How to Prepare a 510(k) Submission

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.

Areas Covered in the Session :

• 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

Who Should Attend:

• Quality Assurance Departments
• Regulatory Affairs Departments
• Engineering Departments
• Research and Development Departments
• IT Departments
• Software Developers

Course Director: Edwin Waldbusser

Edwin Waldbusser 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, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.