Regulatory Updates.

The Modernization of Cosmetics Regulation Act (MoCRA) small business exemption period has ended as of January 2026. All cosmetics companies — regardless of revenue — must now comply with FDA facility registration and product listing requirements.

Impact: All cosmetics companies must register their facilities and list products with FDA immediately or risk enforcement action.

The FDA's Quality Management System Regulation (QMSR) is replacing 21 CFR Part 820, aligning the U.S. device quality system framework with ISO 13485:2016. Device manufacturers must begin transitioning their QMS documentation and processes now.

Impact: Device establishments must align quality management systems with ISO 13485 before the compliance deadline.

FDA has published updated implementation guidance for the FSMA Section 204 food traceability rule. Companies handling foods on the Food Traceability List (FTL) must establish Key Data Elements (KDEs) and Critical Tracking Events (CTEs) within their supply chains.

Impact: Food facilities handling FTL items must implement traceability recordkeeping systems to avoid non-compliance.

FDA has issued operational updates to the Structured Product Labeling (SPL) format required for drug establishment registration and product listing. The changes affect data field requirements and submission validation rules in the DRLS system.

Impact: Drug establishments must update their SPL submissions to match the revised field requirements during the next listing cycle.

FDA has published the updated user fee schedules for PDUFA, GDUFA, MDUFA, and other program areas for fiscal year 2026. Fee amounts have increased across most categories, reflecting adjusted cost recovery targets.

Impact: All establishments subject to user fees should verify updated payment amounts to ensure timely and accurate fee submission.

FDA is implementing enhanced prior notice filing requirements for imported food shipments, including additional data fields for country-of-origin verification and supply chain documentation. The changes aim to strengthen import screening capabilities.

Impact: Food importers must update prior notice filing processes to include expanded data fields before the March enforcement date.

FDA is expected to finalize Good Manufacturing Practice (GMP) regulations for cosmetics under MoCRA authority. The rule will establish baseline manufacturing, packaging, and holding requirements for all cosmetic facilities.

Impact: Cosmetic manufacturers must prepare to meet formal GMP requirements once the final rule is published.

The final compliance deadline for Unique Device Identification (UDI) labeling on Class I medical devices is approaching. All Class I devices must carry UDI labels and have their data submitted to the FDA's GUDID database.

Impact: Class I device manufacturers must ensure UDI labels are applied and GUDID records are current before the September deadline.