May 30, 2018

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has launched a new program to fast-track development and market authorization of devices for treating opioid addiction and pain management.
  • Manufacturers have  until September 30, 2018 to submit applications to participate in the program.
  • Accepted manufacturers’ devices and technologies will undergo expedited premarket review.

US FDA innovation challenge for medical devices targeting opioid addictionMedical device regulators at the US Food and Drug Administration have initiated a new campaign to support development and commercialization of novel devices aimed at pain treatment and opioid addiction.

Under the FDA’s new “Innovation Challenge,” the agency will accept applications from June 1 to September 30, 2018 from manufacturers whose devices target prevention and/or treatment of opioid use disorder, which now poses a major health crisis across the US. The program is open both to companies developing new devices and technologies as well as manufacturers of devices already marketed in the US that can demonstrate that their products provide better benefit-risk profiles than opioids for pain management.

Criteria for program submissions

Open to both conventional medical devices as well as mobile medical applications and digital health technologies, the program requires applicants to provide information including:

  • Novelty of the device or technology
  • Product development plan
  • Development team components
  • Expected benefits of the device for patients and public health compared to available alternatives

Applicants should also be prepared to address feasibility of FDA collaboration and expedited premarket review of their devices.

How the program will work for selected manufacturers

For applicants accepted into the program, the FDA’s Center for Devices and Radiological Health (CDRH) will collaborate with them to expedite development and clearance or approval of devices. Applicants will eventually submit 510(k), Premarket Approval (PMA), De Novo or Investigational Device Exemption (IDE) applications to FDA for expedited review.

CDRH collaboration will begin after qualifying applicants have been notified of their acceptance into the program. The collaboration phase will include establishing a mutual understanding of the device and how it addresses opioid addiction and pain management, followed by identifying the most appropriate regulatory pathway for commercialization.

Following the September 30, 2018 submission deadline, FDA will announce accepted applicants in November 2018.

Related US FDA medical device regulatory information:

  • US FDA 510(k) consulting for medical device and IVD companies
  • US FDA Pre-Sub (Q-Sub) consulting for medical devices
  • Whitepaper: FDA regulations for novel and innovative medical devices