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Similarly, over-the-counter tests to detect SARS-CoV-2, diabetes digital behavioral therapeutic devices, prognostic tests to assess chronic kidney disease progression, non-medicated topical formulations to treat erectile dysfunction, and active noise attenuation systems for infant incubators were also classified as class II devices with special controls

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In summary, for the CY 2026 OPPS, we proposed to maintain the current 5 level structure for the Neurostimulator and Related Procedure APC series