Replies to post #66872 on Bioelectronics Corp (BIEL)

[LostSaint]

Erchonia: F.D.A. WARNING letters January 1st, 2011....

Before FX 635 was approved:

F.D.A. warning letter full text here

1. Your Zerona Medical laser is adulterated under section 501 (f)(1)(B) of the Act, 21 U.S.C. § 351 (f)(1)(8), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your Zerona Medical laser is also misbranded under section 502(0) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. § 807.81(a).

BIEL getting approved soon....