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here we go with the deadlines again. Everyone take a deep breath and buy some on this dip for one and then sit back and relax with not expectation approval until mid summer. That way when it happens prior to mid summer you'll be pleasantly surprised. I can tell you this decision will not happen in February. We'll be luck to have everything submitted for review by mid Feb.
It's on the home page of IHUB's IMGG board under SEC filings
Then you would be the one to explain to others how that exactly works. I know it wont be immediate, but what is the timeframe?
Here is the link: Look at the SEC fling Form D from March 5th 2009. This shows the first placement for Jan 12 of about 12 million roughly. And yes, the other poster is correct in that these will not be available for a couple of weeks. Tomorrow is the first day the holders can begin the process if getting the restriction removed from the certificate and then they must take it to a broker. It may take a few weeks for this to happen.
It is no rumor. This I can agree with. The first placement of the 100+ million shares took place in Jan. of 2009 and it was roughly 12 million. The rest become unrestricted in July through October.
WOW!! It never amazes me how many individuals get off on others misfortunes. Fortunately for us this is not a misfortune but merely the process. I did go back. I went back and pulled all your post. What I have found is nothing but banter that is full of bashing and disrespectful attacks on others. That leads me to ask one question. Why? Why would this person spend all this time attacking others and spreading nonsense? Not a single positive post from you on any company you are posting for. Well partner, I guess you are finally getting your wish. It looks like you get to average down tomorrow and try to save your sorry ass. Good for you!
Once we understand what new information the FDA wants, we will have a clearer picture for the future, but the only questions really that I want answered is:
1. Is this an informal or formal (written ) request? in other words, how does this affect the clock.
2. Images! Can you please be a little more transparent with your shareholder on the images. I for one would like to see the updated images the company is holding. I don't see this as a major request.
I believe this will settle people down.
LONG IMGG
I will say this: I would love for Dean to provide updated Images on the website tomorrow before the CC. I truly believe this would defuse most of the major swings and prevent many of the true investors from second guessing themselves and the company. At this point we are having to provide new information to the FDA, so my question is why would providing updated images hinder the process anymore. Unless the request from the FDA is minor and informal.
Here is the battle within yourself.
Do you roll the dice and say the hell with it, or do you try and get out tomorrow early in the morning only to try and get back in at a later date. If you can even get back in at a later date. Here is the problem with this scenario. Someone will get burnt! I hate to see anyone take a loss or financially get strapped, but this is the name of the game. It is a game! I've seen this many times with the FDA requesting more information and the problem is nobody knows when they will respond. I watched companies submit additional information and then all of a sudden they heard back from the FDA in a matter of days with positive news and then I've watched companies take months to get anything back from the FDA. It really only depends on the scope of the information requested and how prepared the company is with the information submitted. This will tell us how close we are. I hope everyone with questions and concerns will jot them down and ask Dean themselves tomorrow during the CC and maybe just maybe we won't have the roller coaster ride we had these past 60 days. Wow, was it 60 days? Who would have thunk it?
I would be dishonest if I said that I don't have regrets for not cashing out around 1.95, but I rolled the dice and here I am still supporting this product and the company. Luckily for me I don't throw the entire bankroll at a single investment and can sit on this for months to come. For the longs, I wouldn't even watch this trade tomorrow if you can't stomach major swings. Hell, you might want to walk away from this thing for a couple of weeks because the shorts are going to have a field day until this settles back down again. Unfortunately, it looks like our nearest support is the 200 day MA which is around .37 and after that a gap to be filled about .25-.30. This may very well happen and if it does, be ready to pick up some more shares. I just don't think Dean can spin any good out of this news to prevent this from happening.
GLTA LONGS
You obviously didn't read my post too well. Again, another example of someone taking a statement or a comment and twisting it into whatever scenario that want to use it for. If you have followed any of my post you would have seen that I've been saying 60 days from last (AI) submission and not earlier and that this was only a guideline from the FDA. And yes, Dean was hopeful for a 15 to 30 day decision post last submission. If you had followed any of the CC's and or statements made by Dean you would know that this is what he said and people ran with it.
