Regulatory Open Forum

Hello RAPS Expert,

We are class I (non medical, non measuring) medical devices manufacturer and also sell accessories separately and with the wheel chair as well to enhance its functionality.

Do we need to list all accessories in FDA devices listing database?

It'd be huge list though. 

Thanks 

Hi Anon

If you have a huge catalog then you already have many UDIs and many GUDID entries.

FURLS is a little more flexible about grouping families of devices, since the catalog number or model number is not currently required there. But yes, every device has to be listed in FURLS, including device accessories.

Hello RAPS Expert,

We are class I (non medical, non measuring) medical devices manufacturer and also sell accessories separately and with the wheel chair as well to enhance its functionality.

Do we need to list all accessories in FDA devices listing database?

It'd be huge list though. 

Thanks 

Hello Anon,

Medical device listing in the United States is fairly flexible highly depending on how the product and any accessories are structured.  There are other purposes for the medical device listing such as importation or review during an inspection.  There is no rules or even guidance on what should or should not be in the medical device listing from a parent device and accessory perspective; the FDA leaves this up to the manufacturer.  Though as mentioned, the FURLS database listing could be properly identified with a "family" or grouping of medical devices which would convey all accessories in from different groups or individually.

Hi Anon

If you have a huge catalog then you already have many UDIs and many GUDID entries.

FURLS is a little more flexible about grouping families of devices, since the catalog number or model number is not currently required there. But yes, every device has to be listed in FURLS, including device accessories.

Hello RAPS Expert,

We are class I (non medical, non measuring) medical devices manufacturer and also sell accessories separately and with the wheel chair as well to enhance its functionality.

Do we need to list all accessories in FDA devices listing database?

It'd be huge list though. 

Thanks 

In a nutshell, medical device accessories are regulated by the FDA as medical devices. All medical devices (whether they are parent devices or accessories) must therefore comply with the requirements of the item's applicable classification regulation (i.e., the regulations at 21 CFR Part 862 through 898).  If an accessory is under a different classification regulation or product code than the parent device, then the accessory will require its own medical device listing.

Hello Anon,

Medical device listing in the United States is fairly flexible highly depending on how the product and any accessories are structured.  There are other purposes for the medical device listing such as importation or review during an inspection.  There is no rules or even guidance on what should or should not be in the medical device listing from a parent device and accessory perspective; the FDA leaves this up to the manufacturer.  Though as mentioned, the FURLS database listing could be properly identified with a "family" or grouping of medical devices which would convey all accessories in from different groups or individually.

Hi Anon

If you have a huge catalog then you already have many UDIs and many GUDID entries.

FURLS is a little more flexible about grouping families of devices, since the catalog number or model number is not currently required there. But yes, every device has to be listed in FURLS, including device accessories.

Hello RAPS Expert,

We are class I (non medical, non measuring) medical devices manufacturer and also sell accessories separately and with the wheel chair as well to enhance its functionality.

Do we need to list all accessories in FDA devices listing database?

It'd be huge list though. 

Thanks