From Yahoo: DECISION DATE HAS NEVER CHANGED! (60) DAYS) People please read the following which I have copied and pasted from the FDA site. The decision date was really never going to be any earlier than 60 days from the last AI (addition information) submission sent by Dean. I think Dean was hopeful for the 30 day decision given his relationship with the FDA but I truly believe he should have kept the information to himself and told everyone to take a look at the FDA guidelines. It clearly states 60 days from the second or later AI request and submission. This would put us around Jan 12th if the FDA received the submission by November 12th. Of course this is an estimate plus or minus a couple of days. AGAIN!!! ANY DAY NOW! STAY STRONG AND HOLD ON TO YOUR SHARES!
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), Public Law 107-250, amends the Federal Food, Drug, and Cosmetic Act (the act) to provide the Food and Drug Administration (FDA) new responsibilities and resources. A provision of MDUFMA authorizes FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2002, including premarket notification submissions (510(k)s). The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet the performance goals identified in the letter from the Secretary of Health and Human Services to Congress (Goals Letter)1 and summarized below.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidances means that something is suggested or recommended, but not required.
1This letter can be found on the Internet.
II. Purpose
The purpose of this document is to assist agency staff and the device industry in understanding how various FDA and industry actions that may be taken on 510(k)s should affect the review clock for purposes of meeting the MDUFMA performance goals.
III. 510(k) Performance Goals
For 510(k) submissions, the performance goals contain both cycle (i.e., "first action" and "second and later action") goals and decision goals. A "cycle" (or review cycle) is the period of time (in FDA days2) beginning with the date FDA receives the 510(k)3 and ending with the date FDA issues a letter requesting additional information or announcing a "decision" (e.g., substantially equivalent (SE) or not substantially equivalent (NSE) determination). More than one cycle may occur before FDA issues its decision on the 510(k) submission.
The table below summarizes the 510(k) performance goals under MDUFMA. FDA has committed to meeting the following action and decision goals for a specified percentage of submissions, depending on the fiscal year:
an FDA decision (i.e., issuance of a SE or NSE determination letter) will issue within 90 days (cumulative FDA review time)
first action additional information (AI) letters will issue within 75 days
subsequent action additional information letters will issue within 60 days.
Table 1. 510(k) Performance Goals
Action Review Time
(FDA days) Performance Level (by FY)
(--- indicates no quantitative goal)
2003 2004 2005 2006 2007
FDA decision 90 --- --- 75% 75% 80%A
First AI letter 75 --- --- 70% 80% 90%
Second or later AI letter 60 --- --- 70% 80% 90%
2The term "FDA days" refers to the amount of time a submission is under review by FDA and does not include the time when the clock has been stopped.
3The recorded receipt date of a 510(k) submission is the date the submission is received by FDA or the date US Bank notifies FDA that payment of all fees due has been received, whichever is later. For additional information, see "Premarket Notification [510(k)] Review Fees". Rating :
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