Medical Device Reporting Guidance Documents

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Medical Device Reporting for Manufacturers | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-reporting-manufacturers

Center for Devices and Radiological Health This guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses reporting and...

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB) For Questions about Medical Device Reporting, including interpretation of MDR policy: …

Recent Final Medical Device Guidance Documents | FDA

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

Jan 12, 2023

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. …

Medical Device Reporting for Manufacturers …

https://www.fda.gov/media/86420/download

Medical Device Reporting for Manufacturers . Guidance for Industry and Food and Drug Administration Staff . Document issued on: November 8, 2016 . The draft of this …

Medical Device Reporting for Manufacturers; Guidance …

https://www.federalregister.gov/documents/2016/11/08/2016-26933/medical-device-reporting-for-manufacturers-guidance-for-industry-and-food-and-drug-administration

Medical device reporting under section 519 (a) of the Federal Food Drug, and Cosmetic Act ( 21 U.S.C. 360i (a)) provides a mechanism that allows FDA and …

Incident reporting for medical devices: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

One of the study groups within the GHTF has produced a document entitled " Medical Devices Post Market Surveillance: Global Guidance for Adverse …

Guidance - MDCG endorsed documents and other guidance

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro …

Australian regulatory guidelines for medical devices …

https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical …

MDCG 2023-3 Questions and Answers on vigilance terms …

https://health.ec.europa.eu/system/files/2023-02/mdcg_2023-3_en_0.pdf

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of …

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