Guide to The FDA 510(k)- Common Mistakes That Can Tank Your 510(k) Submission
Step-by-step Instructions for A Successful 510(k) Submission!
Instructor :
Charles H. Paul
Webinar ID:
4143
Date: 11 November 22, FRI
Start Time: 10 am PT
Duration: 1 Hr.
What you will learn
- Define and Describe The 510K Submissions Process
- Define and Describe 510(k) Submission Methods
- Define a “Predicate Device.”, How to Find Predicate Devices
- How a 510K Submission is Structured and Assembled
- Define and Describe The 510K Submissions Process
- Define and Describe 510(k) Submission Methods
- Define a “Predicate Device.”, How to Find Predicate Devices
- How a 510K Submission is Structured and Assembled
- Preparing a Traditional 510(k), When a Traditional 510K Submission Must be Executed
- Preparing a Special 510(k), When a Special 510K Submission Must be Executed
- Preparing an Abbreviated 510(k), When An Abbreviated 510K Submission Must be Executed
Course Description
75% of the first time 510(k) submissions are rejected the FDA! 85% of 510(k)s that are rejected are done so because of poor substantial equivalence. That’s just staggering!
Are you ready to sell your medical devices in the United States? Before you enter the US market, you need clearance from the US Food and Drug Administration, which means you probably need to submit a 510(k).
There are 3 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” (RTA) 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!
Charles H. Paul, a regulatory consultant for over 20 years, 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.
Join us now!
75% of the first time 510(k) submissions are rejected the FDA! 85% of 510(k)s that are rejected are done so because of poor substantial equivalence. That’s just staggering!
Are you ready to sell your medical devices in the United States? Before you enter the US market, you need clearance from the US Food and Drug Administration, which means you probably need to submit a 510(k).
There are 3 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” (RTA) 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!
Charles H. Paul, a regulatory consultant for over 20 years, 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.
Join us now!
Why you should attend
If a submission is kicked back because of scientific review, then that is the FDA is doing its job exactly as it’s supposed to. But, if a submission is kicked back on administrative review — in other words, because of the RTA guidance — then, quite frankly, that’s the company’s fault.
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!
The key takeaways or learnings from this webinar are:
- How to select the submission type for your medical device
- Understanding how the submissions are prepared
- The contents of each submission type
- Understanding the FDA review process
- Why understanding the review process is critical to your submission’s success
Join Now!
If a submission is kicked back because of scientific review, then that is the FDA is doing its job exactly as it’s supposed to. But, if a submission is kicked back on administrative review — in other words, because of the RTA guidance — then, quite frankly, that’s the company’s fault.
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!
The key takeaways or learnings from this webinar are:
- How to select the submission type for your medical device
- Understanding how the submissions are prepared
- The contents of each submission type
- Understanding the FDA review process
- Why understanding the review process is critical to your submission’s success
Join Now!
Areas Covered
- 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
- 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
Who is this course for
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 engineers, managers, supervisors, scientists, technicians involved in product development, manufacturing, quality assurance, or regulatory affairs for medical devices.
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 engineers, managers, supervisors, scientists, technicians involved in product development, manufacturing, quality assurance, or regulatory affairs for medical devices.
Instructor Profile
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 to the life sciences industry 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 human performance and compliance-related problems.