Oct 12, 2023
FDA
The article addresses the aspects related to the existing legal framework associated with AST system devices and highlights the key points to be considered. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Read More
Oct 12, 2023
FDA
The article provides an overview of the regulatory requirements set forth under the existing framework and highlights the key points associated thereto. Table of Contents The FDA, the US healthcare product regulatory authority, has released a guidance document...
Read More
Oct 12, 2023
CDRH
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...
Read More
Oct 12, 2023
Asia
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...
Read More
Oct 12, 2023
CDRH
This article provides insights into 21 CFR Part 820, including an overview of the regulation, its requirements, and compliance strategies. Table of Contents The US Food and Drug Administration (FDA) is responsible for regulating medical devices marketed in the United...
Read More