Frequently Asked Questions

What happens if there are corrections and removals to a medical device, according to CAPA?

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Guidelines & Standards
Compliance & Regulatory: MedTech
FDA Clearance

According to the FDA, under 21 CFR 806, Medical Devices; Reports of Corrections and Removals, manufacturers and importers are required to make a report to the FDA of any correction or removal of a medical device(s). This is done if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health.