federal_register: 02-26816

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
02-26816 Neurological Devices; Classification of Human Dura Mater Proposed Rule The Food and Drug Administration (FDA) is proposing to classify human dura mater intended to repair defects in human dura mater into class II (special controls). The agency is publishing the recommendations of FDA's Neurological Devices Panel (the Panel) regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device. This action is being taken to establish sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that FDA intends to serve as the special control for this device. 2002-10-22 2002 10 https://www.federalregister.gov/documents/2002/10/22/02-26816/neurological-devices-classification-of-human-dura-mater https://www.govinfo.gov/content/pkg/FR-2002-10-22/pdf/02-26816.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to classify human dura mater intended to repair defects in human dura mater into class II (special controls). The agency is publishing the recommendations of FDA's Neurological Devices Panel (the...

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