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The FDA renewal period for medical device establishments runs October 1 – December 31, 2026. This includes your U.S. Initial Importer. FDA fee for FY2027: $13,785 per establishment Initial importers must register and pay FDA’s annual establishment registration fee, just like manufacturers. By designating Provision as your Initial Importer, you avoid setting up and paying for your own initial importer registration. Why does this matter? Every foreign-made medical device sold i

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