Introducing a new peripheral for cleared device - Is Validation required?

S

SonjaS

Hello Covers :)
Can anyone help on the following please:
What are the regulations/requirements when introducing a new peripheral (barcode scanner, PDA device or similar) for a 510k cleared device (BECS), in terms of validation? I'm asking from BECS' manufacturer point of view.
In our submission we listed the devices included in the validation. But as technology moves on, some of these devices are no longer manufactured / supported.
If a new peripheral device is used, what is the validation scope expected by FDA? Also, is 510k needed for such change?
thanks in advance!
 
S

SonjaS

Re: Introducing a new peripheral for cleared device - validation req. ?

thank you treesei.. :thanx:

i'm familiar with the guidance and the flowcharts on deciding when to submit a 510k for a change... there is one section that might be applicable to my case- the technology or performance change - and according it - there is no need for a new 510k since the change does not introduce new "Intended use" or other of the criteria.. At least that is how I see it..
Not sure about the validation requirements though..

Lets see if here are some more opinions :)
 
I

isoalchemist

Re: Introducing a new peripheral for cleared device - validation req. ?

Whenever you make a change there should be some level of validation documented in the medical device world (and most others). It may be a very "simple" effort depending on the component and how integral it is to the device, but IMHO you need more than a set of specifications that say it should work. I'm sure you have done some testing on it to prove it works with your system, use it.

I know of at least one instance where an international company made a change that only worked in half the world. The specs looked the same, but in real use the performance differed, because of the situations it was used in.
 
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