As the U.S. election approaches, industries closely regulated by federal agencies, like the medical device sector, are keenly watching for potential shifts in FDA regulations.

The FDA's release of the final guidance on marketing submission recommendations for Predetermined Change Control Plans (PCCPs) in AI-enabled device software represents a significant milestone in the regulation of advanced medical technologies.

Investigational devices are medical devices that are still undergoing evaluation and have not yet received regulatory approval or clearance from agencies like the FDA.

In medical device manufacturing, a robust Risk Management Plan (RMP) is essential to ensure the safety and efficacy of devices across their lifecycle.

On October 10, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) published its annual list of guidance document priorities for the upcoming 2025 fiscal year.

For medical device companies, selecting the first market for regulatory clearance is a pivotal decision.

On September 20, 2024, FDA released draft guidance titled “Chemical Analysis for Biocompatibility Assessment of Medical devices”.

For medical device companies, compliance with international quality standards is essential to ensure product safety, regulatory approval, and market access.

The In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) was released back in 2017 and represents one of the most impactful regulations ever within the medical device industry.

Artificial intelligence (AI) is revolutionizing industries worldwide, and the life sciences sector is no exception.

Cannabis and cannabis-derived products (CDPs) have become increasingly prevalent throughout the medical community.

Earlier this month, the FDA published a Discussion Paper titled “Health Equity for Medical Devices”.

On August 22, 2024, the FDA issued a new draft guidance document titled “Predetermined Change Control Plans for Medical Devices”.

The medical device landscape is rapidly evolving, with advances in technology and shifts in patient needs creating new opportunities for innovation.

On August 6, 2024, the Audit Approach document under the Medical Device Single Audit Program (“MDSAP”) was updated to Version 009.

In August 2024, the FDA announced the release of final guidance titled “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.”

The distinction between “servicing” and “remanufacturing” has often caused confusion throughout the medical device industry.

The impact of Artificial Intelligence (“AI”) is being seen throughout society, and the medical device community is no exception.

The FDA recently announced its planned enhancements to the Electronic Medical Device Reporting (eMDR) System.

Following years of discussion and debate, the FDA officially published its final rule covering laboratory developed tests (“LDTs”) on May 6, 2024.