Bioelectronics Corp (BIEL)

[markjohn62]

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 [e-mail] 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:

That would be around 9 months out for Recovery Rx. I hope they submit the 510k before acceptance into the challenge, we have to wait to see if the FDA is ok with that, can't piss them off at this stage.

From Sree Koneru

Thank you for your e-mail. We are in the process of seeking guidance from the FDA on the appropriate time to submit the RecoveryRx 510(k), with respect to the Innovation Challenge. The Allay study is going strong and we expect a timely completion this year, however we do not have additional information on when the 510(k) will be filed. Any updates that we have regarding these two matters will be made publicly available via a press release.

Good link Gramps!