FDA Announces Quicker New Medical Device Approval Program

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The Food and Drug Administration has announced a new Innovation Pathway program to make the process of approval of medical technologies quicker.

This week, the agency announced the new program to expedite the approval of ground breaking new medical technologies. Under the Innovation Pathway program, technologies that have the potential to revolutionize medical care will be quickly identified and the approval process will be expedited.

According to the agency, the new program will reduce the amount of time it takes to approve medical technology by half. However, agency officials have been quick to assure the public and California pharmaceutical injury lawyers that all safety considerations will still be met before the approval process is complete.

There are several conditions that medical technology companies must meet before their medical products can be approved under the Innovation Pathway process. For one, the product must be a pioneering technology that has the potential to revolutionize patient and medical care, not just enhance it. Once a product is identified, the company will receive the Innovation Pathway memorandum from the agency’s Center for Devices and Radiological Health. The memorandum will contain a timeline for the development of the device. After that, a case manager will be assigned to identify the important scientific issues associated with the medical technology.

The first product to be considered under the program is the world’s first robotic upper extremity prosthetic. The Defense Advanced Research Projects Agency has submitted a device that is designed to restore natural-like arm, hands and finger function to patients who suffer from spinal cord injury. The device has been in development by the Pentagon, at the cost of more than $100 million.

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