Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo 2019

6 June 2019
Webinar

Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo 2019 will be held on 6 June 2019.

Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo 2019 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 2019 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
200-700 US Dollar
No exhibition
Rentalcars Savings

Future Events

  Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo 2019  6 Jun 2019 (84867)

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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