U.S. Food and Drug Administration05.31.18
As part of the agency’s ongoing commitment to address the epidemic of opioid misuse and abuse, the U.S. Food and Drug Administration today 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.
Despite recent advances in some of these areas, there are still many opportunities to advance new technologies and bring new products to market to meet this urgent public health need. This challenge will provide those companies that are selected by the FDA under this new program with the opportunity to work closely with the agency to accelerate the development and review of their innovative products. The goal 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.
“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction,” said FDA Commissioner Scott Gottlieb, M.D. “For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids. This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction. We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis.”
The agency is encouraging developers to submit proposals. 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.
This new challenge 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 FDA will accept submissions from June 1, 2018, through Sept. 30, 2018, and intends to announce the selected applicants in November 2018. Submissions will be evaluated by a team from the FDA’s Center for Devices and Radiological Health based on the product’s feasibility, potential public health impact, and novelty of the concept.
Developers 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. In most cases, the agency anticipates that applicants will eventually submit one or more formal applications to the FDA, such as an investigational device exemption, De Novo, premarket clearance (510(k)) or premarket approval application.
“This new effort builds on the success of previous work to take a collaborative approach to promoting medical device innovation and safety, such as the 2012 challenge that led to multiple new approaches to treat life-threatening, end-stage renal disease,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder. We also hope that in turn these novel products may also help pave the way for the development of future products that build on the latest technologies.”
In the past few years, the FDA has cleared, granted, or approved more than 200 devices related to the treatment or management of pain, including 10 with new or novel technologies, such as brain and spinal cord stimulators that can relieve pain and reduce the need to administer opioid drugs to patients suffering from either acute or chronic pain. The FDA also recently granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal.
This innovation challenge is part of the FDA’s ongoing work to reduce the scope of the opioid crisis and supports several overarching goals of the U.S. Department of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis. The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioid products. The FDA will also continue to evaluate how drugs currently on the market are used, in both medical and illicit settings, and take action where needed.
Despite recent advances in some of these areas, there are still many opportunities to advance new technologies and bring new products to market to meet this urgent public health need. This challenge will provide those companies that are selected by the FDA under this new program with the opportunity to work closely with the agency to accelerate the development and review of their innovative products. The goal 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.
“Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction,” said FDA Commissioner Scott Gottlieb, M.D. “For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids. This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction. We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis.”
The agency is encouraging developers to submit proposals. 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.
This new challenge 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 FDA will accept submissions from June 1, 2018, through Sept. 30, 2018, and intends to announce the selected applicants in November 2018. Submissions will be evaluated by a team from the FDA’s Center for Devices and Radiological Health based on the product’s feasibility, potential public health impact, and novelty of the concept.
Developers 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. In most cases, the agency anticipates that applicants will eventually submit one or more formal applications to the FDA, such as an investigational device exemption, De Novo, premarket clearance (510(k)) or premarket approval application.
“This new effort builds on the success of previous work to take a collaborative approach to promoting medical device innovation and safety, such as the 2012 challenge that led to multiple new approaches to treat life-threatening, end-stage renal disease,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder. We also hope that in turn these novel products may also help pave the way for the development of future products that build on the latest technologies.”
In the past few years, the FDA has cleared, granted, or approved more than 200 devices related to the treatment or management of pain, including 10 with new or novel technologies, such as brain and spinal cord stimulators that can relieve pain and reduce the need to administer opioid drugs to patients suffering from either acute or chronic pain. The FDA also recently granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal.
This innovation challenge is part of the FDA’s ongoing work to reduce the scope of the opioid crisis and supports several overarching goals of the U.S. Department of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis. The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioid products. The FDA will also continue to evaluate how drugs currently on the market are used, in both medical and illicit settings, and take action where needed.
