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.

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.

When a foreign establishment engages in the production of a medical device imported into the United States (US), it is mandatory to designate a US agent for that establishment. The US agent serves as the point of contact for any US Food and Drug Administration (US FDA) communication related to the foreign registered facility.

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.

Software as a Medical Device (SaMD) is a burgeoning field that offers innovative solutions to enhance patient care and reduce healthcare costs. The International Medical Device Regulators Forum (IMDRF) describes SaMD as a software tool intended for use in one or more medical purposes, and which meet these purposes without being part of a hardware medical device. SaMD includes both medical devices as well as in-vitro medical devices. The USFDA has implemented SaMD regulations to ensure that the devices meet the same safety and efficacy standards as traditional medical devices.