FDA Corrections & Removals - Industry Practice for Repairs

sreenu927

Quite Involved in Discussions
#1
Hi,
I am just thinking that for chemistry analyzers (IVD instruments) which do not have a direct impact to the patient safety, how do companies report their removals and corrections.

If there is any replacement of power boards or repair at the customer site or at the manufacturing site, without reducing any risk to health of the user, then are these considered to be reportable repairs (corrections or removals)?

For such IVD instruments, are all repairs reportable under CAR (Correction and Removal regulations)? I don't think so.
How does Companies/Industry practice?

Please share your thoughts!

Regards,
sreenu
 
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#3
I'm not in the field of IVDs, but IMHO 21CFR820.200 (c) applies here: Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of ?820.198.
 
M

MIREGMGR

#4
My view is that field upgrade/preventive-maintenance (PM) actions are not reportable as Corrections unless they are related to an Adverse Event per 21CFR 803, or constitute a substantial design change for which premarket notification would be required.

A "repair" on the other hand would seem to inherently involve patient risk, at least at the level of non-availability of service. If however the non-availability of service resulting from the action is minimal relative to system use-frequency due to good scheduling, ready availability of components, design-for-maintenance and so forth, then perhaps the action can be characterized as maintenance instead of repair and the patient risk regarded as insignificant.
 
Last edited by a moderator:

sreenu927

Quite Involved in Discussions
#5
When you say "availability"- how soon or is there any timeline? I know the regulations do not provide any specific timeline and is instrument or reagent kit or assay dependent based on "reasonably suggests"..but is there any industry guidance or practice that if the service is provided with in a reasonable timeline of x days, then it is ok, else considered to be a removal or correction case!

Thanks,
Sreenu
 
M

MIREGMGR

#6
I don't know of any guideline or common practice. As far as I know, the situation is unusual enough that every instance is dealt with individually.

In my view, non-availability for say three days due to a need for repair is reasonable if the equipment is used on average every six days. I could write a rationale for that circumstance.

If on the other hand the equipment is used on average once daily, and will be down for several days, then you have a potential patient risk situation due to non-availability that I wouldn't be able to rationalize, and I might feel obligated to Report as a field action.

Obviously this is all about judgement calls and how you write your rationale.
 

sreenu927

Quite Involved in Discussions
#7
Hi MIREGMGR,

Thank you. I got some clue from your response, "...equipment is used on average once daily, and will be down for several days, ..".

May be, I can think of something relevant to our instruments in this line to develop a strategy of reporting the field action (correction/removal).

Many Thanks,
Sreenu
 
C

cff920

#8
If you feel uncertain, write to FDA for clarification. This is the safest way to protect your firm from relevant legal exposure.
 
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