The FDA's New Device Pre-Submission Program

The FDA’s New Device Pre-Submission Program - Webinar CD/Transcript

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The FDA’s New Device Pre-Submission Program: What Does It Mean for You?

On February 18, the FDA issued an eagerly awaited, clarifying final guidance:

Requests for Feedback on Medical Device Submissions:
The Pre-Submission Program and Meetings with FDA Staff

This guidance helps you speed your approval process at the FDA by giving you an early take on how the agency is viewing your submission work.

That is, if your pre-submission is filed correctly. Done incorrectly, it can slow or even scuttle the development of your new medical device.

This webinar CD and transcript will give you a fuller understanding of the new guidance — and show you how to turn it into a beneficial and powerful approval tool.

The new final guidance contains substantial changes from the pre-submission draft guidance released by the FDA on July 13, 2012. It also replaces and supersedes the earlier 1999 version.

Additionally, it clarifies requirements on the type, timing, format and content of requests for feedback meetings and telephone conferences with the FDA.

There's a ton of information in this guidance for you to absorb, and in that regard, it isn't typical. Most guidance documents come in at 10-20 pages, but this one runs nearly 50. That's a hefty volume to take in and digest.

Yet, difficulties aside, there's real opportunity for devicemakers as well. Used carefully and correctly, the guidance can work as a new communications channel to speed your device's approval — and to help you avoid errors that might otherwise undermine it later in the process.

This FDAnews webinar CD and transcript is designed especially to help you get the most out of the new guidance.

But first, there's still more you should know about the complexities that are confronting you. The guidance also creates specific mechanisms for pre-submission communications and meetings for each of the following:

  • Premarket Approval (PMA) applications
  • Humanitarian Device Exemption (HDE) applications
  • Evaluation of Automatic Class III Designations (de novo petitions)
  • Premarket Notification (510(k)) Submissions
  • Clinical Laboratory Improvement Amendments (CLIA)
  • Certain Investigational New Drug (IND) applications and Biologics License Applications (BLAs)
  • Nonsignificant risk (NSR) devices, which are exempt from the FDA's usual premarket approval standards

Also, there's an organizational system you need to understand from the beginning.  The guidance dictates that all Pre-Subs and meeting requests will be referred to by the FDA as “Q-Subs” and will be assigned an official Q number.

Q numbers will, the FDA says, provide convenient and effective tracking for all the various types of requests for feedback — including meetings, teleconferences and requests for determination.

Phew. Is your head spinning yet?

Frankly, there's probably no time better than NOW to let FDAnews show you what you'll need to do to deal successfully with the new guidance.

So, we invited Albert Ghignone, the CEO of AAG and a respected speaker, to teach you specific tactics that will help you successfully request, prepare for and conduct FDA Pre-Submission Program meetings.

In 90 minutes, you'll get an insider's perspective on how the new pre-submission program will really work as well as how your company can leverage it. Specifically, you will learn:

  • How to properly use the Acceptance Checklist in Appendix 2 of the guidance to ensure all of the required criteria are explicitly addressed, prior to your Q-submission
  • How to prepare an effective pre-submission package to submit to the agency that will smooth the process down the road
  • How to understand and prepare for the different types of pre-submission meetings, including insight on which type to request and how to support that request
  • The most effective way to request, prepare for and conduct all varieties of pre-submission meetings
  • And much more.

If there was ever a time to ask for help, it's now. Why not order The FDA’s New Device Pre-Submission Program: What Does It Mean for You? webinar CD and transcript.

You'll have the benefit of an industry insider's 30 years of experience (when you need it most!), understanding of the complex nuances of the new guidance, detailed answers to your toughest questions, and tips to help turn the complexity of pre-submissions into a way to gain approval for your medical devices.

  • Regulatory Affairs Personnel
  • R&D Personnel
  • Submission and Approval Specialists
  • Compliance Professionals

Albert Ghignone is the CEO of AAG Incorporated. A widely respected speaker on the topic, he's has more than 30 years’ experience providing insights to industry on regulatory affairs, quality assurance and clinical affairs. He has expertise dealing with all aspect of the FDA approval process for medical devices, drugs, biologics and generics.

He has also worked inside companies in every major segment of the industry, including research, quality assurance, regulatory affairs, manufacturing and clinical.