federal_register: E8-12120

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 regulation_id_numbers
E8-12120 Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System Proposed Rule The Food and Drug Administration (FDA) is proposing to reclassify the full field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce full field digital x-ray images of the breast. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document entitled "Class II Special Controls Guidance Document: Full Field Digital Mammography System" that would serve as the special control for the device, if FDA reclassifies this device type. 2008-05-30 2008 5 https://www.federalregister.gov/documents/2008/05/30/E8-12120/medical-devices-radiology-devices-reclassification-of-full-field-digital-mammography-system https://www.govinfo.gov/content/pkg/FR-2008-05-30/pdf/E8-12120.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to reclassify the full field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce full field digital x-ray...  

Links from other tables