Program Overview
This expert-led program provides a deep dive into FDA regulations governing medical devices, covering classification, submission pathways (510(k), PMA, De Novo), quality system requirements, and post-market obligations. Designed for corporates, the workshop blends conceptual clarity, situational awareness, case-based learning, and interactive simulations. Participants will explore regional compliance nuances, FDA enforcement trends, and real-world case studies of approvals, rejections, and recalls. The course equips professionals with practical skills and strategies to streamline submissions, avoid regulatory pitfalls, and ensure sustainable compliance for U.S. market entry.
Features
- Understand the FDA regulatory framework and submission pathways
- Recognize regional nuances and enforcement trends impacting compliance
- Apply insights from real-world cases of FDA approvals, rejections, and recalls
- Build a practical roadmap for successful and compliant U.S. market entry
Target audiences
- Regulatory Affairs and Quality Assurance Teams
- R&D Professionals
- Operations and Compliance Teams
- Supply Planners
- Market specialists
- Product managers
Curriculum
- 4 Sections
- 18 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- FDA Medical Device Regulatory Framework5
- 1.1FDA’s role in medical device oversight (CDRH – Center for Devices and Radiological Health)
- 1.2Device classification system: Class I, II, III
- 1.3Regulatory pathways: 510(k), PMA (Premarket Approval), De Novo classification, HDE (Humanitarian Device Exemption)
- 1.4Design Controls, QSR (Quality System Regulation), Labeling, UDI (Unique Device Identification)
- 1.5510(k), PMA, IDE (Investigational Device Exemption), QMS/QSR, Predicate Device, Substantial Equivalence, UDI Database (GUDID)
- Regional Nuances & Compliance Realities5
- 2.1Nuances across U.S. regions: field office inspections, enforcement priorities
- 2.2FDA expectations for clinical evidence & safety data
- 2.3How overseas manufacturers adapt to FDA requirements
- 2.4Challenges: Incomplete or incorrect 510(k) submissions, Insufficient evidence for PMA approval, Failures in post-market vigilance and MDR (Medical Device Reporting)
- 2.5Key Concepts: Warning Letters, 483 Observations, Recall Classifications, Post-Market Surveillance, eSTAR Submissions
- Approvals, Failures & Lessons Learned5
- 3.1Case Study 1: Successful 510(k) clearance using substantial equivalence strategy
- 3.2Case Study 2: PMA rejection due to inadequate clinical trial data
- 3.3Case Study 3: Market recall triggered by failure to meet post-market reporting obligations
- 3.4Discussion: What went wrong and what could have been done differently?
- 3.5Corporate best practices for FDA compliance
- Hands-On FDA Regulatory Problem Solving3
Instructor
