Continuous Spinal Infusion Investigational Device Exemption

P

phfrasier

#1
I am wondering if anyone has experience with developing the protocols for an IDE and can advise or direct me where to go to find information that would help my company to develop one.

We are considering doing an IDE on a device for Continuous Spinal Infusion but we are wondering how the FDA defines Continuous Spinal Infusion or Continuous Spinal Anesthesia/Anagesia? :confused:
 
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M

MIREGMGR

#2
I am wondering if anyone has experience with developing the protocols for an IDE and can advise or direct me where to go to find information that would help my company to develop one.

We are considering doing an IDE on a device for Continuous Spinal Infusion but we are wondering how the FDA defines Continuous Spinal Infusion or Continuous Spinal Anesthesia/Anagesia? :confused:
It appears that the FDA's classification of existing intrathecal drug pumps is fairly clear.

See, for instance, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2389 (product classification code LKK, class III, submission type = PMA.)

Four makers have products Listed in LKK: http://www.accessdata.fda.gov/scrip...Name=&establishmentType=&PAGENUM=5&SortColumn=

This might answer your second question, unless the reason you would be considering the IDE route is that your device would be significantly different in technology, function or indications for use than the existing products.
 
S

sanjoh

#3
I am wondering if anyone has experience with developing the protocols for an IDE and can advise or direct me where to go to find information that would help my company to develop one.

We are considering doing an IDE on a device for Continuous Spinal Infusion but we are wondering how the FDA defines Continuous Spinal Infusion or Continuous Spinal Anesthesia/Anagesia? :confused:
The one of the best resources I've found is here.

The info from the site will help you understand some of what current studies are doing. Including sample sizes, end points, etc.

One issue to consider is reimbursement. CMS has been hesitant to reimburse (pay for) procedures, devices, etc. that do not show superiority to existing technology.

I would recommend a subject matter expert to assist you in the process.

Good luck with your IDE, should you proceed.
 
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