Recent Regulatory Changes

Last updated: May 2026.

2024–2026

Date	Change	Impact
Feb 2, 2026	QMSR effective	21 CFR Part 820 updated, ISO 13485:2016 incorporated
May 2024	LDT Final Rule	Phased FDA oversight of lab-developed tests
2024	PCCP Guidance finalised	AI/ML SaMD change management framework
Oct 2023	eSTAR mandatory	Required format for all 510(k) and De Novo submissions

Official sources

• FDA What's New in Medical Devices
• Federal Register — FDA