Why should you attend:
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3). In other words, firms must demonstrate that a proposed product is substantially equivalent to another, a legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.
To expedite the process of bringing a product to market through the 510(k) program, it is imperative that the medical device manufacturers understand how to expedite the FDA review process leading to a prompt clearance in view of recent trends and customized strategy for a successful clearance.
This presentation is intended to demonstrate how to improve submission quality, which will subsequently prevent avoidable delays and reduce review times.
In this webinar, we will discuss:
Statute(s) and Regulations
Definitions
Medical Device Classification
510(k) Process
Selecting Predicate Device(s)
De Novo Process – Practical Advice
How To Demonstrate Substantial Equivalence
510(K) Contents And Format
Addressing Technical And Regulatory Requirements.
510(k) Submission Quality For A Product-Be Aware.
Responding to FDA’s Request Of Additional Information.
Resolving Different Opinions Between The Submitter And FDA Reviewer(S).
Avoiding Common Mistakes with Awareness
510(k) Trends
510(k) Preparation: Dos and Don’ts for Best Practices
Speaker’s PASS-IT Recommendations
This webinar will provide valuable assistance and great opportunities to all personnel involved as further described below.
This webinar will be valuable for anyone in the FDA-regulated industry including, but not limited to, medical device, drugs, biologics and in vitro diagnostic devices. It is particularly useful for those who are engaged in the design and development of medical devices, combinations products (e.g., drug and devices, biologics and devices), and in vitro diagnostic devices including companion medical products. This webinar is a must for those who are directly or indirectly involved in handling 510(k) regulatory submissions to the FDA.
Who will benefit:
Personnel involved in regulatory affairs (associates, specialists, managers, and directors).
Personnel involved in clinical affairs (associates, specialists, coordinators, managers and directors)
Personnel involved in quality assurance, quality control and quality systems (associates, specialists, engineers, managers, and directors)
Personnel involved in research and development (associates, scientists, managers, and directors)
Site managers, and consultants
Other interested stakeholders (upper management personnel).
For More Details:​https://www.grcts.com/GRC-90075.
Email:david@grcts.com | Tel:+1-248-233-2049 | Web:www.grcts.com
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs). The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3). In other words, firms must demonstrate that a proposed product is substantially equivalent to another, a legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.
To expedite the process of bringing a product to market through the 510(k) program, it is imperative that the medical device manufacturers understand how to expedite the FDA review process leading to a prompt clearance in view of recent trends and customized strategy for a successful clearance.
This presentation is intended to demonstrate how to improve submission quality, which will subsequently prevent avoidable delays and reduce review times.
In this webinar, we will discuss:
Statute(s) and Regulations
Definitions
Medical Device Classification
510(k) Process
Selecting Predicate Device(s)
De Novo Process – Practical Advice
How To Demonstrate Substantial Equivalence
510(K) Contents And Format
Addressing Technical And Regulatory Requirements.
510(k) Submission Quality For A Product-Be Aware.
Responding to FDA’s Request Of Additional Information.
Resolving Different Opinions Between The Submitter And FDA Reviewer(S).
Avoiding Common Mistakes with Awareness
510(k) Trends
510(k) Preparation: Dos and Don’ts for Best Practices
Speaker’s PASS-IT Recommendations
This webinar will provide valuable assistance and great opportunities to all personnel involved as further described below.
This webinar will be valuable for anyone in the FDA-regulated industry including, but not limited to, medical device, drugs, biologics and in vitro diagnostic devices. It is particularly useful for those who are engaged in the design and development of medical devices, combinations products (e.g., drug and devices, biologics and devices), and in vitro diagnostic devices including companion medical products. This webinar is a must for those who are directly or indirectly involved in handling 510(k) regulatory submissions to the FDA.
Who will benefit:
Personnel involved in regulatory affairs (associates, specialists, managers, and directors).
Personnel involved in clinical affairs (associates, specialists, coordinators, managers and directors)
Personnel involved in quality assurance, quality control and quality systems (associates, specialists, engineers, managers, and directors)
Personnel involved in research and development (associates, scientists, managers, and directors)
Site managers, and consultants
Other interested stakeholders (upper management personnel).
For More Details:​https://www.grcts.com/GRC-90075.
Email:david@grcts.com | Tel:+1-248-233-2049 | Web:www.grcts.com
