How to Market Medical Devices in the U.S.

Course details

Description

Understanding the FDA's regulatory system is the first objective for device manufacturers looking to sell in the U.S. The 510(k) Premarket Notification submission should be prioritized when developing a medical device. This pathway provides marketing clearance and the ability to sell your medical devices in the U.S. Before sales can occur companies have two options: 510(k) Premarket Notification (unless exempt); or Premarket Approval (PMA) approval. PMA's are resource intensive, and so 510(k)'s are the ideal submission type.

Areas Covered in the seminar:

• U.S. FDA medical device methodology
• Class I, II, and III devices
• How to identify Class I, 510(k)-exempt devices
• The three types of 510(k)'s
• 510(k) determination - new; and substantially modified
• Intended Use statement - key insights
• How to locate predicate devices
• How to interact with the FDA
• FDA Review timelines
• Post-submission review
• Common questions by the FDA

Who will benefit:

• Executive Management
• Product Management
• Engineering
• Regulatory Affairs personnel
• Quality Assurance personnel