Guidance Documents Medical Devices And Radiation-Emitting Products

Guidance Documents (Medical Devices and Radiation …

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. …

Radiation-Emitting Products Guidance | FDA

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/radiation-emitting-products-guidance

Device Advice: Comprehensive Regulatory Assistance Guidance Documents (Medical Devices and Radiation-Emitting Products) Radiation-Emitting Products Guidance …

CDRH Proposed Guidances for Fiscal Year 2023 …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2023-fy2023

Class II Special Controls Documents | FDA

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents

Class II Special Controls Documents This page lists special controls …

Device Advice: Comprehensive Regulatory Assistance

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

Guidance Documents (Medical Devices and Radiation-Emitting Products) Data Standards and Terminology Standards for Information Submitted to CDRH Reprocessing …

CDRH Proposed Guidance Development | FDA

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development

Guidance Documents (Medical Devices and Radiation-Emitting Products) CDRH Proposed Guidance Development CDRH Proposed Guidance …

Sunglasses, Spectacle Frames, Spectacle Lens and …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/sunglasses-spectacle-frames-spectacle-lens-and-magnifying-spectacles

Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices …

Implantable Radiofrequency Transponder System for …

https://cacmap.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/implantable-radiofrequency-transponder-system-patient-identification-and-health-information-class-ii

This guidance document was developed as a special control guidance to support the classification of the implantable radiofrequency transponder system for …

Vascular Prostheses 510(k) Submissions Guidance

https://cacmap.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/vascular-prostheses-510k-submissions-guidance-industry-and-fda-staff

QSR issues of particular significance to manufacturers of permanently implantable medical devices, such as vascular grafts, include but are not limited to the following: Overall …