Medical Device Final Report

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

Voluntary Medical Device Reporting The FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse …

IDE Reports | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-reports

eCFR :: 21 CFR Part 803 -- Medical Device Reporting

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device …

IDE Responsibilities | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-responsibilities

A sponsor is responsible for selecting investigators qualified by training and experience to investigate the device. Selecting Monitors (§812.43) A sponsor must select …

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

Component and Device Documentation Examples

https://www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/component-and-device-documentation-examples-test-articles-or-previously-marketed-devices

Details to support claim: “The information provided to support a claim that processing and sterilization changes will not affect chemical or physical properties of the …

Attachment C: Summary of MDR Reporting …

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/attachment-c-summary-mdr-reporting-requirements

Firms now have up to 30 CALENDAR days after they become aware of a device related death, serious injury or malfunction before they are required to submit a …

FDA Medical Device Inspections - Food and Drug …

https://www.fda.gov/media/94076/download

An FDA validated method for investigators to conduct medical device inspections. Uses the “top down” approach –look at procedures and ask questions -then review records …

Writing Great Medical Device Audit Reports …

https://www.orielstat.com/blog/writing-great-medical-device-audit-reports/

Medical Device Audit Report Contents and Format The nature of your audit should determine the length, format, emphasis, and sequence. Audit reports should be …