Do you know how to get your devices approved while avoiding common pitfalls and costly delays? Medical device companies must have FDA 510(k) approval to market products in the United States. Learn the best way to get your approval to market in the U.S., what is needed to complete the 510(k) process, and when a 510(k) must be submitted. Our 510(k) process training, presented by industry experts using hands-on workshops, covers the requirements needed so you can get your product on the market.

Understand how to submit a successful 510(k) for a device or a device change as quickly and efficiently as possible to avoid regulatory issues and unnecessary expenses. Make sure your 510(k) submission can be quickly reviewed by the FDA so you can stay ahead of the competition.

Course Objectives

• Introduction of the 510(k) Submission Process—Understand the elements of premarket notification 510(k) submissions for medical devices.
• Requirements—Use hands-on workshops to compare your medical device to a substantial equivalent product and/or predicate device.
• The Process—Learn what is expected and when a 510(k) is needed.
• Modifications—Understand when a device needs tobe resubmitted.
• Marketing and Postmarket Responsibilities—Know what your responsibilities are after your device is on the market.

Topics

• FDA’s regulatory classifications and requirements
• Primary routes to market: PMA/510(k)s and exemptions
• Elements of the 510(k) and definitions
• Selecting a predicate
• General 510(k) principles on what to expect
• 510(k) structure—traditional, abbreviated, special
• Modifications to devices and resubmission
• Marketing and postmarket responsibilities

Who Should Attend
This course is designed for professionals involved with premarket notification to the FDA. Recommended for anyone heavily involved in approving the design and marketing of medical devices. Some knowledge of FDA regulations is helpful.

Who must submit an FDA 510(k)?

• Manufacturers or importers/exporters who want to introduce a new device (having a predicate device) to the U.S. market.
• Manufacturers who are introducing a new finished device to the
  U.S. market.
• Specification developers designing a device that is manufactured by another company for sale in the U.S.
• Companies proposing a significantly different design or intended use for a product sold in the U.S.
• Device repackagers or relabelers.

CEUs: 1.5
Days: 2