RegDesk Regulatory Roundup

Dec 19, 2023

FDA Guidance on General Considerations for Animal Studies: Specific Aspects

The new article highlights the aspects related to the way animal studies should be planned and conducted, including the facility selection, as well as keeping animals during the study

FDA Guidance on Considerations for Weight Loss Devices: Benefit-Risk Assessment

Oct 31, 2023

FDA

FDA Guidance on Considerations for Weight Loss Devices: Benefit-Risk Assessment

The article provides a general overview of the existing regulatory framework associated with adverse events.

FDA Guidance on Considerations for Weight Loss Devices: Study Design, Duration, and Follow-Up

Oct 20, 2023

FDA

FDA Guidance on Considerations for Weight Loss Devices: Study Design, Duration, and Follow-Up

The article provides an overview of the new regulation and highlights the key points associated thereto.

A Comparative Analysis of Medical Device Adverse Event Reporting Regulations in the EU and US

Oct 12, 2023

CDRH

A Comparative Analysis of Medical Device Adverse Event Reporting Regulations in the EU and US

This article highlights the details of the adverse event reporting regulations in the European Union (EU) and the United States (US), their similarities, differences, and their impact on medical device safety. Table of Contents Ensuring the safety and effectiveness of...

Understanding FDA Registered vs Cleared vs Approved vs Granted for Medical Devices

Oct 11, 2023

CDRH

Understanding FDA Registered vs Cleared vs Approved vs Granted for Medical Devices

This article highlights the critical differences between FDA registration, clearance, approval, and granting for medical devices, offering essential insights for manufacturers and healthcare professionals navigating the regulatory landscape Table of Contents In the...

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