Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring". It provides guidance for industry and FDA staff on labeling and premarket requirements. 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 October 18, 2023 Other (Public Domain) 0 reuses 0 favorites
Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for labeling and premarket requirements for display devices used in diagnostic radiology. 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 September 27, 2022 Other (Public Domain) 0 reuses 0 favorites
Guidance Document: Pre-market Requirements for Medical Device Cybersecurity - Summary From Health Canada π¨π¦ Guidance document is intended to provide advice to manufacturers and regulatory representatives on the practices, responses and mitigation measures, which can improve the cybersecurity of their medical device. 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 19, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on labeling and premarket requirements for saline, silicone gel, and alternative breast implants. 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 September 28, 2020 Other (Public Domain) 0 reuses 0 favorites
Clinical Investigations for Prostate Tissue Ablation Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This is a guidance document for clinical investigations of prostate tissue ablation devices, covering topics like GCP, IDE, and premarket requirements. 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 14, 2020 Other (Public Domain) 0 reuses 0 favorites
Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document titled "Classification of Posterior Cervical Screw Systems" providing guidance for industry and FDA staff on premarket requirements. 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 1, 2020 Other (Public Domain) 0 reuses 0 favorites
Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This is a guidance document by the FDA for pre-clinical and clinical studies on neurothrombectomy devices, focusing on GCP and premarket requirements. 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 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Uniform Contraceptive Labeling - Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for the industry on premarket requirements for uniform contraceptive labeling. 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
Noise Claims in Hearing Aid Labeling - Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Guidance document on labeling of hearing aids, addressing noise claims and premarket requirements for the industry. 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
Labeling for Electronic Anti-Theft Systems: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry on labeling for electronic anti-theft systems, focusing on premarket requirements. 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
Guidance for Dermabrasion Devices - Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Guidance for Industry on Dermabrasion Devices, covering premarket requirements and regulations. 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 18, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance Document For Washers And Washer-Disinfectors Intended For Processing Reusable Medical Devices From Food and Drug Administration (FDA) πΊπΈ A guidance document for washers and washer-disinfectors used in processing reusable medical devices, focusing on premarket requirements. 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
510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants From Food and Drug Administration (FDA) πΊπΈ A guidance document providing information on the premarket requirements for hydroxyapatite coated orthopedic implants. 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
Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip Systems From Food and Drug Administration (FDA) πΊπΈ A guidance document for preparing premarket notifications for ceramic ball hip systems. Focuses on premarket requirements. 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
Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Exercise Equipment From Food and Drug Administration (FDA) πΊπΈ A guidance document for preparing premarket notification applications for exercise equipment, focusing on premarket requirements. 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
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and FDA Staff. Covers premarket requirements. 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 13, 2019 Other (Public Domain) 0 reuses 0 favorites