The United States Food and Drug Administration (US FDA) released the highly anticipated revised Quality Management System Regulation (QMSR) in February 2024. The updated regulation serves as the new set of Good Manufacturing Practices (GMP) guidelines of the US FDA for medical devices, effectively replacing the previous set of Quality System Regulations (QSR). The US FDA QMSR now aligns more closely with the ISO 13485:2016, the international standard for medical device Quality Management System (QMS).

21 Code of Federal Regulations (CFR) Part 820, also known as the Quality System Regulation (QSR), is part of the United States (US) CFR that establishes the criteria under which medical devices are manufactured. It covers various aspects of the manufacturing process, including design, production, labeling, storage, installation, and servicing of medical devices. The regulation is enforced by the US Food and Drug Administration (FDA), and it aims to ensure that medical devices are safe and effective for their intended use.

As a medical device manufacturer, you must understand and prepare for the United States Food and Drug Administration’s (US FDA’s) inspections to maintain compliance and ensure that your medical device can be marketed and distributed without legal impediments. The US FDA’s Regulatory oversight includes ensuring that devices are safe, effective, and meet the necessary quality standards. Here is what you need to know about the US FDA’s inspections and enforcement actions and how to prepare for them.

21 Code of Federal Regulations (CFR) Part 820, also known as the Quality System Regulation (QSR), is part of the United States (US) CFR that establishes the criteria under which medical devices are manufactured. It covers various aspects of the manufacturing process, including design, production, labeling, storage, installation, and servicing of medical devices. The regulation is enforced by the US Food and Drug Administration (FDA), and it aims to ensure that medical devices are safe and effective for their intended use.

The United States (US) represents one of the largest medical device markets in the world, offering significant opportunities to foreign manufacturers. However, medical device manufacturers seeking to access the US market need to navigate the complex Regulatory landscape of the US Food and Drug Administration (FDA). They must understand and comply with the US FDA’s regulations to successfully launch their products in the US.

Navigating the complex landscape of medical device regulations can be a daunting task for manufacturers and healthcare professionals. The United States Food and Drug Administration (US FDA) classifies medical devices into different categories, based on risk, intended use, and other factors. Understanding these classifications is crucial for ensuring compliance as well as the safety and efficacy of medical devices.

The journey of bringing a medical device to the United States (US) market is a complex process governed by the US Food and Drug Administration (FDA). Manufacturers must understand the US FDA’s Regulatory pathway to ensure that their devices meet the necessary standards of safety and efficacy. This blog provides an overview of the US FDA’s Regulatory framework for medical devices, the types of submissions it covers, the timelines, and key considerations for navigating the agency’s approval process.

The US Food and Drug Administration (USFDA) has proposed the harmonization of the 21 Code of Federal Regulations (CFR) Part 820 Quality System Regulation (QSR) for medical devices in accordance with the International Organization for Standardization (ISO) 13485:2016.

What is the Role of Cybersecurity in Medical Devices?

Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.