federal_register: 04-19178

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

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
04-19178 Dental Devices; Dental Noble Metal Alloys and Dental Base Metal Alloys; Designation of Special Controls Rule The Food and Drug Administration is amending the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base alloys devices in order to designate a special control for these devices. FDA is also exempting these devices from premarket notification requirements. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance documents that would serve as special controls for these devices. 2004-08-23 2004 8 https://www.federalregister.gov/documents/2004/08/23/04-19178/dental-devices-dental-noble-metal-alloys-and-dental-base-metal-alloys-designation-of-special https://www.govinfo.gov/content/pkg/FR-2004-08-23/pdf/04-19178.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration is amending the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base alloys devices in order to designate a special control for these devices. FDA is...

Links from other tables