Earlier this year, FDA sent a challenge to the medical device industry: develop devices and diagnostics to help combat, prevent, and treat the opioid crisis.
FDA said the challenge demonstrates its commitment to an “all-of-the-above approach to more forcefully confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of opioid addiction.”
The agency held a webinar to detail how medical device developers could be a part of the solution.
“In the past few years, the FDA has cleared, granted, or approved more than 200 devices related to the treatment or management of pain,” said Michelle Tarver, MD, PhD, director, patient science and engagement program, Office of the Center Director, CDRH. “This includes 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. She noted that FDA also recently granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal.
“With these many existing devices, the FDA remains committed to encouraging innovation both in the diagnosis and treatment of chronic pain as well as opioid use disorder. That brings us to the CDRH Innovation Challenge,” she said.
“We want to encourage development of non-opioid treatments for both acute and chronic pain,” said Jonathan Jarow, MD, chief medical officer, Office of Device Evaluation, CDRH. “And we want to expedite both the development and review of innovative, safe, and effective medical devices that either help prevent or treat opioid use disorder.”
Products eligible for the challenge include any medical device that prevents or treats opioid use disorder. Jarow said this would include diagnostic devices, therapeutic devices, digital health technology — such as mobile medical apps — and combination products as long as the primary mode of action is by the device.
“Medical devices at any stage of development are eligible,” said Jarow. “Applicants can be either U.S.-based or foreign, but when a foreign applicant applies, they have to recognize that foreign firms need a U.S. representative to market a medical device in the United States.”
If your application is selected for the Innovation Challenge, Jarow said there will be an initial development phase where there will be a lot of interactions between the CDRH review staff and the device developer, which will culminate — hopefully — in a premarket application. The device will receive expedited review. Jarow encouraged applicants to submit multiple applications if they have more than one eligible device.
Applications must be submitted electronically to FDA by September 30, 2018. Those selected for the challenge will be announced in November.
Editor and Director of Medical Content