16 - 20 June 2025
Mercure Hotel MOA Berlin, Berlin, GermanyHybrid Event I Attend In-Person or Digitallykeyboard_arrow_right
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Day Four – 19 June 2025 - CEST Time Zone
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Day Four – 19 June 2025 - CEST Time Zone
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Regulatory Affairs in Global Markets
09:00 - 09:10
Chairperson’s Opening Remarks: Regulatory Affairs in Global Markets
09:10 - 09:55
Overview of US FDA Regulation of Medical Devices
- About FDA
- Medical devices, IVDs, drugs, combination
- products and CDx: FDA divisions and offices
- FDA Centre for Devices and Radiological
- Health (CDRH)
- Code of Federal Regulations (CFR)
- Standards and other guidance documents
- Harmony & Discord
- A comparison of US and European Medical
- Device Regulatory Affairs
- Regulatory commonalities, overlaps and
- discrepancies
- Future trends
- An introduction to routes to the US Market
- Classification
- Premarket Notification – (510(k)
- Introduction to Traditional, Abbreviated,
- Special, de novo & Exemptions
- Predicates & substantial equivalence
- Premarket approval (PMA)
- Modules, modular and full submissions
- Role of QMS (CFR Part 820)
- Quality Assurance
- Quality Control
09:55 - 10:15
US Device Classification
- Classification: routes to market
- Comparison with EU/UK
- The 513(g) procedure
10:15 - 10:40
The Q-submission procedure
- What is Q-sub (still commonly known as a ‘pre-sub) and how does it benefit both the
- manufacturer and FDA
- How to prepare a ‘pre-sub’ document
- The ‘pre-sub’ meeting
- FDA feedback & follow up with the Agency
- Next steps
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Regulatory Affairs in Global Markets
11:10 - 11:50
Premarket Notifications - 510(k) Clearance
- The 510(k) process, different types of 510(k) and De Novo submissions
- Predicate Devices
- Contents of a 510(k) submission
- Decision Summaries
- Post-market considerations including modifications to cleared devices (post-market requirements): keeping product on the US market
11:50 - 12:40
Premarket Approvals (PMA): Devices, IVDs, CDx
- The PMA process and different types of PMAs
- Contents of a PMA submission
- Summary of Safety and Effectiveness Data (SSED)
- PMA Annual Reporting
- Modifications to approved devices
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Regulatory Affairs in Global Markets
14:10 - 14:20
Chairperson’s Afternoon Remarks: Regulatory Affairs in Global Markets
14:20 - 15:10
Product Development US Style
- Notification [510(k)] vs Approval (PMA) output data requirements
- Preclinical data: design verification
- Clinical data: design validation
- The importance of project management: saving time and cost to market
- Design change: pre-planned and/or response to market feedback
15:10 - 15:45
Quality System Regulation: 21 CFR 820
- Imposing Quality throughout the product lifecycle to save time and cost
- Role in Product Development, Design Control and Design Review
- Input to Risk Management
- Importance for manufacturing
- Quality Control
- Audits and Inspections
- Forthcoming regulatory changes
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Regulatory Affairs in Global Markets
16:15 - 17:00
Manufacture Regulations: 21 CFR 820 Subpart G
- Production and process controls
- Information Classification: General
- Inspection of measuring and test equipment
- Process validation
17:00 - 17:45
Open Discussion
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