How to Classify a Medical Device

  • Thread starter CollegeHelpRequest
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CollegeHelpRequest

#1
Hi,

I'm a student in a Regulatory Affairs course. I could use your insight. I know this will initially be very broad, as I don't know enough on the subject to refine yet. But I hope the group could help guide me on this learning journey.

In a scenario where you are first meeting with a project team (marketing, engineers, etc) and they provide a wish list for what they envision a new product to be (and of course want it to do everything, have fantastical claims they want to make, launch fast, and be new and innovative)... How do you start digging through this to provide guidance to the team so that they don't overreach? With the goal to keep the product in a 510k submission process?

Are there any guidances or checklists to help with best practices in determining med device product classification between a Class 2 and 3 device, claims, project checklist, or just guidance on what points could be used to question the team and refine direction for realistic project planning?
 
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somashekar

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#2
Can you read THIS page and the related links from thereon ...
Also see the threads in the similar discussion threads down this page.
Do come back with your feedbacks...
Good luck.
 
#3
Hi Somashekar,

I have a checklist which is designed according to the rules of classification compliance for MDD. I am as well looking for similar checklist for other regulatory classifications - USA/FDA, Canada/HC, Australia/TGA, etc..

I hope this help.

With regards
 

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MIREGMGR

#4
There is no such consistent set of rules for US FDA, which has a legacy system. It's reality that there are inconsistencies in the legacy classification codes.

In some situations, it's possible to classify a new device into either Class I or II, or II or III, depending on what definitional approach one takes to analyzing the device's nature and function. I know of no way to simplify the knowledge of those unclear-boundary situations. They're just dependent on expertise.
 
#5
Hi MIREGMGR,

I accept your comments sir. There is no consistency defined. But at the least a checklist of rules (useful for manufacturers) in other markets as like in Canada/Health Canada, Australia/TGA, etc will be lot helpful.

With regards
Sharma
 
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