Description:-

This seminar will discuss what to consider and how to best prepare for premarket notification 510(k)s for submission to the FDA.  The speaker will walk you through how to format a new, succinct and comprehensive 510(k) package/dossier to increase submission quality and to facilitate the review process in a streamlined manner. 

You will leave the workshop empowered in preparing for your next 510(k) submissions. 

Why Should You Attend:-  

In 1976, the Medical Device Amendments (MDAs) to the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) created the concept of 510(k) program.  Under section 510(k) of the Act, device manufacturers are required to notify FDA of their intent at least 90 days prior to marketing a medical device in the US.

A premarket notification [510(k)] is the most common regulatory pathway to bring some medical devices into the US market. 

The 510(k) is made to the US Food and Drug Administration (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). 

This seminar will discuss what to consider and how to best prepare for the 510(k) submission package including dos and don’ts while ensuring 510(k) submission quality to prevent avoidable mistakes and delays and saving significant resources.

It is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the recent changes/requirements. 

Areas Covered In This 510(k) Workshop:- 

Session 1:- 12:00 PM - 01:20 PM

• Laws, Regulations and Definition
• 510(k) Regulatory Requirements
• Review of Related and Applicable Guidance, Documents and Standards
• Systematic Ways to Increase 510(k) Submission Quality
• Overview of 510(K) Program and Modifications

Session 2:- 1:40 PM - 3:00 PM

• What to Consider/Ensure While Preparing for a 510(k) Application
• Responding to FDA's Request for Additional Information.
• Resolving Different Opinions and Interpretations: Dos and Don'ts
• 510(k) Contents
• Common Drawbacks and Ways to Avoid to Prevent Them: Dos and Don'ts

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Who will benefit:- 

• Medical Device Quality and Compliance Professionals
• Pharmaceutical Compliance Professionals
• Quality
• Regulatory Affairs
• CEOs
• VPs
• Attorneys
• Clinical Affairs
• R&D
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the 510(k) Matters