federal_register: E7-7702

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
E7-7702 Medical Devices; Obstetrical and Gynecological Devices; Classification of Computerized Labor Monitoring System Rule The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems," which will serve as the special controls for these devices. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices. 2007-04-24 2007 4 https://www.federalregister.gov/documents/2007/04/24/E7-7702/medical-devices-obstetrical-and-gynecological-devices-classification-of-computerized-labor https://www.govinfo.gov/content/pkg/FR-2007-04-24/pdf/E7-7702.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled,...  

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