Dean owes us nothing. I for one don't want to hear anything from Dean unless it has APPROVAL attached to the PR. I believe the worse thing he did for our current situation was to give false hope on a 30 day timeline off of his personal gut feeling. He has been great with all the transparency with what is going on with the company, but the "30" day banter was a killer for us because everyone reads into statements instead of looking into facts.
No matter what Dean says or does he can never win, so why say anything at all unless it is an approval PR.
I think everyone is patiently waiting for the news so they can come back on here pretty hard and shove it in the bashers faces. For myself, I'm going to quietly move on with my profits and investment and wait for GE, Toshiba or another to announce a partnership or buyout.
Think about it people! With all the radiation exposure news and the push for advancements in technology, especially in the medical field, this company is poised to take a huge bite out of the market in one way or another.
I see us getting approved here real soon.
I think this board is visited by the more patient investors than that of the Yahoo board. Check out the Yahoo board if you want to see some mickey mouse type of discussions. That board gives me a headache.
Also, take a look at HEB and the manufacturing situation. The FDA has questioned their production facility and standards for some time now.
And that surge looks like it took a few days to materialize after the insider purchases. This may be a late surge sometime later in the week.
ARTICLE ABOUT EXCESS RADIATION:
15,000 will die from CT scans done in 1 year
Scans have higher levels of radiation than thought, researchers say
CT scans: Life-saving or cancer-causing?
Dec. 14: According to new reports in the Archives of Internal Medicine, radiation exposure from commonly performed CT scans may contribute to thousands of future cancer cases. NBC's Robert Bazell reports.
updated 5:14 p.m. ET, Mon., Dec . 14, 2009
CHICAGO - Radiation from CT scans done in 2007 will cause 29,000 cancers and kill nearly 15,000 Americans, researchers said Monday.
The findings, published in the Archives of Internal Medicine, add to mounting evidence that Americans are overexposed to radiation from diagnostic tests, especially from a specialized kind of X-ray called a computed tomography, or CT, scan.
"What we learned is there is a significant amount of radiation with these CT scans, more than what we thought, and there is a significant number of cancers," said Dr. Rita Redberg, editor of the Archives of Internal Medicine, where the studies were published.
"It's estimated that just from the CT scans done in one year, just in 2007, there will be 15,000 excess deaths," Redberg said in a telephone interview.
"We're doing millions of CT scans every year and the numbers are increasing. That is a lot of excess deaths."
CT scans give doctors a view inside the body, often eliminating the need for exploratory surgery. But CT scans involve much higher radiation dose than conventional X-rays. A chest CT scan exposes the patient to more than 100 times the radiation dose of a chest X-ray.
70 million scans done in 2007
About 70 million CT scans were done on Americans in 2007, up from 3 million in 1980. Amy Berrington de Gonzalez of the National Cancer Institute and colleagues developed a computer model to estimate the impact of so many scans.
Doctor: Radiation danger from CT scans 'serious'
Dec. 14: Dr. Rita Redberg, a cardiologist at the University of California at San Francisco and the editor of the Archives of Internal Medicine, says commonly performed CT scans are exposing patients to more radiation than previously thought.
Nightly News
They estimated the scans done in 2007 will cause 29,000 cancers. A third of the projected cancers will occur in people who were ages 35 to 54 when they got their CT, two-thirds will occur in women and 15 percent will arise from scans done in children or teens.
The researchers estimated there will be an extra 2,000 excess breast cancers just from CT scans done in 2007.
Redberg, who wrote a commentary on the studies, said U.S. doctors' enthusiasm for the tests has led to an explosion in their use that is putting patients at risk.
"While certainly some of the scans are incredibly important and life saving, it is also certain that some of them were not necessary," Redberg said.
In a separate study, Dr. Rebecca Smith-Bindman of the University of California, San Francisco, and colleagues analyzed data from 1,119 patients undergoing the 11 most common types of diagnostic CT scans at four institutions in 2008.
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They found radiation dosage varied widely between different types of CT studies, from a median or midpoint of 2 millisieverts for a routine head CT scan to 31 millisieverts for a scan of the abdomen and pelvis, which often involves taking multiple images of the same organ.
By comparison, the average American is exposed to about 3 millisieverts of radiation a year from ground radon or flying in an airplane — a level not considered a risk to health.
