Preparing a FDA 510(k) submission - What to Know

Level:- Beginner to Intermediate

Overview:

Preparing a submission to get FDA approval for a new product is time consuming and confusing. The submission requirements refer to many unfamiliar concepts and terms. More than half of all submissions are rejected by the FDA. We will teach you to prepare a submission meeting all the FDA requirements.

Areas Covered in the session:

• 510(k) unique terminology
• Refuse To Accept policy 
• what is a predicate device
• Selecting a predicate device (substantial equivalence)
• Where to find substantially equivalent predicate devices
• How to handle software

Learning Objectives:

This webinar will explain:

• What a 510(k) is and the procedure to prepare the submission.
• The several types of 510(k) will be explained.
• Each part of the submission will be explained.
• The very confusing concepts of predicate device and substantial equivalence will be discussed.
• How to find an acceptable predicate device will be taught.
• FDA places special emphasis on device software. we will also cover the requirements for software.

Why Should You Attend?

The medical device market is the largest market of all of the life sciences and it is generally valued at upwards of $90 billion with the expectation of continuous growth. This growth demands that the market be continually fed with new and innovative products.

Regulations have made the approval of products for market a complex process requiring manufacturers, to ensure their own survival, to be fully knowledgeable of the regulatory submissions process.

Understanding how to properly craft a submissions can save tremendous amounts of time and preparation cost and assure a favorable outcome.

Who will benefit?

• Engineers
• Managers
• Supervisor
• Scientists
• Technicians Quality Assurance
• Regulatory affairs