Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on premarket notification submissions for metal expandable biliary stents. 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 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Dental Curing Lights - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for industry and FDA staff on premarket notification (510(k)) submissions for dental curing lights. 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 on July 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A draft guidance document for industry and FDA staff on premarket notification (510(k)) submissions for dental composite resin devices. 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 on July 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-10895. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification. FDA is… 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 May 20, 2024 Other (Public Domain) 0 reuses 0 favorites
Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for the premarket notification submissions of pulse oximeters by the FDA and industry 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 April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for industry and FDA staff on premarket notifications for pediatric X-ray imaging 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 on April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for industry and FDA staff on premarket notification submissions for dental bone grafting material devices in animal studies. 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 on March 28, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of 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 18, 2024 Other (Public Domain) 0 reuses 0 favorites
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document titled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." It focuses on 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 January 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems : Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for the submission of premarket notifications for emission computed tomography devices and nuclear tomography systems. 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 December 13, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-26209. The Food and Drug Administration (FDA, Agency, or we) are proposing to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals (unclassified, preamendments devices) as solid wound dressings; wound dressings… 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 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for the submission of premarket notifications for magnetic resonance diagnostic 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 on October 10, 2023 Other (Public Domain) 0 reuses 0 favorites
Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for industry and FDA staff on using clinical data in premarket notification submissions. 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 on September 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A draft guidance document providing best practices for selecting a predicate device to support a premarket notification submission. 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 on September 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on labeling recommendations for hydrogen peroxide-based contact lens care products. 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 July 26, 2023 Other (Public Domain) 0 reuses 0 favorites
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for the industry and FDA staff on premarket notification submissions for peripheral PTA and specialty catheters. 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 13, 2023 Other (Public Domain) 0 reuses 0 favorites
Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This is a draft guidance document for the premarket notification of orthopedic non-spinal bone plates, screws, and washers. 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 28, 2023 Other (Public Domain) 0 reuses 0 favorites
Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on policy clarification and premarket notification for ultrasonic diathermy 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 on February 21, 2023 Other (Public Domain) 0 reuses 0 favorites
Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a draft guidance for the industry and FDA staff on premarket notification submissions for Photobiomodulation (PBM) 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 on January 11, 2023 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-23868. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, postamendments class III devices with the product code MZF, into class II (special controls), subject 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 November 4, 2022 Other (Public Domain) 0 reuses 0 favorites