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FDA requires every registered drug establishment to renew every year between October 1 and December 31. That window is open now. FDA fees for FY2027 Registration renewal and listing certification: FDA does not charge for the renewal itself. OMUFA facility fee (OTC monograph drug facilities only): Monograph Drug Facility (MDF): $47,891 Contract Manufacturing Organization (CMO): $31,927 This is about a 149% increase from FY2026 ($19,188 and $12,792). It is paid in two installme

FDA Food facility registration is renewed every two years, in even-numbered years. 2026 is a renewal year, and the window is October 1 – December 31, 2026. Renewal requires your facility’s DUNS information to match your registration exactly, and some facilities must submit additional attestations. Who needs to renew? Every domestic and foreign facility that manufactures, processes, packs, or holds food for U.S. consumption, including dietary supplements. What happens if you m

The FDA annual registration renewal period for medical device establishments is open now and closes December 31, 2026. Who needs to renew? Not only manufacturers. Every FDA-registered device establishment must renew each year, including: Manufacturers and contract manufacturers Specification developers Relabelers and repackagers Contract sterilizers and remanufacturers Initial importers What happens if you miss the deadline? Your establishment registration lapses. Shipments c

The U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), has released its proposed guidance agenda for Fiscal Year 2027. While the agenda does not establish new legal or regulatory requirements, it provides an important view into the topics CDRH intends to prioritize for guidance development and publication. For medical device manufacturers planning U.S. submissions, particularly 510(k), AI-enabled software, and novel device