Level:- Beginner to Intermediate
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
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?
- Technicians Quality Assurance
- Regulatory affairs
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 11 years.
Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.