How to prepare a 510(k) FDA Submission
Instructor:
Edwin Waldbusser
Product ID: 705024
- Duration: 60 Min
Why Should You Attend:
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.
This webinar will explain what 510(k) is and the procedure to prepare the submission. It will explain the several types of 510(k) and each part of the submission will be discussed. 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 and it will also cover the requirements for software.
Areas Covered in the Webinar:
- 510(k) unique terminology
- What is a predicate device
- New "Refuse to accept policy"
- Electing a predicate device (substantial equivalence)
- Where to find substantially equivalent predicate devices
- How to handle software
Who Will Benefit:
- Engineering personnel
- R&D personnel
- Regulatory personnel
- QA
- IT
- Software developers
- Management
Edwin Waldbusser
Regulatory Consultant, Med Device Advisors
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 8 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.
More Training By Experts
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
