Bioelectronics Corp (BIEL)

[Johnje]

The innovation challenge is not won in November

Manufacturers are told if they are accepted into the challenge

Being accepted into the challenge does not mean FDA approval..

See below from the fda site...


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.

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.