Bioelectronics Corp (BIEL)

[ghost42]

DeNovo

These devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. §351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The kind of information that your firm needs to submit in order to obtain marketing authorization for the devices is described on the Internet at www.fda.gov/cdrh/devadvice/3122.html1. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.

uk, can you help me decipher the above parargraph and any meanings it has about lack of submissions. I also included above the url to the FDA site concerning DeNovo process.

I sense that there is something missing. I think we need to reaffirm the dates for denovo submissions and whether there was any response fron FDA.