Absolutely Correct GG, FDA made the "effective on
Post# of 8403
(Total Views: 440)
Posted On: 04/17/2019 11:36:55 AM
Absolutely Correct GG, FDA made the "effective on women" declaration just 5 months ago.
I was looking through last week's 510K Clearances yesterday, there were 55 of them. 13 of those Clearances were for 510Ks submitted after BIEL's 2/7/2019 submission date. 8 were submitted in March, approved in the first half of April.
IMO, based on how recently the previous submission was, this should have been a 60 day project to nail down labeling, instructions, ect.. If the FDA tries to drag it out past 90 days, which would be 5/7, BIEL needs to play hardball and bring in the lawyers to keep the FDA honest.
Those who have been around BIEL for several years will recall the important roll BIEL's Legal Team, composed of several former FDA employees, played in the Knee/Foot Clearance of 2017.
The FDA was pressing for a change from the 510k path to the De novo path for Clearance. BIEL's Lawyers told them they were wrong and gave examles of previous FDA decisions that supported BIEl's position. The FDA folded because they knew they would be in court if they did not Clear ActiPatch.
Here is a link to the FDA 510k Database, updated each Monday:
https://www.accessdata.fda.gov/scripts/cdrh/c...mn/pmn.cfm
I was looking through last week's 510K Clearances yesterday, there were 55 of them. 13 of those Clearances were for 510Ks submitted after BIEL's 2/7/2019 submission date. 8 were submitted in March, approved in the first half of April.
IMO, based on how recently the previous submission was, this should have been a 60 day project to nail down labeling, instructions, ect.. If the FDA tries to drag it out past 90 days, which would be 5/7, BIEL needs to play hardball and bring in the lawyers to keep the FDA honest.
Those who have been around BIEL for several years will recall the important roll BIEL's Legal Team, composed of several former FDA employees, played in the Knee/Foot Clearance of 2017.
The FDA was pressing for a change from the 510k path to the De novo path for Clearance. BIEL's Lawyers told them they were wrong and gave examles of previous FDA decisions that supported BIEl's position. The FDA folded because they knew they would be in court if they did not Clear ActiPatch.
Here is a link to the FDA 510k Database, updated each Monday:
https://www.accessdata.fda.gov/scripts/cdrh/c...mn/pmn.cfm
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