Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ Guidance document outlining appeal options for mammography facilities regarding adverse accreditation decisions, certificate suspension/revocation, and notification orders. Administrative/procedural focus. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 1 week ago Other (Public Domain) 0 reuses 0 favorites
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance document titled "Center for Devices and Radiological Health (CDRH) Appeals Processes" that provides information about 517A and is relevant to administrative/procedural and premarket topics. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 10, 2023 Other (Public Domain) 0 reuses 0 favorites
Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance on the appeals processes of the Center for Devices and Radiological Health (CDRH) for industry and FDA staff. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 10, 2023 Other (Public Domain) 0 reuses 0 favorites
Presiding Officer for an Appeal and Informal Hearing; Technical Amendments From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2017-05350. The Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the dissolution of the Regional Food and Drug Directorโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 17, 2017 Other (Public Domain) 0 reuses 0 favorites
Guide to Refusals and Appeals From Health Products Regulatory Authority (HPRA) ๐ฎ๐ช A document providing guidance on refusals and appeals. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures From Food and Drug Administration (FDA) ๐บ๐ธ Document number 01-1128. The Food and Drug Administration (FDA) is proposing regulations under which FDA may rescind a decision issued under the Federal Food, Drug, and Cosmetic Act (the act) that a device is substantially equivalent to a legally marketed device, and, therefore, may be marketed.โฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 16, 2001 Other (Public Domain) 0 reuses 0 favorites