devices all treat end-stage renal disease. Since kidneys are necessary to remove waste from the body, kidney failure means certain death. Kidney failure also is indicative of general organ failure. Besides encouraging innovation, the FDA’s fast track program also will speed the application to PMA process of life-saving devices and treatments.

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