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Guided Therapeutics, Inc Message Board

  • anttikiiveri anttikiiveri Jun 28, 2013 10:07 AM Flag

    So where is FDA answer?

    Approval/denial of Luviva was dated somewhere 15th May and now its end of july. Some people say they have to give some answers within 45 days of scheduled date. If this true, where is that answer? Tired of waiting. Gonna sell if nothing happens...

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    • Mark told us we would have an answer by the end of the second quarter.WHERE IS IT AT?Like everone else iI am sick of waiting.NEVER AGAIN WILL I GET INVOLED WITH ANYTHING THAT HAS ANYTHING TO DO WITH FDA.WHAT A JOKE THEY ARE.............

    • Due to market complaints about the FDA approving some devices (notably stents) too quickly without sufficient review and subsequent failures in the field, the FDA has opted to slow down the approval process on a case-by-case basis as deemed necessary. The FDA currently has a target of issuing 85% of PMA decisions within the quarter that the 180th day fell. The last reported quarter for this metric is Q4 2012, and they issued 97% of PMA decisions for PMA's where the 180th day fell in that quarter.

      This is the relevant regulation from the Code of Federal Regulations (21CFR814.40):

      Sec. 814.40 Time frames for reviewing a PMA.
      Within 180 days after receipt of an application that is accepted for filing and to which the applicant does not submit a major amendment, FDA will review the PMA and, after receiving the report and recommendation of the appropriate FDA advisory committee, send the applicant an approval order under 814.44(d), an approvable letter under 814.44(e), a not approvable letter under 814.44(f), or an order denying approval under 814.45. The approvable letter and the not approvable letter will provide an opportunity for the applicant to amend or withdraw the application, or to consider the letter to be a denial of approval of the PMA under 814.45 and to request administrative review under section 515 (d)(3) and (g) of the act.