Bioelectronics Corp (BIEL)

[StockinUp]

This tells me that the comments posted by credible sources, such as doctors, and those from test subjects and trial users saying "This device not only reduced or eliminated my psin, it also cause no possible side effects" will be used by the FDA to eliminate the need for special controls and satisfy any potential risk with general controls (labeling).

We know from the FDA documentation that they look for an UNREASONABLE risk, and our risk is 1 or 2 on a scale of 10. We are heading to Class I. I can feel it.

The FDA, from their own documentation, told us that they are required to place it in the lowest class possible and it qualifies as a Class I. There is no denying that from a reasonable, sensicle, and logical perspective.

The FDA will review and consider comments made in response to the issuance of the proposed order. The FDA will also consider changes to the proposed classification (and special controls for Class II devices) based on its review of the comments