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FDA Rules on Medical Device Classification Listings?


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class ii medical device, fda (food and drug administration), fda classification, fda unified registration and listing system (furls)
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  Post Number #1  
Old 30th March 2012, 05:14 PM
ryno fan

 
 
Total Posts: 34
Question FDA Rules on Medical Device Classification Listings?

Hello,

1. My understanding of FDA's requirements for Device Listing for medical device manufacturers is to list all Class II and higher devices on FURLS (FDA's Unified Registration and Listing) system; and at least 1 representative Class I device from each device family (classification number and product code). Is this accurate?

2. Is there a requirement for manufacturers to list their marketed medical device accessories?

Thanks for the help.

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  Post Number #2  
Old 30th March 2012, 07:29 PM
JeantheBigone

 
 
Total Posts: 65
Re: FDA Rules on Medical Device Classification Listings?

If the accessories have a product code then they will have to be listed. If they do not have a product code then as far as I know there is no way t list them

http://www.fda.gov/MedicalDevices/De.../ucm053185.htm
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  Post Number #3  
Old 30th March 2012, 10:46 PM
ascherp

 
 
Total Posts: 56
Re: FDA Rules on Medical Device Classification Listings?

All devices marketed in the United STates have to be listed on FURLS, including all class 1 devices. Class 2 and 3 devices need to be listed as well, but you would additionally need a premarket notification number, such as a 510(k) or PMA number, to do so.

Some accessories have their own product code. Look up NBH as an example.

If an accessory does not have its own product code it is usually classified according to the device it is used with. So it may be class 1, but could be class 2 if intended for use with a class 2 device.

You can find information on listing requirements on the Medical Device home page of the FDA under the links Device Registration & Listing and Device Advice. I also suggest going to the FDA home page and then following the links Training/Continuing Education and CDRH Learn for the online courses available on basic topics like registration and listing.
  Post Number #4  
Old 31st March 2012, 10:20 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: FDA Rules on Medical Device Classification Listings?

Quote:
In Reply to Parent Post by ryno fan View Post

1. My understanding of FDA's requirements for Device Listing for medical device manufacturers is to list all Class II and higher devices on FURLS (FDA's Unified Registration and Listing) system; and at least 1 representative Class I device from each device family (classification number and product code). Is this accurate?

2. Is there a requirement for manufacturers to list their marketed medical device accessories?
I agree with the comments above on question 2, but an additional comment: the key question regarding an "accessory" is not what you call it or whether you market it as an accessory or a device. It's whether it objectively meets the definition of a device. If it does, then it's a device and has to be listed.

As pointed out, some products that do not meet the definition of a device nonetheless have to be listed because there is a specific ProCode for that accessory type.

On question 1, the answer depends on your definition of "product family".

If for instance you make 500 minor dimensional and feature-detail variants of a camera drape, you could internally document that all of those products belong to your "camera drape" family. You would have a single listing for "camera drape". The key consideration is that all the product family members have the same ProCode.

You however could not group together several towel drapes, camera drapes, microscope drapes, slush machine drapes, etc. and call them a single product family, because they have various ProCodes.

There is no distinction between Class 1 and Class 2 regarding "product families". If you offer several minor variants of a product, all having the same basic description and intended use and the same ProCode, they can be a product family.
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