Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo

Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo is a webinar that covers topics such as:

  • Definitions
  • Applicable Statute(s) and Regulations
  • How to Request a Meeting
  • Recent FDA Policy and Process
  • What Questions to Ask to the FDA
  • How to Prepare for a Meeting Package
  • Regulatory Requirements for 510(k) and De Novo
  • How to Address Regulatory Questions to the FDA
  • Best Practices for Interacting with FDA Reviewers
  • Common Pitfalls and How to Prevent Them: Dos and Don’ts
  • Conclusion
  • PASS-IT Recommendations: Best Practices

Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo is intended for:

  • Research and Development Departments
  • Quality Assurance Departments
  • Clinical Affairs Professionals
  • Regulatory Affairs Departments
  • Compliance Officers
  • CEO’s and VP’s
  • Consultants
  • Documentation Departments
  • Everyone interested in the topic
  • Contractors / Subcontractors

Future Events

Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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