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Medical Device 510K Submissions
- 510(k) Submission Process
- 510(k) Submission Methods
- Finding & Using Predicate Devices
- Preparing a Traditional 510(k)
- Preparing a Special 510(k)
- Preparing an Abbreviated 510(k)
Overview of the webinar
There are three types of 510(k) submissions that can be submitted – Traditional, Special, and Abbreviated.
The 510(k) process is considerably more rigorous than it once was, because of the following :
- Several international standards recognized by the FDA have become requirements for 510(k) submissions.
- The FDA mandated a more structured approach to 510(k) submissions, which includes submission of both paper and electronic copies.
- The FDA instituted the “Refuse-to-Accept” process
- The FDA reviewers typically subdivide the submission to various sub-reviewers who are evaluating the 510(k) submissions much more closely than in the past.
- Test labs must also meet specified standards (and be identified in the 510(k) submission).
- The FDA uses the “Additional Information Required” (AI) process to request more information.
Selecting the proper method and understanding the current changes to the process are critical to submissions success. This webinar will cover the process from start to finish – from finding and determining a predicate device, to selecting a submissions method and completing the submittal processes for each of those methods.
Who should attend?
This webinar has been designed for professionals new to the field and who require submissions knowledge to support their job function. These professionals include engineers, managers, supervisors, scientists, technicians involved in product development, manufacturing, quality assurance, or regulatory affairs for medical devices.
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.
Regulation 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.
Faculty - Mr.Charles H. Paul
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.