4 June 2018 - - Silver Spring, Maryland-based public health protection provider US Food and Drug Administration (FDA) has launched an innovation challenge to spur the development of medical devices, including digital health technologies and diagnostic tests, that could provide novel solutions to detecting, treating, and preventing addiction, addressing diversion, and treating pain, the agency said.
This innovation challenge is part of the FDA's ongoing work to reduce the scope of the opioid crisis and is open to products in any stage of development, from concept to testing. The challenge also is open to developers of currently marketed devices who are interested in demonstrating that their device has an improved benefit-risk profile as compared to opioids in the management of pain.
The goal of the challenge is to provide additional incentives for product developers to invest in products that can address aspects of the addiction crisis, and advance the development of promising technologies.
These could include products such as diagnostics to identify patients at increased risk for addiction, treatments for pain that eliminate the need for opioid analgesics (such as opioid-sparing or replacement therapies for acute or chronic pain), treatments for opioid use disorder or symptoms of opioid withdrawal, as well as devices or technologies that can prevent diversion of prescription opioids.
Developers are asked to submit proposals between the dates of June 1, 2018, through Sept. 30, 2018 and those accepted into the challenge will receive enhanced interactions with FDA review divisions during the development and evaluation of the proposed product.
In addition, breakthrough device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application.
The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.