About the Author
Proxima CRO Team
Taylor Lunsford, MGA
Regulatory Associate II
Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.

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.

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