federal_register: 03-31174

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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
03-31174 Neurological Devices; Classification of Human Dura Mater Rule The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Class II Special Controls Guidance Document: Human Dura Mater" that will serve as the special control for this device. 2003-12-18 2003 12 https://www.federalregister.gov/documents/2003/12/18/03-31174/neurological-devices-classification-of-human-dura-mater https://www.govinfo.gov/content/pkg/FR-2003-12-18/pdf/03-31174.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable...  

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