federal_register: 2017-23516

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2017-23516 Medical Devices; Neurological Devices; Classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System Rule The Food and Drug Administration (FDA or we) is classifying the non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system 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 non-EEG physiological signal based seizure monitoring system'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. 2017-10-30 2017 10 https://www.federalregister.gov/documents/2017/10/30/2017-23516/medical-devices-neurological-devices-classification-of-the-non-electroencephalogram-physiological https://www.govinfo.gov/content/pkg/FR-2017-10-30/pdf/2017-23516.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or we) is classifying the non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system into class II (special controls). The special controls that apply to the device type are identified...

Links from other tables