Guidance for Industry: Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses From Food and Drug Administration (FDA) 🇺🇸 A guidance document providing instructions for submitting a color additive petition for contact lenses to the Center for Food Safety and Applied Nutrition. 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices From Food and Drug Administration (FDA) 🇺🇸 This document provides FDA recommendations for submitting chemical and technological data on color additives for food, drugs, cosmetics, or medical devices. 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
Normative Instruction - IN no. 290 of 04/04/2024 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Establishes, under the terms of Collegiate Board Resolution - RDC No. 741, of August 10, 2022, an optimized procedure for the analysis and decision of medical device registration petitions, through the use of analyses carried out by an Equivalent Foreign Regulatory Authority (AREE). Metadata quality: Metadata quality: Data description filled Files documented 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: 66.66666666666666/100 Updated on April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 860 Medical Device Classification Procedures From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "Medical Device Classification Procedures" under 21 CFR Chapter I Subchapter H. Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated on July 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Color Additive Petitions - Medical Devices From Food and Drug Administration (FDA) 🇺🇸 A guidance document titled "Color Additive Petitions - Medical Devices" for reference and information. 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 March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-00295. The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification (510(k)) requirements for powered wheeled stretchers (product code INK). These devices are battery-powered tables with wheels… 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 14, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-05116. The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of material, such as a… 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 14, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-29633. The Food and Drug Administration (FDA or the Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for electric positioning chair devices. An electric positioning chair is a device with a motorized positioning… 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 November 20, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Device Classification Procedures; Reclassification Petition: Content and Form; Technical Amendment From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-30141. The Food and Drug Administration (FDA) is amending its regulations for petitioning for device reclassification to update mailing addresses for the petitions. This action is being taken to improve the accuracy of the regulations. 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 December 24, 2014 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-04899. The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for wheelchair elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are used… 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 4, 2013 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-04897. The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from premarket notification requirements for powered patient transport devices commonly known as stairway chair lifts. These devices are used to assist in the transfer… 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 4, 2013 Other (Public Domain) 0 reuses 0 favorites
Reporting Information Regarding Falsification of Data From Food and Drug Administration (FDA) 🇺🇸 Document number 2010-3123. The Food and Drug Administration (FDA) is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of… 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 February 19, 2010 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Obstetrical and Gynecological Devices; Classification of the Breast Lesion Documentation System From Food and Drug Administration (FDA) 🇺🇸 Document number 03-19029. The Food and Drug Administration (FDA) is classifying the breast lesion documentation system into class II (special controls). The special controls that will apply to this device are discussed later in this document. The agency is taking this action in response to a… 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 July 28, 2003 Other (Public Domain) 0 reuses 0 favorites
Hematology and Pathology Devices; Reclassification of the Automated Differential Cell Counter From Food and Drug Administration (FDA) 🇺🇸 Document number 02-792. The Food and Drug Administration (FDA) is reclassifying the automated differential cell counter (ADCC) from class III (premarket approval) into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document:… 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 14, 2002 Other (Public Domain) 0 reuses 0 favorites
Clinical Chemistry and Clinical Toxicology Devices; Classification of B-Type Natriuretic Peptide Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 01-4847. The Food and Drug Administration (FDA) is classifying the B- type natriuretic peptide (BNP) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Control Guidance Document for… 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 February 28, 2001 Other (Public Domain) 0 reuses 0 favorites
Medical Device; Exemption From Premarket Notification; Class II Devices; Barium Enema Retention Catheters and Tips With or Without a Bag From Food and Drug Administration (FDA) 🇺🇸 Document number 00-31292. The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for barium enema retention catheters and tips with or without a bag with certain limitations. This rule will exempt from… 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 December 8, 2000 Other (Public Domain) 0 reuses 0 favorites
Immunology and Microbiology Devices; Classification of Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Test Systems From Food and Drug Administration (FDA) 🇺🇸 Document number 00-29841. The Food and Drug Administration (FDA) is classifying the Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Guidance for Industry… 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 November 22, 2000 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Exemption From Premarket Notification; Class II Devices; Triiodothyronine Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 00-26740. The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for the triiodothyronine test system with certain limitations. This rule will exempt from premarket notification the… 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 October 18, 2000 Other (Public Domain) 0 reuses 0 favorites
Obstetrical and Gynecological Devices; Classification of the Clitoral Engorgement Device From Food and Drug Administration (FDA) 🇺🇸 Document number 00-19489. The Food and Drug Administration (FDA) is classifying the clitoral engorgement device into class II (special controls). The special control that will apply is a guidance document entitled: "Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance… 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 August 2, 2000 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Anesthesiology Devices; Classification of Devices to Relieve Upper Airway Obstruction From Food and Drug Administration (FDA) 🇺🇸 Document number 00-15864. The Food and Drug Administration (FDA) is classifying devices to relieve upper airway obstruction into class II (special controls). The special control that will apply to this device is a labeling and design control guidance document. This action is being taken in… 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 June 23, 2000 Other (Public Domain) 0 reuses 0 favorites