Making a change to an approved Medical Device

M

mghaleb

#1
Hey Every one,

i have a question regarding a approved medical device (class 1) in US which we will change the Hardware and Software?
what must we bear in mind? must apply for a new Registration? or Report the FDA about the Modification? which documents must we give later?

Thanks in Advance,
Ghaleb
 
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melissa237

Starting to get Involved
#2
On the FDA's website they have a guidance document/decision tree to use specifically for determining if you need to submit a brand new device application, submit a change notification or just document the change to file. I'm sorry but I don't remember the name of the document. But I'm sure you can type in to their search bar something that will get you there.

Hope this helps!
 

Ronen E

Problem Solver
Staff member
Moderator
#5
The advice given above is relevant to devices classified such that they require a 510k submission. Most class I devices don't require that.

If the device post-modification falls under a procode that doesn't require a 510k (again, most procodes under class I don't), then you don't have to worry about whether or not a 510k is required (or a note to file). All devices (including class I) are subject to the General Controls. Based on the original device already being cleared (adequately, I presume, since FDA is not involved in pre-market clearance of most class I devices), the General Controls have already been applied and are continuously being maintained. As such, all that is required is continuation of practice as already established, including all provisions pertaining to device changes.

Some class I procodes are also GMP exempt, which means that the quality management system requirements are very limited. Even those that are not GMP exempt, are likely to be exempt from Design Control (21 CFR 820.30). The processes (and documentation) required by the regulations for device changes depend on the required level of quality system (GMP exempt / GMP without Design Control / GMP including Design Control). This would be defined by the applicable procode. It's essential to understand upfront what procode the device would fall under after the change.

Cheers,
Ronen.
 
Last edited:

Mark Meer

Trusted Information Resource
#6
Thanks for catching that Ronen! Essential to check the procode.
...easy to forget the different regulatory universe that is Class I. :lol:
 
J

Julie O

#8
If the device post-modification falls under a procode that doesn't require a 510k (again, most procodes under class I don't), then you don't have to worry about whether or not a 510k is required (or a note to file).
I've seen people work through this process this starting with, "This is a Class I device," which leads them to "We are making changes to a Class I device," which leads them to "We now have a modified Class I device." Not exactly.

Yes, they did modify a Class I device, but whether the modified device is a Class I device is a different question. If the modified device fits the description associated with regulatory classification number* for the original device, then yes. If it fits the description associated with some other regulatory classification number that is also Class I, then yes. Otherwise, not, and you start looking for a Class 2 predicate or consider going De novo.

When you modify a Class I, I think it is always wise to re-read the regulatory description associated with that device, to make sure the modified device still fits.

_______________________
*I think this must be what Ronen refers to as a procode, but I'm not sure because I've never heard this term before.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
_______________________
*I think this must be what Ronen refers to as a procode, but I'm not sure because I've never heard this term before.
I was referring to the FDA's 3-letter code, which is more specific than the regulation number. Where the nickname "procode" came from I'm not sure; I picked it somewhere along the way, and have been using it for some years. I always thought it's short for Product Code.
 
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