Bioelectronics Corp (BIEL)

[Chyna9]

The way I understand it, they are entering the innovation challenge, and not filing a 510(k) now. Some applicants will be selected for it. That doesn't mean it's already been selected. It may or may not be. If the biel product is selected, the way I understood it, is then 510(k) and/or other related applications, will be filed and expedited review will take place. That review may or may not lead to approvals.

It will not be known until November 2018 which entrants are accepted into the Challenge.

From what I am understanding, they did not and will not be submitting a 510(k) on RecoveryRx, and instead entering the product into the innovation challenge. Which may or may not lead to a 510(k) being submitted.




The FDA intends to announce applications selected for the Challenge in November 2018.

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/ucm609082.htm