Infusion Pump - Pre-Clearance Inspections Learnings

A

Aaria

#1
#1
While the overall requirement is 820 compliance, what are the most critical elements to be addressed for preparing towards pre-clearance inspection, in particular, for infusion pumps? If anyone can share lessons learned from such pre-clearance inspection, it will be very helpful.

Thanks,
Aaria
 
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Y

yodon

Leader
Super Moderator
#2
#2
Risk, risk, risk. Ensure that risk analysis is thorough. There are many, many cases of adverse events reported so the FDA knows the risks associated with infusion pumps and if you haven't identified and mitigated them, you will have issues.

At one point, the FDA had said they were going to require safety / assurance case analysis. I don't know if they ever enforced that or not.
 
Ronen E

Ronen E

Problem Solver
Moderator
#4
#4
No doubt that warning letters are a rich source of information for any and all infusion pump manufacturers. Study them well and get prepared.

Cheers,
Ronen.
 
A

Aaria

#5
#5
Great inputs, thanks. I've been preparing a summary document which captures industry experiences through warning letters/inspection observations.

Best Regards,
Pooja
 
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