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How to Prepare a 510(k) Submission

Duration : 60 Minutes

Edwin Waldbusser, Medical Device

Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, softwa Read more

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. We will teach you how to prepare a submission meeting all the FDA requirements.

Course Objectives:

We 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 cover the requirements for software. The requirements for preparing a 510(k) for a device modification will be discussed following the newly released guidance.

Course Outline:

• Unique terminologies in 510(k)
• What is 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
• 510(k) procedure for device modifications

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Engineering Personnel
• QA
• Software Developers
• Management
• Regulatory Personnel

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


Refund / Cancellation policy

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Subject : How to Prepare a 510(k) Submission

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