The researchers said efforts need to be taken to minimize CT radiation exposure, including reducing the number of unnecessary tests, cutting the dose per study, and standardizing the doses across facilities.
Imaging equipment makers such as GE Healthcare, Siemens, Philips and Toshiba Medical Systems are working to develop low-dose CT scanners.
Yep, you are correct. Go back into IMGG SEC filings and you will see that the first of the 107 million share placement is about 12 million that come due this month. (Which would be the 6 months he was speaking of) The rest become unrestricted between July and October 2010.
So, you can see that only a small fraction will become available this month and the rest will be in the 2nd half of 2010.
Exactly >>>> thanks Imggorbust
mx10001,
I would have to agree with your statement. I'm only giving the information that I have found from my research. Yes, Restricted shares will become available to sell on the open market this month, but not the amount others have posted. I'm only seeing about 12 million, but that doesn't mean the owners are going to flood the market with those shares. And you are correct that it might take a few weeks to file the paperwork which will allow these to become now unrestricted. I'm not totally sure how that process works. From what I have read on the SEC site, the owner of these restricted shares will only be allowed to sell so much of the restricted shares within a 3 month period, depending on a weekly average of trading volume. Please correct me if I'm wrong with my last statement.
Actually, if you are that confused and not sure who to believe then you might want to take a look at the FDA site yourself and try to figure out the process.
90 days is the typical "review period" of a 510K process. These 90 days are only counted while the FDA is reviewing the app. The 90 day review clock stops once the FDA responds for more information and starts again once they have received it and has notified the company of the receipt of the info. For additional information, as in the 2nd or more additional information request from the FDA, a 60 day review is needed by the FDA. We are now getting into that 60 day window from the last submission.
Restricted Shares:
Ok people, I for one am getting tired of the individuals on here posting false information about 100 plus million shares becoming unrestricted next week. So, what I have done is copied and pasted information from both the IMGG SEC filings and the FDA website that pertains to the IMGG filings under SEC rules.
Take note of the filing date of Oct. 6th. If you read under this rule you will notice these shares do not become available for sale on the open market for one year.
Now the first sale of this total offering of 100 plus million shares took place in Jan 09. Now this should make you come to the conclusion that some shares will become unrestricted this month. Per the rules outlined below, this information is in fact true, but not 100 plus million shares. Per my estimate, roughly 12 million shares will become available for sale on the open market this month. The rest of the private offering won't become available for sale until July and then the bulk Sept-October of this year.
The first private placement in Jan 09 was for an offering of $575,000.00 but only $308,000.00 worth of stock was sold at that time. I might be mistaking but I think this was for .025 pps. (which is about 12 million shares)
Anyone else researching this please chime in. Sometimes I have fuzzy math! <<<<my disclosure!
>>>>>>>>>>>>>>>>
SECTION 3. SECURITIES AND TRADING MARKETS ?
? ITEM 3.02 UNREGISTERED SALES OF EQUITY SECURITIES. ?
?
On October 6, 2009, Imaging3, Inc. (the "Company") completed a series ? of private placements of its common stock pursuant to which the Company sold a ? total of 107,059,027 shares of its common stock at a purchase price of $0.025 ? per share raising total capital of $2,676,475.68. The private placements were ? made pursuant to Rue 506 of Regulation D promulgated under Section 4(2) of the ? Securities Act of 1933, as amended. ?
>>>>>>>>>>>>>>>
Rule 506 of Regulation D
Rule 506 of Regulation D is considered a "safe harbor" for the private offering exemption of Section 4(2) of the Securities Act. Companies using the Rule 506 exemption can raise an unlimited amount of money. A company can be assured it is within the Section 4(2) exemption by satisfying the following standards:
The company cannot use general solicitation or advertising to market the securities;
The company may sell its securities to an unlimited number of "accredited investors" and up to 35 other purchases. Unlike Rule 505, all non-accredited investors, either alone or with a purchaser representative, must be sophisticated—that is, they must have sufficient knowledge and experience in financial and business matters to make them capable of evaluating the merits and risks of the prospective investment;
Companies must decide what information to give to accredited investors, so long as it does not violate the antifraud prohibitions of the federal securities laws. But companies must give non-accredited investors disclosure documents that are generally the same as those used in registered offerings. If a company provides information to accredited investors, it must make this information available to non-accredited investors as well;
The company must be available to answer questions by prospective purchasers;
Financial statement requirements are the same as for Rule 505; and
******Purchasers receive "restricted" securities, meaning that the securities cannot be sold for at least a year without registering them.******
While companies using the Rule 506 exemption do not have to register their securities and usually do not have to file reports with the SEC, they must file what is known as a "Form D" after they first sell their securities. Form D is a brief notice that includes the names and addresses of the company’s owners and stock promoters, but contains little other information about the company.
