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federal_register: 2019-23304

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2019-23304 Medical Devices; Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic Massager Rule The Food and Drug Administration (FDA or we) is classifying the internal therapeutic massager into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the internal therapeutic massager's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. 2019-10-25 2019 10 https://www.federalregister.gov/documents/2019/10/25/2019-23304/medical-devices-physical-medicine-therapeutic-devices-classification-of-the-internal-therapeutic https://www.govinfo.gov/content/pkg/FR-2019-10-25/pdf/2019-23304.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or we) is classifying the internal therapeutic massager into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language...

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