The opioid epidemic is one of the most profound public health crises facing the United States and the current crisis of opioid overdose deaths requires innovative approaches. The FDA remains committed to addressing this national crisis on all fronts, with a focus on encouraging medical product innovation to prevent new cases of opioid abuse and addiction and to treat those addicted. The agency has already taken significant steps to decrease public exposure to opioids, prevent new cases of opioid use disorder—also known as opioid addiction—and support the treatment of those with the disorder. As part of important efforts to address the epidemic of opioid misuse and abuse, the FDA is launching an innovation challenge to spur the development of medical devices, including diagnostic tests and digital health technologies (mobile medical applications) to help combat the opioid crisis and achieve the goal of preventing and treating opioid use disorder.
CDRH will accept applications for the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder (“the Challenge”) from June 1, 2018, through September 30, 2018. Medical devices that lead to the prevention and treatment of opioid use disorder are desired and their developers are encouraged to apply. 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, may also apply. Applicants selected for the Challenge will work directly with the FDA to accelerate the development of and eventual review of marketing applications for innovative products, similar to what occurs under the Breakthrough Devices Program. In addition, Breakthrough Device designation will be granted to those devices that meet the statutory criteria for designation without submission of a separate application. Proposals submitted will be evaluated based on the feasibility, potential public health impact, and novelty of the concept. The number of proposals selected into the Challenge will be determined by the quality of applications received and available FDA resources. The FDA intends to announce applications selected for the Challenge in November 2018.
Opioid use disorder is a serious health condition that can cause significant physical, emotional, and cognitive impairment. The disorder can arise as an unintended consequence of routine medical care, abuse of prescription opioid pain medications and the use of illicit opioid drugs. Opioid use disorder affects more than 2 million Americans1, disproportionately impacts minority populations, and is increasing among people ages 45 to 64. Through this Challenge, the FDA aims to promote and expedite the development of innovative medical devices to help prevent opioid use disorder from happening at all.
Basic Criteria for Challenge Submissions
The Challenge is intended for diagnostic or therapeutic medical devices, including mobile medical apps, that address the opioid epidemic by preventing and treating opioid use disorder (opioid addiction). Potential examples of medical devices that may address this problem include, but are not limited to, diagnostic devices that identify patients at increased risk for addiction, opioid-sparing or -replacement therapies for acute or chronic pain, and devices that monitor the use and prevent diversion of prescription opioids.
Challenge submissions should succinctly describe:
• The novelty of the medical device/concept
• The development plan for the medical device
• The development team
• The anticipated benefit of the device used by patients and the impact on public health as compared to other available alternatives
Medical devices at any stage of development are eligible. Feasibility and the potential impact of FDA participation in development to expedite marketing of the device are other factors that will be considered.
What to Expect After Applying
The goal of the Challenge is to expedite development and review of innovative, safe and effective medical devices to help prevent and treat opioid use disorder. FDA review divisions and management will work closely with developers of devices accepted into the Challenge. In most cases, applicants will eventually submit one or more formal applications to FDA, such as an Investigational Device Exemption (IDE), De Novo, 510(k), or Premarket Approval (PMA). The review of each of these applications will be expedited to minimize review times. The regulatory standard of demonstration of reasonable assurance of safety and effectiveness still applies.
FDA will notify developers whose applications are selected for the Challenge directly. The agency intends to issue a public announcement about applications selected into the challenge and will obtain consent from device developers before publicly disclosing any proprietary information from their application.
If selected into the Challenge, the process will begin with the collaboration phase, an agreed-upon period of interaction (not to exceed 90-days) the goals of which will be: 1) to create a mutual understanding of the medical device, the patient and user needs, the important risks and benefits; and 2) to establish the regulatory pathway forward.
Application Submission Deadlines and Decisions
Submit your application electronically to CDRH-Innovation-Opioid@fda.hhs.gov on or before September 30, 2018. The Agency intends to announce applications selected for the Challenge in November 2018. As many meritorious applications as resources permit will be selected. Following completion of the review, applicants will be notified of their application status with the following possible outcomes:
- NOT ACCEPTED: CDRH will contact applicants whose submissions are not accepted into the Challenge. Applications not accepted for this Challenge can still participate in all the existing regulatory programs at CDRH, including Breakthrough Device designation.
- ACCEPTED: CDRH will contact applicants whose submissions are selected into the Challenge to schedule a teleconference with the appropriate review division.
Application Format:
Applications should be no longer than 7 pages using Times New Roman,12-point font. All content should be written in English and submitted in PDF format, electronically to CDRH-Innovation-Opioid@fda.hhs.gov.
Cover Page
- Company name, address, name of a contact person including their phone number and email address.
- Device name.
- FDA regulatory history: All relevant IDE, 513(g), or Q-Submission numbers (if applicable) should be included.
- Marketing status of the device outside the U.S.
Executive Summary (limit to 1 page)
- A summary of what the device is intended to do.
- The significance of the problem it will solve.
- A summary of the proposed development plan.
Proposal: Should address all the following six sections
Device description and indication for use
- Indications for Use: Provide the intended indication including the patient population for which the device will be used. Note if this is a special population, for example, pregnant women, adolescents, elderly.
- Brief device description: Provide an overview of the product, including principles of operation and properties relevant to clinical function, if known. Images or engineering schematics can be provided as appropriate.
Significance of successful development of the device
- Describe whether and how this device is novel in design.
- Discuss how this device will be more effective than currently available therapies, medical apps or diagnostics, if any exist.
- Describe the anticipated benefits and risks to the patient and the impact on the public health.
Device development plan
- Provide a high-level description of the current development status including currently available evidence of device safety and effectiveness.
- Describe the regulatory development plan, including nonclinical and clinical studies.
- Describe the proposed clinical study design and endpoints to be used.
- Describe the planned marketing application (e.g., 510(k), de novo, PMA).
Quality of the development team
- List the names of essential team members.
- Describe the prior medical device development experience of each essential team member.
Manufacturing
- Describe any prior inspectional history with FDA, if applicable.
- Describe any prototype device production capabilities.
- Describe any capability to produce commercial-scale GMP-compliant lots of the medical device, if applicable.
Value of FDA input
- Describe how the development program for this medical device will benefit from increased FDA participation.
1 Source: 2016 National Survey on Drug Use and Health
Article Source: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm609082.htm
