510(k) Process for Medical Devices

• 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 to be resubmitted.
• Marketing and Postmarket Responsibilities: Know what your responsibilities are after your device is on the market.

• 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

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.

• 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.