federal_register: 03-6646

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
03-6646 General and Plastic Surgery Devices; Classification of Silicone Sheeting Proposed Rule The Food and Drug Administration (FDA) is proposing to classify silicone sheeting intended to manage hyperproliferative (hypertrophic and keloid) scars on intact skin into class I (general controls) and to exempt the device from premarket notification. The agency is publishing the recommendation of the General and Plastic Surgery 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 that will provide reasonable assurance of the safety and effectiveness of this device. This action is taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Devices User Fee Modernization Act (MDUFMA). 2003-03-20 2003 3 https://www.federalregister.gov/documents/2003/03/20/03-6646/general-and-plastic-surgery-devices-classification-of-silicone-sheeting https://www.govinfo.gov/content/pkg/FR-2003-03-20/pdf/03-6646.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to classify silicone sheeting intended to manage hyperproliferative (hypertrophic and keloid) scars on intact skin into class I (general controls) and to exempt the device from premarket notification....  

Links from other tables