Bioelectronics Corp (BIEL)

[markjohn62]

If they are accepted into the challenge they will need to do a 510K. No bait and switch.

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 the 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.

ActiPatch fits well into the challenge

Criteria for Challenge Application Review

The Challenge was 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.