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 changes that have occurred over the years:
- 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.
Areas Covered in the session:
- 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)
- Define and describe the 510K Submissions process.
- Define a “predicate device".
- Explain how to find predicate devices.
- Describe how a 510K Submission is structured and assembled.
- Describe when a Traditional 510K submission must be executed.
- Explain the contents of a Traditional 510K submission.
- Explain when a Special 510K submission must be executed.
- Explain the contents of a Special 510K submission
- Explain when an abbreviated 510K submission must be executed.
- Explain the contents of an Abbreviated 510K Submission.
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?
This webinar has been designed for professionals new to the medical device field and who require submissions knowledge to support their job function.
These professionals include;
and professionals involved in product development, manufacturing, quality assurance, or regulatory affairs for medical devices.
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. The firm works with both domestic and international clients designing solutions for complex regulatory, training and documentation issues.