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Statement from FDA for Devices and Radiological Health, on FDA’s updates to Medical Device Safety A
date:Nov 21, 2018
an 18,000 firms in more than 21,000 medical device facilities worldwide. These products provide immense and often life-saving benefits to millions of patients. On average, we approve, clear or grant marketing authorization to approximately 12 new or modified devices every business day after carefully determining -- based on valid scientific evidence -- that the devices are safe and effective. These decisions take into consideration whether the benefits of the devices outweigh their risks to pati

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