{"product_id":"fda-medical-device-classification-regulatory-pathway-report","title":"FDA Medical Device Classification \u0026 Regulatory Pathway Report","description":"\u003cp\u003eBefore selling a medical device in the US you need to know its FDA class and whether it needs a 510(k), is exempt, or needs another route. We research the classification regulation and product code, check exemptions and predicates, and give a written pathway report with next steps and fee notes. Testing and labs are excluded. £380 per device.\u003c\/p\u003e\u003ch2\u003eHow are medical devices classified in the US?\u003c\/h2\u003e\u003cp\u003eUnder \u003cstrong\u003eFD\u0026amp;C Act section 513\u003c\/strong\u003e, FDA places devices in \u003cstrong\u003eClass I, II or III\u003c\/strong\u003e by risk. Each type has a \u003cstrong\u003eclassification regulation\u003c\/strong\u003e in \u003cstrong\u003e21 CFR Parts 862–892\u003c\/strong\u003e and a \u003cstrong\u003eproduct code\u003c\/strong\u003e. Many Class II devices need a \u003cstrong\u003e510(k)\u003c\/strong\u003e premarket notification, while some are \u003cstrong\u003eexempt\u003c\/strong\u003e. For example, \u003cstrong\u003etampons\u003c\/strong\u003e are Class II and need a 510(k); \u003cstrong\u003emenstrual cups\u003c\/strong\u003e are Class II but exempt; \u003cstrong\u003eunscented pads\u003c\/strong\u003e are Class I and exempt. Every route still needs \u003cstrong\u003eestablishment registration and listing\u003c\/strong\u003e.\u003c\/p\u003e\u003ch3\u003eWhat's included in your pathway report?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice or not\u003c\/strong\u003e: Whether the product is a device, cosmetic or drug in the US\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eClassification\u003c\/strong\u003e: Likely class, regulation number and product code\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePathway\u003c\/strong\u003e: 510(k), 510(k)-exempt, De Novo or other route\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRequirements\u003c\/strong\u003e: Registration, listing, labelling, UDI and QMSR obligations\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFee notes\u003c\/strong\u003e: Current FDA user fees for the identified route\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWho is this report for?\u003c\/h3\u003e\u003cul\u003e\n\u003cli\u003eMakers of tampons, menstrual cups and pads\u003c\/li\u003e\n\u003cli\u003eBeauty device brands such as LED masks and microcurrent tools\u003c\/li\u003e\n\u003cli\u003eCosmetic brands unsure if a product is a device\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eWhat does this report 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.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eA 510(k) or other submission.\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAn FDA decision.\u003c\/strong\u003e The report is our assessment; only FDA can confirm a classification, for example through a 513(g) request.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eFDA fees.\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eHow does FDA Medical Device Classification \u0026amp; Regulatory Pathway Report work?\u003c\/h3\u003e\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eSend your product\u003c\/strong\u003e: Description, intended use, materials and claims.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eResearch\u003c\/strong\u003e: We search FDA's classification database and comparable devices.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReport\u003c\/strong\u003e: You receive the written pathway report.\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 513\u003c\/strong\u003e — device classification\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFD\u0026amp;C Act section 510(k)\u003c\/strong\u003e — premarket notification\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 807\u003c\/strong\u003e — registration, listing and 510(k)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003e21 CFR Part 884\u003c\/strong\u003e — obstetrical and gynaecological devices, including menstrual products\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\/fda-medical-device-establishment-registration-listing\"\u003eFDA Medical Device Establishment Registration \u0026amp; Listing\u003c\/a\u003e, \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\/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":"Default Title","offer_id":67824343777357,"sku":null,"price":380.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0622\/8262\/9197\/files\/fda-medical-device-classification-regulatory-pathway-report.webp?v=1793176384","url":"https:\/\/phoenixcosmeticsafety.com\/nl\/products\/fda-medical-device-classification-regulatory-pathway-report","provider":"Phoenix Cosmetic Safety","version":"1.0","type":"link"}