21 CFR Chapter I Subchapter H β Medical Devices β Part 801 Labeling From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 801 Labeling". 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 884 Obstetrical and Gynecological Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 884 Obstetrical and Gynecological Devices". 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
CPG Sec. 345.100 Condoms; Defects - Criteria for Direct Reference Seizure From Food and Drug Administration (FDA) πΊπΈ This document is a Compliance Policy Guide (CPG) titled "CPG Sec. 345.100 Condoms; Defects - Criteria for Direct Reference Seizure". It falls under the topic of "Administrative / Procedural". 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 3, 2021 Other (Public Domain) 0 reuses 0 favorites
Surveillance and Detention Without Physical Examination of Condoms: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on surveillance and detention without physical examination of condoms. 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 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions: Guidance for Industry". It falls under the topic of "Premarket". 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
Testing Guidance for Male Condoms Made From New Material (Non-Latex) From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for premarket testing of male condoms made from non-latex material. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom Products From Food and Drug Administration (FDA) πΊπΈ This document is a guidance letter for manufacturers, distributors, and importers of condom products, covering postmarket 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 March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom From Food and Drug Administration (FDA) πΊπΈ Document number 2018-21044. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single-use female condoms, renaming the device to "single-use internal condom," a postamendments class III device (regulated under product code MBU), into class II (specialβ¦ 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 27, 2018 Other (Public Domain) 0 reuses 0 favorites
Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom From Food and Drug Administration (FDA) πΊπΈ Document number 2017-26011. The Food and Drug Administration (FDA) is proposing to reclassify single-use female condoms, renaming the device to "single- use internal condom," a postamendments class III device (product code MBU), into class II (special controls) subject to premarket notificationβ¦ 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 4, 2017 Other (Public Domain) 0 reuses 0 favorites
Notice of the Food and Drug Administration on Strengthening Condom Quality and Safety Management From National Medical Products Administration (NMPA) π¨π³ FGWJ-2015-10345 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
General Office of the Food and Drug Administration on the implementation of condom export record management notice From National Medical Products Administration (NMPA) π¨π³ FGWJ-2013-10308 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices From Food and Drug Administration (FDA) πΊπΈ Document number 2011-20664. 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 following three class III preamendments devices: Ventricular bypassβ¦ 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 16, 2011 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices From Food and Drug Administration (FDA) πΊπΈ Document number 2010-21142. The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following four class III preamendments devices: Ventricular bypass (assist)β¦ 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 25, 2010 Other (Public Domain) 0 reuses 0 favorites
On the investigation and handling of supervision and sampling tests failed imported condoms letter sampling tests failed imported condoms letter From National Medical Products Administration (NMPA) π¨π³ FGWJ-2010-10049 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 2, 2010 Other (Public Domain) 0 reuses 0 favorites
Letter on investigation and handling of counterfeit imported condoms From National Medical Products Administration (NMPA) π¨π³ FGWJ-2010-10048 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 2, 2010 Other (Public Domain) 0 reuses 0 favorites
On the accreditation of Zhuzhou Chemical Industry Latex Products Quality Supervision and Inspection Center for natural latex rubber condom product testing qualifications notice From National Medical Products Administration (NMPA) π¨π³ FGWJ-2009-10322 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on August 24, 2009 Other (Public Domain) 0 reuses 0 favorites
Notice on the Accreditation of the National Population and Family Planning Commission's Pharmaceutical Quality Monitoring Center for Testing Natural Latex Rubber Condom Products From National Medical Products Administration (NMPA) π¨π³ FGWJ-2009-10323 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on August 24, 2009 Other (Public Domain) 0 reuses 0 favorites
On the natural latex rubber condom production quality system special inspection notice From National Medical Products Administration (NMPA) π¨π³ FGWJ-2009-10306 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on August 11, 2009 Other (Public Domain) 0 reuses 0 favorites
Notice on filling in the natural latex rubber condom production enterprise situation questionnaire From National Medical Products Administration (NMPA) π¨π³ FGWJ-2009-10173 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
On the natural latex rubber condom product quality supervision and testing results of the circular From National Medical Products Administration (NMPA) π¨π³ FGWJ-2006-10195 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on September 20, 2006 Other (Public Domain) 0 reuses 0 favorites