Attending Mass Medic Women in MedTech Forum on September 23, 2025, reinforced this point.
Having helped lift a consent decree and most recently achieved 510(k) clearance for an insulin pump, I can say from experience: 🚨the FDA is not your enemy. The FDA exists for a reason, to safeguard patients by ensuring that medical products are safe, effective, and reliable.
🚨Yes, reviewers are human. At times they may request additional testing that feels unnecessary in the moment (we faced this ourselves). The instinct is to push back. But the right approach is to engage, listen, and align. Debate rarely accelerates clearance. Collaboration does.
✔ Bring data and facts to the table.
✔ If disagreements arise, escalate through the primary reviewer or branch chief for a science-based resolution.
✔ In my experience, reviewers respond fairly when arguments are logical and evidence-based.
Marie Buharin, Senior Director Regulatory Affairs at Medtronic Diabetes, summarized this well with her Key Principles for Effective FDA Communication:
1. Regular Engagement: Build trust through recurring meetings.
2. Radical Transparency: Share openly, even if details are evolving.
3. Lead with Experts: Let SMEs, not just execs, drive discussions.
4. Build Relationships, Not Transactions: Treat every interaction as long-term.
5. Use Feedback as an Opportunity: Deficiencies are signals, not attacks.
6. Streamline Meetings: Keep groups tight and focused.
7. Proactive Cross-Functional Coordination: Connect FDA centers early.
These principles mirror what I’ve seen firsthand: strategy-to-execution alignment with regulators accelerates product clearance.