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Comment: A commenter expressed concern that limiting survey administration to email and text communications may affect representativeness and data quality because patients who have limited internet access may not be included in the survey

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In addition to the criteria at 419.66(b)(1) through (4), the criteria for establishing new device categories are specified at 419.66(c)

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Jamie & Phil Newcomb Phil and I first met in 2015 while working as nurses at Nebraska Medicine