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) regulation (21 CFR...

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...

Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not …

2024年12月24日 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing information in different file formats, see Instructions...

Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development; ICH Guidance Documents; Regulations: Good Clinical Practice and Clinical Trials

Chapter I —Food and Drug Administration, Department of Health and Human Services; Subchapter H —Medical Devices; Part 820 View Full Text

2024年6月27日 · FDA says it is now time to harmonize the two by replacing the QSR with the QMSR. The primary change here is that Subpart A of the new QMSR incorporates ISO 13485:2016 by reference as the basis for compliance with the QMSR but with some additions and differences as discussed below.