Evidence Requirements For Medical Devices

Overview of Regulatory Requirements: Medical Devices

https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

FDA has classified all medical devices into either Class I, II, and III. Currently, in the Code of Federal Regulations, there are about 1700 devices that have been classified by the FDA. They...

Real-World Evidence to Support Regulatory Decision …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices

Center for Devices and Radiological Health FDA is issuing this guidance to clarify how we evaluate real-world data to determine whether they are sufficient for generating the types …

Guidance on clinical evidence requirements for medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/clinical-evidence-requirements-medical-devices.html

Examples of clinical evidence requirements for medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/clinical-evidence-requirements-medical-devices/examples.html

Detailed examples relating to a variety of medical devices have been provided to enhance understanding. The Guidance on clinical evidence requirements …

Guidance on clinical evidence requirements for medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/clinical-evidence-requirements-medical-devices/clinical-data-evaluation.html

The IEC 62366-1 international standard on medical devices - Part 1: Application of usability engineering to medical devices defines a usability test as a …

Do you have sufficient clinical evidence for your medical …

https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/do-you-have-sufficient-clinical-evidence-for-your-medical-device2/

Special attention is given to class III and implantable devices that are exempt from the requirement to conduct a clinical investigation because they have been previously CE-marked under the Directives or …

Guidance on clinical evidence requirements for medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/clinical-evidence-requirements-medical-devices/comparator-devices.html

The need for a device-specific clinical investigation may depend on the ability of the existing evidence to: address the device's benefit/risk profile and …

Guidance on clinical evidence requirements for medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/clinical-evidence-requirements-medical-devices/submitting-clinical-evidence.html

Device-specific clinical evidence may be required for the following: novel technologies less established technologies new safety or effectiveness issues with …

Health Canada Issues Final Guidance on Clinical …

https://www.emergobyul.com/news/health-canada-issues-final-guidance-clinical-evidence-requirements-medical-devices

Health Canada Issues Final Guidance on Clinical Evidence Requirements for Medical Devices. December 5, 2022. Health Canada has finalized the Guidance on Clinical Evidence Requirements for …

"Sufficient clinical evidence" requirements increasing under the ...

https://www.emergobyul.com/news/understanding-sufficient-clinical-evidence-requirements-under-european-medical-devices

The European Medical Devices Regulation (MDR) demands that “ confirmation of conformity with relevant general safety and performance requirements …