Medical Device Tracking Guidance Industry

Medical Device Tracking | FDA

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

FDA is issuing this guidance to announce that both the list of devices subject to medical device tracking requirements, and the list of medical devices released from tracking...

Medical Device Tracking | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/medical-device-tracking

Manufacturers of a tracked device must establish a written standard operating procedure (SOP) which includes a method for tracking the device throughout distribution and a …

Medical Device Tracking : Guidance for Industry and …

https://www.hhs.gov/guidance/document/medical-device-tracking-guidance-industry-and-fda-staff

Medical Device Tracking : Guidance for Industry and FDA Staff. DISCLAIMER: The contents of this database lack the force and effect of law, except as …

Medical Device Tracking; Guidance for Industry and FDA Staff

https://www.reginfo.gov/public/do/DownloadDocument?objectID=28670901

Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. This revised guidance …

FDA Modernization Act of 1997; Guidance on Medical …

https://www.federalregister.gov/documents/2000/01/24/00-1542/fda-modernization-act-of-1997-guidance-on-medical-device-tracking-availability

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=821

§ 821.4 - Imported devices. Subpart B - Tracking Requirements § 821.20 - Devices subject to tracking. § 821.25 - Device tracking system and content …

FDA Medical Device Tracking - ECA Academy - gmp …

https://www.gmp-compliance.org/guidelines/gmp-guideline/fda-medical-device-tracking

FDA Medical Device Tracking Internet: https://www.gmp-compliance.org/files/guidemgr/Medical-Device-Tracking---Guidance-for-Industry-and …

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 …

Federal Register :: Medical Devices; Device Tracking

https://www.federalregister.gov/documents/2000/04/25/00-10251/medical-devices-device-tracking

C. Tracking Guidance Documents and FDA Reconsideration, Rescission, and Additional Issuance of Tracking Orders . In the March 4, 1998, Federal Register, …

Australian regulatory guidelines for medical devices …

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

Meet safety, performance and quality requirements for medical device manufacturers (The Essential Principles) Principle 1 - Use of medical devices not to …