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Nature 304 , 368371 (1983)
The applicant and commenter stated that the criteria to apply an existing category to a new device, as stated in 419.66(f)(2), requires that the new device conforms to CMS guidance relating to the definition of terms and other information in conjunction with the category descriptors and codes
and (vi) for female patients, no pregnancy/lactation
Medical supervision ensures appropriate dosing protocols, monitoring for digestive improvement, and integration with comprehensive wellness strategies that address the root causes of gastrointestinal dysfunction and support overall healing capacity
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