{"product_id":"fda-medical-device-establishment-registration-listing","title":"FDA Medical Device Establishment Registration \u0026 Listing","description":"\u003cp\u003eMedical device establishments selling in the US must register with FDA every year and list their devices. We prepare and submit registration and listing through FDA's FURLS system after you pay FDA's annual registration fee, which is $13,785 for FY2027 and is extra. Testing and labs are excluded. £445 for registration and one device; £90 per extra device.\u003c\/p\u003e\u003ch2\u003eWhat is device establishment registration and listing?\u003c\/h2\u003e\u003cp\u003eUnder \u003cstrong\u003eFD\u0026amp;C Act section 510\u003c\/strong\u003e and \u003cstrong\u003e21 CFR Part 807\u003c\/strong\u003e, establishments involved in making or distributing \u003cstrong\u003emedical devices\u003c\/strong\u003e for the US must \u003cstrong\u003eregister annually\u003c\/strong\u003e with \u003cstrong\u003eFDA\u003c\/strong\u003e and \u003cstrong\u003elist\u003c\/strong\u003e their devices, through the \u003cstrong\u003eFURLS\u003c\/strong\u003e system. Registration requires payment of the \u003cstrong\u003eannual establishment registration fee\u003c\/strong\u003e first. Foreign establishments must name a \u003cstrong\u003eUS agent\u003c\/strong\u003e. Registration and listing do not mean FDA has approved or cleared a device.\u003c\/p\u003e\u003ch3\u003eWhat's included in your registration and listing?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFee guidance\u003c\/strong\u003e: How to pay the FDA annual registration fee and get your PIN and PCN\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEstablishment registration\u003c\/strong\u003e: Submitted in FURLS\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice listing\u003c\/strong\u003e: Product code and device details listed\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS agent check\u003c\/strong\u003e: Confirms the US agent for a foreign establishment\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRenewal date\u003c\/strong\u003e: Annual renewal between 1 October and 31 December\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this service for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eMakers of menstrual cups, pads and other exempt devices\u003c\/li\u003e\n\u003cli\u003eForeign manufacturers exporting devices to the US\u003c\/li\u003e\n\u003cli\u003eBrands with a cleared 510(k) needing registration\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this service not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA fees.\u003c\/strong\u003e FDA's annual device establishment registration fee ($13,785 for FY2027, 1 Oct 2026 to 30 Sep 2027) is extra and paid by you.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTesting.\u003c\/strong\u003e Laboratory testing, lab fees and test reports are not included.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA 510(k).\u003c\/strong\u003e Needed separately for devices that are not exempt.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eA US agent.\u003c\/strong\u003e Available as a separate service.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA approval.\u003c\/strong\u003e Registration and listing are not FDA approval or clearance.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does FDA Medical Device Establishment Registration \u0026amp; Listing work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003ePay the FDA fee\u003c\/strong\u003e: We guide you through paying the annual fee.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your details\u003c\/strong\u003e: Establishment, devices, product codes and US agent.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubmit\u003c\/strong\u003e: We register and list in FURLS.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConfirmed\u003c\/strong\u003e: We send your registration and listing numbers. FDA processing time varies and is outside our control, so we do not guarantee a date.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch3\u003eWhat US law and FDA rules apply?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 510\u003c\/strong\u003e — registration and listing\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 807 Subpart B\u003c\/strong\u003e — registration and listing procedures\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR 807.40\u003c\/strong\u003e — foreign establishments and US agent\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 738\u003c\/strong\u003e — establishment registration fee\u003c\/li\u003e\n\u003cli\u003eOfficial sources:\u003c\/li\u003e\n\u003cli\u003e[Device Registration and Listing (FDA)](https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/device-registration-and-listing)\u003c\/li\u003e\n\u003cli\u003e[Medical Device User Fee Amendments (FDA)](https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/medical-device-user-fee-amendments-mdufa)\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eRelated services\u003c\/h3\u003e\u003cp\u003eBrowse \u003ca href=\"\/nl\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/nl\/products\/us-agent-for-foreign-medical-device-establishments-12-months\"\u003eUS Agent for Foreign Medical Device Establishments (12 Months)\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/fda-medical-device-classification-regulatory-pathway-report\"\u003eFDA Medical Device Classification \u0026amp; Regulatory Pathway Report\u003c\/a\u003e, \u003ca href=\"\/nl\/products\/medical-device-label-ifu-udi-review-fda\"\u003eMedical Device Label, IFU \u0026amp; UDI Review (FDA)\u003c\/a\u003e.\u003c\/p\u003e\u003cp\u003ePrepared by \u003cstrong\u003ePhoenix Compliance Services\u003c\/strong\u003e and reviewed by \u003cstrong\u003e\u003ca href=\"https:\/\/www.linkedin.com\/in\/shamuelshees\" rel=\"author\"\u003eSyed Muhammad Shamuel Shees\u003c\/a\u003e, US Regulatory Lead\u003c\/strong\u003e, with US agent and responsible person roles provided by Phoenix Safety Consultants LLC (USA), a sister company of Phoenix Compliance Services. FDA fees are not included and are passed through where they apply.\u003c\/p\u003e","brand":"Phoenix Compliance Services","offers":[{"title":"Registration and first device","offer_id":67824343875661,"sku":null,"price":445.0,"currency_code":"GBP","in_stock":true},{"title":"Each extra device","offer_id":67824343908429,"sku":null,"price":90.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/fda-medical-device-establishment-registration-listing.webp?v=1793176384","url":"https:\/\/phoenixcosmeticsafety.com\/nl\/products\/fda-medical-device-establishment-registration-listing","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}