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