the clock starts when the FDA says it starts it is really that simple
How can BIEL know when the FDA even opened the envelope?
get real - the process is an FDA process - they invented it, they control it and we now know their received date is well after the actual envelope delivery date.
I suggest you remove your dark glasses and watch what happens.
I'm not saying clearance is assured - history has told us that - but with the extra time for studies and the involvement of a top ranked FDA specializing law firm they have a far better chance this time.
Per an FDA Industry analyst 167 days is the current average time from 510k submission to decision based on historical data from 2010-2014. This would put BIEL's 510k submitted 8/6/2015 with an expected decision date of 1/20/2016. It could happen sooner or it could happen later.
"It takes an average of five months for a 510(k) submission to clear. More specifically, Emergo discovered that between 2006 and 2011 the length of time it took for 510(k) submissions to be reviewed and cleared steadily increased. But, beginning in 2012 and continuing through 2013, this timeframe stabilized."
"Almost two out of three 510(k) applications are cleared within six months. Although the FDA sets goals to review and respond to 510(k) submissions within 90 days, it is an uncommon occurrence thanks to the time required for you to respond to additional information (AI) requests. “The 90 day goal set by the FDA should largely be ignored when you are trying to determine how long it will actually take to get your 510(k) reviewed and cleared,” Schorre concluded. Plan on the process taking closer to six months."
The FDA had to agree to performance goals to be able to increase their fee structure per the MDUFA. Per the FDA website these goals are recommendations not requirements.
"The Medical Device User Fee Amendments of 20121 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize FDA to collect user fees for the review of certain premarket submissions received on or after October 1, 2012, 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 certain performance goals and implement improvements for the medical device review process."
"Performance goals were initially negotiated and agreed to under the Medical Device User Fee and Modernization Act (MDUFMA) of 2002 (Public Law 107-250) for PMAs filed in FY 2003-2007 (now referred to as MDUFA I). New performance goals and process improvements were incorporated in the Food and Drug Ad m inistration A mendments Act (FDAAA) of 2007 (Public Law 110-85) for PMAs filed in FY 2008-2012 (now referred to as MDUFA II). For 510(k) submissions received during FY 2013-2017, the performance goals and process improvements are outlined in the letter from the Secretary of Health and Human Services (the Secretary) to Congress2 and are further described 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."
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