FDA Device Inspections - Webinar Recording/Transcript

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FDA Device Inspections: Best Practices, New Guidance on 483 Feedback

Are you prepared for your next inspection? If you said yes, you might want to think again.

It’s time to discover what’s new in dealing with FDA inspectors, what they may and may not look into and what goes into the decision to issue a Form 483.

Special bonus: Deep dive into the recent FDA draft guidance on requesting nonbinding feedback on proposed remedial actions to observations issued in Forms 483. There are opportunities and risks to take into account. 

Takeaways:

  • What’s out of bounds: What the FDA may and may not inspect
  • Interacting with inspectors: What to do when snags arise
  • The CDRH ombudsman: When and how to use
  • Forms 483: How to respond, fallout from an inadequate response
  • Soliciting nonbinding 483 feedback: Impact of a new draft guidance
  • And much more!

Pass that next device inspection with flying colors! And if you have the bad luck to incur a Form 483, discover best ways to deal with it.

  • Regulatory affairs
  • Compliance affairs
  • Quality assurance/quality control
  • Manufacturing and contracting
  • Legal counsel

Rachael Hunt Esq., an associate at Hyman Phelps & McNamara PC, specializes in medical device regulatory strategy, compliance and enforcement. She helps medical device clients manage FDA approvals, clearances and appeals, and represents them in investigations conducted under the Food, Drug & Cosmetic Act and the False Claims Act.