Update on FDA 510(k) Review Process, Hurdles and Good Practices on 510(k) Preparation and Clearance

Overview:

This webinar is intended to share 510(k) hurdles and good practices, in particular, how to prepare a 510(k) in a sufficiently adequate manner with increased quality to expedite review process. 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). To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device manufacturers understand the 510(k) processes and be able to prepare high quality 510(k) applications: in particular, 510(k) format and contents. 

This webinar will provide opportunities to get better aware of and become familiar with the common pitfalls and good practices including adequate contents and format so that your next 510(k) should facilitate FDA's 510(k) review process using CAC-SI method. 

Why Should You Attend: A premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices. 
It is crucial that your 510(k) preparation should be adequate to achieve quality submission, thereby significantly contributing to expediting the review process and saving millions of dollars for your business. This webinar will discuss hurdles and good practices for effectively preparing for your 510(k) and having it cleared in a less burdensome manner. 

Areas Covered in the Session:

• Statute(S), Regulations And Definitions
• When To Submit a 510(K)
• Predicates And Substantial Equivalence
• E-Copy Program
• Refuse To Accept Policy
• Regulatory Requirements
• Required Information in a 510(k)
• 510(k) Contents and Format
• Common Pitfalls
• Avoiding or Reducing Disagreements
• Responding to Additional Information Request
• Increasing 510(k) Submission Quality
• Standards
• Good Practices for Maximum Benefits
• Speaker's PASS-IT Suggestions/Recommendations

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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