In February 2008, the SEC adopted amendments to Form D, requiring that electronic filing of Form D be phased in during the period September 15, 2008 to March 16, 2009. Although as amended, the electronic Form D requires much of the same information as the paper Form D, the amended Form D requires disclosure of the date of first sale in the offering. Previously, the closing date of an offering was used as the first date of sale. The Office of Small Business Policy has posted information on its web page about the filing requirement for the new Form D.
give or take a few days! We are close to having this approved. I just know that I wont be on the sidelines watching this take off once it gets the nod from FDA. I jumped ship on another company prior to FDA approval because they were looking at a possible bankruptcy and the next week they exploded. They are now trading in the 20 bucks range, and the bashing was worse then this. This device is a game changer. Take note! This company will be bought out by one of the big players and I wouldn't put it past Dean to already have the contract inked and just waiting on approval to announce it.
I would like to see this information you speak of. Show us something that proves these restricted shares are coming unrestricted next week. Of all this talk about shares becoming unrestricted next week, not one person has posted any single bit of evidence proving shares are becoming unrestricted.
IMGG heard from the FDA on the receipt of the additional information on the 19th per one of the posters on here.
The FDA gives a timeframe "guidance" for this process which in broken down in events. 90 days is usually the normal "total" length of time for a decision as long as no other information is needed. 60 days is the time the FDA uses after any "additional information" is requested and received.
I cant leave a private reply, but if you take the fact that the company said they heard from the FDA on the 19th of November about the receipt of the application then I would guess we have about another week or two before the 90 days is up.
Found this information in an article sent to me this morning: Hold tight people, we have a winner. Just keep VRMLQ in the back of your head. In just 5 short months this company went from a penny to over 30 bucks. Just Imagine if you had invested only 1k back when it was a penny.
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
Further fueling the biotech boom of 2010 will be the incredible advances that are being made in technology. Some of these things sound like they come from science fiction movies...
“Biotechnology is revolutionizing medicine in ways that were unimaginable just a few years ago...”
- Alan Greenspan I'm talking about genomics, microarrays, biomarkers, pharmacogenetics, recombinant DNA and proteomics.
And based on what's coming down the FDA pipeline, this could be a watershed year for amazing new treatments...
Take Power 3 Medical (PWRM) for example.
This company uses proteomics to detect diseases far earlier than the tests being used now. Imagine if you could detect a disease like Alzheimer's or breast cancer one, two, or even FIVE years earlier than is now possible .
I don't have to tell you how that would improve treatment and boost survival rates!
With millions of people affected by these diseases, you can see the tremendous potential of this arm of biotechnology.
Another company, AVAX Technologies (AVXT) has a Stage 3 drug named MVax that may one day treat late-stage melanoma.
The amazing thing is, the vaccine comes from the actual tumor inside the patient! This company pulls out the cells, modifies them, and then injects them back in the body.
Needless to say, these are some amazing technologies. And investors have noticed...
Power 3 Medical soared 1,980% and AVAX Technologies skyrocketed 1,712% towards the end of 2009. That's nearly a 20-fold increase in your initial investment in each stock!
Try getting those returns with boring old blue chips! It just isn't going to happen...
And I haven't even told you the best reason why you must get into biotech stocks RIGHT NOW!
I still haven't seen any hard evidence showing that these shares become unrestricted next week. If anyone has this info I would like to see it posted. Regardless, this is still a strong hold. I looked through many of the 510K clearances given in December on the FDA site and all of them were running around the 60 day period before decision. Some given prior to the 60 and other a few days after, but for the most part it looked like most were coming in around 60 days post submission of last request.
