What replaced section 820.100 for corrective and preventive action?

ISO 13485 clause 8.5.2 for corrective action and 8.5.3 for preventive action, incorporated into Part 820 since February 2, 2026. FDA still expects each action verified or validated so it works and does not harm the finished device.

Should I drop a corrective action because its payback is long?

No. A nonconformity with patient risk needs action whatever the payback. FDA expects the action to match the size of the problem and its risk, so a long payback argues for a simpler effective action, not none.

What goes in verification and effectiveness hours?

Everything that proves the action worked: test or validation protocols and reports, data review over the monitoring period, and the effectiveness check sign-off. When the change needs revalidation, this phase can cost more than the change itself.

Where does the yearly nonconformance cost come from?

From nonconformance reports and complaint files for this cause over the last 12 months: scrap and rework at absorbed cost, investigation hours and complaint handling.

MedTech Manufacturing calculator

CAPA Cost Calculator

Find what a corrective action costs to close before its plan goes for approval, and how long the nonconformance it removes takes to repay it. You need hours per phase, a burdened rate, direct spend and the problem's yearly cost.

What this calculator does

What a corrective action costs to close, from root cause through the effectiveness check, and its payback against the nonconformance it removes.

Formula used

Phase cost = investigation, implementation, or verification and effectiveness hours × burdened hourly rate
CAPA cost = investigation cost + implementation cost + verification and effectiveness cost + direct spend
Payback period (months) = CAPA cost ÷ nonconformance cost per year × 12
Total hours = investigation + implementation + verification and effectiveness hours

Inputs explained

Investigation Hours: Root cause work: data review, failure analysis, records and process review.
Implementation Hours: Process or design change, procedure revisions and retraining.
Verification and Effectiveness Hours: Verifying or validating the action, then the effectiveness check.
Burdened Hourly Rate: Blended wage, benefits and overhead of the engineers on the CAPA.
Direct Spend: Purchases for the action: tooling, fixtures, test lab fees, validation samples.
Nonconformance Cost per Year: Scrap, rework and complaint cost this cause created in 12 months.

How to use the result

Best suited to budgeting a corrective action plan before approval, choosing between a procedure fix and a redesign.
Simple payback ignores patient risk: an action on a safety problem is required whatever its payback. Excludes premarket submissions, labeling changes or field actions the change may trigger.

Current U.S. benchmarks

U.S. manufacturing runs at 75.7% of capacity with new factory orders at $663B per month (Federal Reserve and Census, Aug 2026).
The U.S. has 8,825 medical equipment and supplies establishments employing about 308,388 workers (Census County Business Patterns, 2023).

Common questions

What replaced section 820.100 for corrective and preventive action? ISO 13485 clause 8.5.2 for corrective action and 8.5.3 for preventive action, incorporated into Part 820 since February 2, 2026. FDA still expects each action verified or validated so it works and does not harm the finished device.
Should I drop a corrective action because its payback is long? No. A nonconformity with patient risk needs action whatever the payback. FDA expects the action to match the size of the problem and its risk, so a long payback argues for a simpler effective action, not none.
What goes in verification and effectiveness hours? Everything that proves the action worked: test or validation protocols and reports, data review over the monitoring period, and the effectiveness check sign-off. When the change needs revalidation, this phase can cost more than the change itself.
Where does the yearly nonconformance cost come from? From nonconformance reports and complaint files for this cause over the last 12 months: scrap and rework at absorbed cost, investigation hours and complaint handling.

Last reviewed 2026-10-01.