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The FDA may start accepting real-world evidence in support of device applications, but sponsors need to identify the sources of real-world evidence they’re using in advance, the agency said. Read More
Last month, the FDA threatened to take regulatory action against the devicemakers after analyses found that the contamination rates have increased. Read More
The FDA has finalized a list of accessories that can be classified as Class 1 devices. The listing was required under the FDA Reauthorization Act of 2017. Read More