United States Medical Device Regulations

Oct 10, 2023

Global Medical Device UDI Requirements: A Quick Reference Guide for United States, Europe, Canada, Japan & Australia

This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across various countries. Table of Contents The use of medical devices is essential in healthcare, with millions of devices being used...

Streamlining Medical Device Development: Investigational Device Exemptions and 21 CFR 812

Oct 6, 2023

CDRH

Streamlining Medical Device Development: Investigational Device Exemptions and 21 CFR 812

This article highlights the key elements of 21 CFR 812, Investigational Device Exemptions and their impact on the medical device industry. Table of Contents The FDA oversees the regulation of medical devices in the United States to ensure their safety and...

Understanding Electronic Records and Signatures: An Overview of 21 CFR Part 11

Oct 5, 2023

FDA

Understanding Electronic Records and Signatures: An Overview of 21 CFR Part 11

This article highlights 21 CFR part 11, its scope, applicability and effective ways to maintain regulatory compliance. Table of Contents 21 CFR Part 11 is a regulation introduced by the United States Food and Drug Administration (FDA) that sets forth the criteria...

Oct 4, 2023

CDRH

Voluntary FDA eSTAR Program

This article highlights the procedure, key points and Benefits of the USFDA eSTAR Submission Programme. Table of Contents eSTAR Submission According to the FDA announcement in September, businesses can now submit premarket applications electronically via the CDRH...

Decoding the USFDA Medical Device Approval Timeline

Oct 4, 2023

CDRH

Decoding the USFDA Medical Device Approval Timeline

This article talks about USFDA Medical Device Approval Timeline as per their Classification. Table of Contents The process of getting FDA approval for a medical device can be lengthy and complex.The time it takes for a medical device to receive FDA approval can vary...

Class III Medical Devices : A Regulatory Overview

Oct 4, 2023

China

Class III Medical Devices : A Regulatory Overview

In this article, we will provide a comprehensive introduction to Class III medical devices, including what they are, how they are regulated, and what makes them different from other classifications. Whether you are a healthcare professional or simply interested in...

RegDesk Regulatory Roundup

Global Medical Device UDI Requirements: A Quick Reference Guide for United States, Europe, Canada, Japan & Australia

Streamlining Medical Device Development: Investigational Device Exemptions and 21 CFR 812

Understanding Electronic Records and Signatures: An Overview of 21 CFR Part 11

Voluntary FDA eSTAR Program

Decoding the USFDA Medical Device Approval Timeline

Class III Medical Devices : A Regulatory Overview

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