Sonosite

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Anonymous said:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

Where is the 510(k) pre-market submission?
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I posted the link for a reason. ALL devices must be submitted and reviewed for 510(k) pre market clearance. Even a small revision to something as simple as a ERCP disposable. The filing is a formal requirement by the FDA and exemptions are minimal. If this will be used in, on or near the human body it must get FDA 510(k) clearance for appropriate labeling and use.

So, I will ask again in an effort to bring forth TRUTH as I do not know the status of your X-Porte platform and have absolutely 100% NO INVESTED INTEREST one way or the other.

Or better yet, as an employee you can always ask your compliance department for the status, in an email requesting a copy of the 510(k) submission number.
 












Anonymous said:
I posted the link for a reason. ALL devices must be submitted and reviewed for 510(k) pre market clearance. Even a small revision to something as simple as a ERCP disposable. The filing is a formal requirement by the FDA and exemptions are minimal. If this will be used in, on or near the human body it must get FDA 510(k) clearance for appropriate labeling and use.

So, I will ask again in an effort to bring forth TRUTH as I do not know the status of your X-Porte platform and have absolutely 100% NO INVESTED INTEREST one way or the other.

Or better yet, as an employee you can always ask your compliance department for the status, in an email requesting a copy of the 510(k) submission number.
Click to expand...

The FDA 510(k) clearance is streamlined from years ago. The process is different as well.
No worries here guys, this is a fast track approval for a complete , fully functional product
 
























Anonymous said:
The FDA 510(k) clearance is streamlined from years ago. The process is different as well.
No worries here guys, this is a fast track approval for a complete , fully functional product
Click to expand...

So to translate are you saying "don't worry guys. We have utilized the FDA's CDRH Medical Device Innovation Initiative to accelerate the approval process."?

If that is the truth the the X-porte indeed represents a exceptionally new technological advancement over current technologies - since that is a prerequisite to use the "Innovation Pathway".

That would be a relief for the sales force to hear. I just don't understand the generalized sales pitches
People need information to be confident the Company they represent is truthful.

Fine line between protecting innovative technology and dispelling fear and myth.
 






Anonymous said:
So to translate are you saying "don't worry guys. We have utilized the FDA's CDRH Medical Device Innovation Initiative to accelerate the approval process."?

If that is the truth the the X-porte indeed represents a exceptionally new technological advancement over current technologies - since that is a prerequisite to use the "Innovation Pathway".

That would be a relief for the sales force to hear. I just don't understand the generalized sales pitches
People need information to be confident the Company they represent is truthful.

Fine line between protecting innovative technology and dispelling fear and myth.
Click to expand...

No relief for the sales team. We have stumbled on a major issue that our awesome leadership team has been hiding from us. DO NOT plan on seeing this out in August, September. or October for sure!
 




























































Anonymous said:
Is the poster with all the FDA 510 k info implying that we are not supposed to be demoing roadshow?
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Not at all. The FDA allows preapproval display under 21 CFR 812.7. It is well understood to advance technology and acquire much needed peer input that unapproved devices will be shown and displayed. Clinical trials are the foundation to approval.

I never said or implied the X-Porte device should not be out on road or tradeshow or facility display and clinical trial. Fujifilm Somosite's RA/QA Compliance department is responsible to ensure their activities are in compliance with the pre approval requirements and guidelines stipulated by the FDA.
 






Anonymous said:
Not at all. The FDA allows preapproval display under 21 CFR 812.7. It is well understood to advance technology and acquire much needed peer input that unapproved devices will be shown and displayed. Clinical trials are the foundation to approval.

I never said or implied the X-Porte device should not be out on road or tradeshow or facility display and clinical trial. Fujifilm Somosite's RA/QA Compliance department is responsible to ensure their activities are in compliance with the pre approval requirements and guidelines stipulated by the FDA.
Click to expand...

Whatever- I don't give a crap - I just want to know when we can sell it
SP should have his ass in a sling by now.
 






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