The Food and Drug Administration (FDA) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation.
The new regulation will incoporating reference to ISO 13485 medical device management system standard (edition 2016) and allows manufacturers to profit not only from cost savings, but also from improved time to market.
Transitional period of 2 years: The new regulation came into effect on 2 February 2026.
Also FDA has made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products whereas these edits do not impact the CGMP requirements for combination products.