Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document for industry and FDA staff on premarket notification submissions for dental bone grafting material devices in animal studies.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
General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document for industry and FDA staff on conducting animal studies to evaluate medical devices, covering 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 March 27, 2023 Other (Public Domain) 0 reuses 0 favorites
Utilizing Animal Studies to Evaluate Organ Preservation Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on using animal studies to evaluate organ preservation devices in premarket stage. 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 7, 2019 Other (Public Domain) 0 reuses 0 favorites