{"product_id":"us-agent-for-foreign-medical-device-establishments-12-months","title":"US Agent for Foreign Medical Device Establishments (12 Months)","description":"\u003cp\u003eForeign medical device establishments must name a US agent who lives or has a place of business in the US, under 21 CFR 807.40. Phoenix Safety Consultants LLC acts as your US agent for 12 months, receives FDA communications and helps FDA arrange inspections. FDA fees, testing and labs are excluded. £565 per year.\u003c\/p\u003e\u003ch2\u003eWhat is a US agent for medical devices?\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003e21 CFR 807.40\u003c\/strong\u003e requires every \u003cstrong\u003eforeign establishment\u003c\/strong\u003e that registers with \u003cstrong\u003eFDA\u003c\/strong\u003e to name a \u003cstrong\u003eUS agent\u003c\/strong\u003e who resides or keeps a place of business in the US. FDA contacts the US agent to \u003cstrong\u003econfirm the designation\u003c\/strong\u003e, sends \u003cstrong\u003ecommunications\u003c\/strong\u003e through them, and may ask them to help \u003cstrong\u003earrange inspections\u003c\/strong\u003e. \u003cstrong\u003ePhoenix Safety Consultants LLC\u003c\/strong\u003e acts as your US agent.\u003c\/p\u003e\u003ch3\u003eWhat's included in your US agent service?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eUS agent designation\u003c\/strong\u003e: Phoenix Safety Consultants LLC named in your registration\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFDA communications\u003c\/strong\u003e: Received and forwarded promptly\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInspection scheduling\u003c\/strong\u003e: Assist FDA in arranging inspections\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgreement\u003c\/strong\u003e: Written duties and term\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this service for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eUK, EU and other non-US device manufacturers\u003c\/li\u003e\n\u003cli\u003eMakers of menstrual and beauty devices exporting to the US\u003c\/li\u003e\n\u003cli\u003eEstablishments whose US agent is changing\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\u003eRegistration and listing.\u003c\/strong\u003e Available separately.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eImporter or distributor duties.\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does US Agent for Foreign Medical Device Establishments work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eAgreement\u003c\/strong\u003e: You sign the US agent agreement.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDesignate\u003c\/strong\u003e: You or we name Phoenix Safety Consultants LLC in FURLS.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eConfirm\u003c\/strong\u003e: FDA contacts the US agent to confirm.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCover\u003c\/strong\u003e: 12 months of US agent service.\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\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 510(i)\u003c\/strong\u003e — foreign establishment registration\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=\"\/fr\/collections\/all-services\"\u003eall Phoenix compliance services\u003c\/a\u003e, or see \u003ca href=\"\/fr\/products\/fda-medical-device-establishment-registration-listing\"\u003eFDA Medical Device Establishment Registration \u0026amp; Listing\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/fda-medical-device-classification-regulatory-pathway-report\"\u003eFDA Medical Device Classification \u0026amp; Regulatory Pathway Report\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":"Default Title","offer_id":67824346792013,"sku":null,"price":565.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/us-agent-for-foreign-medical-device-establishments-12-months.webp?v=1793176386","url":"https:\/\/phoenixcosmeticsafety.com\/fr\/products\/us-agent-for-foreign-medical-device-establishments-12-months","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}