Infusion Pump - Pre-Clearance Inspections Learnings

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

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.

Hope you have gone through recent inspection observations and warning letters on infusion pumps.
apart from system compliance (part 820, 13485 or 14971), I would like to emphasize the design verification & control strategy.

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.

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

Best Regards,
Pooja