Upcoming Changes

Overview

This page tracks Upcoming Changes for US FDA medical device regulation.

Official sources

• Federal Register — FDA
• Regulations.gov — FDA
• FDA What's New

Add a timeline table showing: Effective Date, Regulatory Change, Regulatory Authority (FD&C Act section or 21 CFR part), and Description of Impact. Include upcoming deadlines, guidance releases, and regulatory milestones (e.g., QMSR updates, LDT oversight phases).