federal_register: 2011-18806

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-18806 Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic Stimulation System Rule The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices. 2011-07-26 2011 7 https://www.federalregister.gov/documents/2011/07/26/2011-18806/medical-devices-neurological-devices-classification-of-repetitive-transcranial-magnetic-stimulation https://www.govinfo.gov/content/pkg/FR-2011-07-26/pdf/2011-18806.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the repetitive transcranial magnetic stimulation (rTMS) system into class II (special controls). The Agency is classifying this device type into class II (special controls) in order to provide a...

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