{"product_id":"medical-device-label-ifu-udi-review-fda","title":"Medical Device Label, IFU \u0026 UDI Review (FDA)","description":"\u003cp\u003eMedical device labels sold in the US must meet 21 CFR Part 801, and most need a unique device identifier under 21 CFR Part 830. We review your label, instructions for use and UDI, including special rules such as tampon absorbency and TSS warnings, and mark up required changes. Testing and labs are excluded. £740 per device.\u003c\/p\u003e\u003ch2\u003eWhat do US medical device labels need?\u003c\/h2\u003e\u003cp\u003e\u003cstrong\u003e21 CFR Part 801\u003c\/strong\u003e sets \u003cstrong\u003eFDA\u003c\/strong\u003e device labelling rules: the \u003cstrong\u003ename and place of business\u003c\/strong\u003e of the manufacturer, packer or distributor, \u003cstrong\u003eadequate directions for use\u003c\/strong\u003e, and warnings. \u003cstrong\u003e21 CFR Part 830\u003c\/strong\u003e requires most devices to carry a \u003cstrong\u003eunique device identifier (UDI)\u003c\/strong\u003e, with data submitted to \u003cstrong\u003eGUDID\u003c\/strong\u003e. Some devices have specific rules, such as \u003cstrong\u003etampons\u003c\/strong\u003e, which need absorbency ranges and \u003cstrong\u003etoxic shock syndrome\u003c\/strong\u003e information under \u003cstrong\u003e21 CFR 801.430\u003c\/strong\u003e.\u003c\/p\u003e\u003ch3\u003eWhat's included in your label review?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eLabel\u003c\/strong\u003e: Name and place of business, intended use and required statements under 21 CFR 801\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInstructions for use\u003c\/strong\u003e: Adequate directions, warnings and precautions\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eUDI\u003c\/strong\u003e: Device identifier format and GUDID data points\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSpecial rules\u003c\/strong\u003e: Such as tampon absorbency ranges and TSS warnings (21 CFR 801.430)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecheck\u003c\/strong\u003e: One recheck of revised labels\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this review for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eMakers of tampons, menstrual cups and pads\u003c\/li\u003e\n\u003cli\u003eBeauty device brands\u003c\/li\u003e\n\u003cli\u003eForeign manufacturers adapting labels for the US\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this review not include?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eTesting.\u003c\/strong\u003e Laboratory testing, lab fees and test reports are not included. Absorbency and other claims need test evidence.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eGUDID account setup or issuing-agency fees.\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eLabel design.\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eFDA fees.\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does Medical Device Label, IFU \u0026amp; UDI Review work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your materials\u003c\/strong\u003e: Labels, IFU, packaging and intended use.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview\u003c\/strong\u003e: We check each element against FDA rules.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReport\u003c\/strong\u003e: You receive marked-up labels and IFU.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecheck\u003c\/strong\u003e: One recheck is included.\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 Part 801\u003c\/strong\u003e — device labelling\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR 801.430\u003c\/strong\u003e — tampon labelling\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 830\u003c\/strong\u003e — unique device identification\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-classification-regulatory-pathway-report\"\u003eFDA Medical Device Classification \u0026amp; Regulatory Pathway Report\u003c\/a\u003e, \u003ca href=\"\/fr\/products\/fda-medical-device-establishment-registration-listing\"\u003eFDA Medical Device Establishment Registration \u0026amp; Listing\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":67824346890317,"sku":null,"price":740.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/medical-device-label-ifu-udi-review-fda.webp?v=1793176384","url":"https:\/\/phoenixcosmeticsafety.com\/fr\/products\/medical-device-label-ifu-udi-review-fda","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}