Subscribe Newsletter510(k): Format and Contents
Overview: The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices.
Pursuant to the section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), the 510(k) premarket submission is made to FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device). In other words, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).
Thus, it is a must to adequately prepare your next 510(k) to get it successfully cleared in a timely manner, saving significant amount of your unnecessary time, energy, and other resources.
This webinar will discuss how to prepare a 510(k) quality submission including guidelines for the format and content of the 510(k). Please join and make sure you have all the bases and requirements for successful 510(k) submission package covered.
Why Should You Attend: It is crucial that device manufacturers understand 510(k) pitfalls and prepare against the pitfalls. Device firms should also consider the impact on your budget.
Thus, an adequate preparation of your next 510(k) to obtain successful clearance of your 510(k)s. This webinar will discuss how to prepare a 510(k) quality submission including guidelines for the format and content of the 510(k). Please join and make sure you have all the bases and requirements for the 510(k) submission package covered.
Areas Covered in the Session:
Who Will Benefit:
Pursuant to the section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), the 510(k) premarket submission is made to FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device). In other words, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).
Thus, it is a must to adequately prepare your next 510(k) to get it successfully cleared in a timely manner, saving significant amount of your unnecessary time, energy, and other resources.
This webinar will discuss how to prepare a 510(k) quality submission including guidelines for the format and content of the 510(k). Please join and make sure you have all the bases and requirements for successful 510(k) submission package covered.
Why Should You Attend: It is crucial that device manufacturers understand 510(k) pitfalls and prepare against the pitfalls. Device firms should also consider the impact on your budget.
Thus, an adequate preparation of your next 510(k) to obtain successful clearance of your 510(k)s. This webinar will discuss how to prepare a 510(k) quality submission including guidelines for the format and content of the 510(k). Please join and make sure you have all the bases and requirements for the 510(k) submission package covered.
Areas Covered in the Session:
- Applicable statute(s) and regulations
- Definitions and device classification
- When and who are required to submit a 510(k)
- How to identify a suitable predicate device(s), if any
- How to demonstrate substantial equivalence
- Recent changes in the 510(k) program
- Decision points during 510(k) review
- Differences in contents of 510(k)s based on products
- How to identify regulatory requirements relevant and applicable to the product(s)
- How to address the relevant and applicable regulatory requirements
- How to present your performance data and clinical data in a succinct, comprehensive manner
- How to increase 510(k) submission quality for a product
- How to respond to FDA’s request of additional information
- How to resolve different opinions between the submitter and FDA reviewer(s)
Who Will Benefit:
- Regulatory Affairs Managers, Directors and VPs
- Clinical Affairs Managers, Directors and VPs
- Quality Managers, Directors and VPs
- Quality Managers, Directors and VPs
- Compliance Managers and Directors
- Sales and Marketing Managers, Directors, and VPs
- Complaint Handling and Risk Management Managers and Directors
- Site Managers, Directors, and Consultants
- Senior and Executive Management
- Compliance Officers and Legal Counsel
- Business Development Managers, Directors, and VPs
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