21 CFR Chapter I Subchapter H – Medical Devices – Part 830 Unique Device Identification From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 830 Unique Device Identification". 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
21 CFR Chapter I Subchapter H – Medical Devices – Part 806 Medical Devices; Reports of Corrections and Removals From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "Medical Devices; Reports of Corrections and Removals" 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 March 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Product Recalls, Including Removals and Corrections: Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 A guidance document for the industry on product recalls, including removals and corrections, with a focus on recalls. 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 April 16, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Technical Amendment From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-06139. The Food and Drug Administration (FDA or Agency) is amending the medical device reports of corrections and removals regulation to correct three inaccurate cross-references. This action is editorial in nature and is intended to improve the accuracy of the Agency's… 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 1, 2019 Other (Public Domain) 0 reuses 0 favorites
GN-10-R3.1 Guidance on Medical Device Field Safety Corrective Action (Updated on January 2019) From Health Sciences Authority (HSA) 🇸🇬 Provides guidance on Medical Device Field Safety Corrective Action (FSCA). 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 January 1, 2019 Other (Public Domain) 0 reuses 0 favorites
Physical Medicine Devices; Reclassification of Shortwave Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal Shortwave Therapy From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-25923. The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device "nonthermal shortwave therapy" (SWT). FDA is also… 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 13, 2015 Other (Public Domain) 0 reuses 0 favorites
Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-03594. The Food and Drug Administration (FDA) is proposing to reclassify the shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device "nonthermal shortwave therapy (SWT)." FDA is proposing 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 February 20, 2014 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Reports of Corrections and Removals; Technical Amendment From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-03581. The Food and Drug Administration (FDA) is amending its regulation regarding reports of corrections to and removals of medical devices to address a minor change as a result of the enactment of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This action… 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, 2014 Other (Public Domain) 0 reuses 0 favorites
Administrative Detention; Corrections From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-03582. The Food and Drug Administration (FDA) published a document in the Federal Register on Friday, March 9, 1979 (44 FR 13239). The document established administrative detention procedures for devices intended for human use believed to be adulterated or misbranded. 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 February 19, 2014 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
Order of March 15, 2010 establishing the terms of application of the conformity certification procedures defined in articles R. 5211-39 to R. 5211-52, taken in application of article R. 5211-53 of the public health code (correction) From Ministry of Labor, Health and Solidarity (MTSS) 🇫🇷 Document NOR : SASP1006025Z – Arrêté du 15 mars 2010 fixant les modalités d'application des procédures de certification de la conformité définies aux articles R. 5211-39 à R. 5211-52, pris en application de l'article R. 5211-53 du code de la santé publique (rectificatif) 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 15, 2010 Other (Public Domain) 0 reuses 0 favorites
Order of September 13, 2005 concerning the detailed specifications specifying the essential requirements with which medical devices manufactured from tissues of animal origin must comply (correction) From Ministry of Labor, Health and Solidarity (MTSS) 🇫🇷 Document NOR : SANP0522988Z – Arrêté du 13 septembre 2005 relatif aux spécifications détaillées précisant les exigences essentielles auxquelles doivent se conformer les dispositifs médicaux fabriqués à partir de tissus d'origine animale (rectificatif) 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 13, 2005 Other (Public Domain) 0 reuses 0 favorites