Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on early collaboration meetings under the FDA Modernization Act, focusing on IDE 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 August 10, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Device De Novo Classification Process From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-21677. The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This final rule establishes procedures and criteria related to… 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 5, 2021 Other (Public Domain) 0 reuses 0 favorites
Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 - Guidance for Industry and for FDA Reviewers From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for industry and FDA reviewers on Section 216 of the FDA Modernization Act of 1997. 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 18, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document on validation data for reprocessed single-use medical devices under the Medical Device User Fee and Modernization Act of 2002. 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 February 28, 2020 Other (Public Domain) 0 reuses 0 favorites
Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for manufacturers on labeling requirements for single-use medical devices to comply with the Medical Device User Fee and Modernization Act. 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 February 28, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Device De Novo Classification Process From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-26378. The Food and Drug Administration (FDA) proposes to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The proposed requirements establish procedures and criteria related to requests 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 December 7, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Device Reporting: Electronic Submission Requirements From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-03279. The Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events,… 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 14, 2014 Other (Public Domain) 0 reuses 0 favorites
Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007 From Food and Drug Administration (FDA) 🇺🇸 Document number 2012-18764. The Food and Drug Administration (FDA) is amending its regulations to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007… 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, 2012 Other (Public Domain) 0 reuses 0 favorites
Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices From Food and Drug Administration (FDA) 🇺🇸 Document number 2012-15024. The Food and Drug Administration (FDA) is proposing to reclassify the implanted blood access device preamendments class III device into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this… 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 20, 2012 Other (Public Domain) 0 reuses 0 favorites
Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-26625. The Food and Drug Administration (FDA) is proposing to reclassify the external pacemaker pulse generator preamendments class III device into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking… 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 17, 2011 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-9899. The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than… 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 April 25, 2011 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
Dental Products Devices; Reclassification of Endosseous Dental Implant Accessories From Food and Drug Administration (FDA) 🇺🇸 Document number 00-25811. The Food and Drug Administration (FDA) is reclassifying the manually powered drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, trial abutments, and other manually powered endosseous… 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 10, 2000 Other (Public Domain) 0 reuses 0 favorites
Gastroenterology and Urology Devices; Effective Date of Requirement for Premarket Approval of the Implanted Mechanical/Hydraulic Urinary Continence Device From Food and Drug Administration (FDA) 🇺🇸 Document number 00-24632. The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the implanted mechanical/hydraulic urinary continence device, a generic… 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 September 26, 2000 Other (Public Domain) 0 reuses 0 favorites
Administrative Practices and Procedures; Good Guidance Practices From Food and Drug Administration (FDA) 🇺🇸 Document number 00-23887. The Food and Drug Administration (FDA) is amending its administrative regulations to codify its policies and procedures for the development, issuance, and use of guidance documents. This action is necessary to comply with requirements of the Food and Drug Administration… 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 September 19, 2000 Other (Public Domain) 0 reuses 0 favorites