2024年11月21日 · On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more...

2024年1月31日 · The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS)...

ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable...

The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices.

2024年2月2日 · FDA has made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products. These edits do not impact the CGMP requirements for combination products.

2024年3月19日 · Introduction of QMSR: On February 02, 2024, the FDA announced the Quality Management System Regulation (QMSR), amending 21 CFR Part 820 by incorporating ISO 13485:2016 standards to streamline regulation and lessen the burden on device manufacturers.

2024年6月27日 · FDA has finally pushed the updated 21 CFR Part 820 across the finish line with the publication of the new Quality Management System Regulation (now called “QMSR”) on February 2, 2024. Here is what you need to know to transition from QSR to QMSR.

On January 31, 2024, FDA released its Final Rule for the new Quality Management System Regulation (QMSR). The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s Quality System Regulation (QSR) with the international consensus standard for medical device quality management systems, ISO ...

FDA uses the Quality System Inspection Technique (QSIT) to evaluate the alignment of internal quality system processes with regulatory requirements. The stakes of compliance are clear. Violations can result in 483 observations and warning letters.

2024年1月30日 · The FDA's Quality Management System Regulation (QMSR) final rule amends the Quality System Regulation (QSR) to harmonize and modernize the regulations. This significant regulatory update seeks to align more closely with the international consensus standard for medical devices by incorporating the quality management system (QMS) requirements ...