For medical device companies, compliance with FDA regulations is not just a legal obligation—it is critical to ensuring patient safety, product quality, and business success. FDA inspections play a key role in verifying that companies meet regulatory requirements, and failure to comply can lead to serious consequences, including warning letters, product recalls, import bans, and even legal action.

The U.S. Food and Drug Administration (FDA) plays a critical role in ensuring the safety of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) by regulating donor eligibility and screening protocols.

Artificial Intelligence (AI) is revolutionizing healthcare, particularly in the medical device sector.

The FDA has released a draft guidance, Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics, outlining proposed updates to its policies and procedures for the accelerated approval pathway.

Informed consent is a cornerstone of ethical clinical research, but the FDA is now pushing for approaches that place patients at the heart of this process.

The Biosimilar User Fee Act (BsUFA) has been a key factor in expediting biosimilar approvals and enhancing regulatory efficiency in the U.S. Under the newly introduced BsUFA III, the FDA has launched the Regulatory Science Pilot Program, aimed at accelerating biosimilar development through cutting-edge research and regulatory practices.

The Global Unique Device Identification Database (GUDID) has become a cornerstone of regulatory compliance and supply chain transparency in the medical device industry.

The life sciences industry is evolving rapidly, driven by advances in technology, the globalization of markets, and increasingly complex regulatory landscapes.

The life sciences industry is entering a new era, shaped by rapid advancements in technology, evolving regulatory landscapes, and growing societal demands.

Artificial Intelligence (AI) has become a transformative tool in the life sciences industry, revolutionizing how Regulatory and Quality Compliance tasks are managed.

n the highly regulated landscape of life sciences, the role of regulatory affairs can often seem like a burden to innovation.

The appointment of Robert F. Kennedy Jr. (RFK Jr.) to a significant role in U.S. health policy could result in a major shift in regulatory and operational priorities for life sciences companies.

In 2024, medical device recalls have remained a crucial mechanism for maintaining patient safety and regulatory compliance.

Bringing a medical device to market requires more than innovation; it demands navigating complex regulatory frameworks, which vary significantly across regions.

As pharmaceutical and biotech companies strive to meet evolving FDA standards, they encounter rigorous inspections aimed at ensuring quality, safety, and compliance.

As healthcare technology continues to evolve, medical devices are increasingly connected to networks, patients, and other devices, making them susceptible to cybersecurity threats.

In 2024, the FDA remains focused on ensuring that medical device companies adhere to stringent regulatory requirements to guarantee patient safety and product quality.

Cybersecurity continues to evolve throughout all facets of the business world, and the medical device industry has taken notice.

Effective communication of information regarding drug interactions is vital to ensure appropriate use of pharmaceuticals and optimal decision-making by practitioners.

The FDA recently published four Final Guidance documents for medical devices involving dental-related products. These guidance documents cover the criteria for utilization of the Safety and Performance Based Pathway.