IMMG will gain approval from the 32bit images with the understanding that further improvements to the software is inevitable. The FDA only wanted improvement on the resolution of the images previously submitted, and since that submission the only thing the FDA came back with was a request for a "Labeling" clarification. If the FDA had issues with the current images submitted from the 32bit platform, they would have responded by now. Labeling is one of the last things to clarify before approval is granted.
To clarify: The labeling issue we are correcting most likely is for safety reasons, just like GE putting a label on a microwave warning people not to put metal in the device or serious injury may occur. It's a label for the dumb asses.
I couldn't have said it better myself. I'm happy to see someone on this board is using some common sense. I see people posting information such as "Dean submitting the wrong application", "GE/Toshiba conspiracy theories" and the whole gambit of reasons why this thing is being delayed and none of it is remotely close to the truth. This is the FDA people! They are not part of any conspiracy and the appropriate application was worked out between them and Dean a few years back. Do you really think Dean submitted the wrong application? Do you really think the FDA will ever take a chance, especially with this administration, to get caught up in some conspiracy, like getting bought by GE/Toshiba to outright delay a decision or deny a device such as this? Come on! Do you really? My advice for those that are believing this mess is to sell, sell, sell and move on to something else. For us Longs, we have completed our DD and have read the 510k process word for word; which is posted on the FDA site for all to see, and know that this was never a 30 day decision from last submission.
people should get all the facts. The "target" for one has not been missed and two it is for guidance only and not a requirement to meet.
Approval Date
It's obvious here on the IHUB board that most seem to be more optimistic and long compared to the Yahoo board where it is now being littered with banter full of disgraceful comments and pure bashing.
If you have truly done your DD and have followed this company then you know the true potential with this technology. I've been saying all along that this decision would come in Jan 2010, since it is a Radiation emitting device and per the guidelines by the FDA (printed in black and white) stating 60 days after Additional Information request. You better believe now with the radiation scare from other devices the FDA will use the entire 60 days and possibly a couple more to bring this to a conclusion.
To all the investors here long on IMGG, good luck in 2010. Hopefully this long wait is coming to an end for us on positive news from the FDA or an acquisition from one of the bigger players. I believe the one thing that took place over the last couple of months in favor of IMGG longterm potential was the overexposure Radiation news from other devices. IMGG is on someones radar right now for an acquisition and when it is announced this thing will explode. Given how close IMGG is to approval, this is an announcement that can take place at any time. For example, take a look at what happened to ATHX when they were acquired by a bigger player. Yeah I know this is a stem cell stock, but this is a company that has no line of products at the moment in any phase of clinical trials and nothing approved by the FDA. All I'm saying is, ANYTHING IS POSSIBLE!
Stay strong IMGG longs! 2010 is the year for IMGG!
nope can't do it. I said Jan 11th all along. Before the Bell.
Jan 11th before the bell!
Biomedreport target date was just an estimated timeframe for "Hopeful" approval before the last submission was sent to the FDA by Dean. Take a look at the info below. This comes directly from the FDA site.
It is actually 60 days from the last submission and again this is a government agency, so it is only a "Guideline".
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".
if you go back and listen to the CC's you will hear him say that, in the past the FDA usually responds within 15 to 30 days with any new request, not a complete decision. He also stated that it is a good thing the FDA is taking longer than the 30 days to respond. What I have posted are facts from the FDA site and nothing more.
Lets take this one step further. If you take a look at the guidance performance for the FDA that is posted on the site, you will see how they have performed in the past few years to meet these guidelines (dates).
After the second or Additional Information request: 60 days
2005 70% received notice by this timeframe
2006 80%
2007 90%
2008 ?
2009 ?
With recent concern of FDA dragging their feet you would think this percentage would get better!
60 days from last AI 1 minute ago
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".
Sentiment : Strong Buy
Re: DECISION DATE HAS NEVER CHANGED! (60) DAYS) 24-Dec-09 12:19 pm
Lets take this one step further. If you take a look at the guidance performance for the FDA that is posted on the site, you will see how they have performed in the past few years to meet these guidelines (dates).
After the second or Additional Information request: 60 days
2005 70% received notice by this timeframe
2006 80%
2007 90%
2008 ?
2009 ?
With recent concern of FDA dragging their feet you would think this percentage would get better!
Rating :