FDA Unable to Conduct Medical Device Inspections in China

The FDA is unable to conduct medical device plant inspections in China because of the U.S. State Dept.’s travel advisory amid the Coronavirus outbreak

While the FDA is unable to conduct inspections, it plans to rely on tools such as import screening, examinations, sampling and import alerts, along with information from foreign governments, to monitor FDA-regulated products that enter the country.

More than 60% of FDA-regulated products imported from China are medical devices, with a further 20% coming in the form of housewares, such as food packaging.

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