{"product_id":"fda-medical-device-approval-process-2026-10-06","title":"FDA Medical Device Approval Process","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis web seminar provides an overview of the regulations and obligations of a sponsor and investigator in the development of a new device using FDA and ICH guidance - Investigational Device Exemption (IDE) and abbreviated IDE processes. This is done by reviewing sponsor and investigator obligations, along with the principles of Good Clinical Practice (GCP). Definitions used by sponsors and regulatory authorities for device development will be reviewed. Participants will become familiar with the regulatory decision-making process used by the FDA and learn to navigate the approval pathways to market. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDiscuss the FDA regulations and practical application of sponsor and investigator obligations defined in 21CFR812\u003c\/li\u003e \u003cli\u003eDescribe the structure, purpose, and practical application of the ICH Guideline and its principles of GCP\u003c\/li\u003e \u003cli\u003eDescribe the technical standards defined in ISO\u003c\/li\u003e \u003cli\u003eDefine common terms used in device research\u003c\/li\u003e \u003cli\u003eDescribe the three decisions in device development (classification, equivalence, and risk)\u003c\/li\u003e \u003cli\u003eDefine the two pathways to market (PMA and 510(k))\u003c\/li\u003e \u003cli\u003eNavigate the FDA approval process\u003c\/li\u003e \u003cli\u003eDescribe what an IDE and PMA are, identify their contents, and discuss the FDA review process\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Research Managers\u003c\/li\u003e \u003cli\u003ePrincipal Investigators\u003c\/li\u003e \u003cli\u003eRegulatory Associates\u003c\/li\u003e \u003cli\u003eQuality Assurance Personnel\u003c\/li\u003e \u003cli\u003eAll other personnel responsible for the device approval process\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eShana Zink, B.S., C.C.R.A.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$735*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-24-051-L99-P. Released: 8\/24. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375371346285,"sku":"BI17465","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/fda-medical-device-approval-process-2026-10-06","provider":"Barnett International ","version":"1.0","type":"link"}