Understanding the FDA’s new guidance

The FDA's new device pre-submission program: What does it mean for you?

April 10, 2014
Manufacturing Group

Falls Church, Virginia – On February 18, the FDA issued an eagerly awaited, clarifying final guidance. This guidance helps speed the approval process at the FDA by giving you an early take on how the agency is viewing the submission work. That is, if the pre-submission is filed correctly. Done incorrectly, it can slow or even scuttle the development of a new medical device.

To help navigate this guidance is an FDA webinar planned for April 21, 2014, from 1:30 p.m. – 3:00 p.m. EDT. This must-attend event will give a fuller understanding of the new guidance and show 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The new final guidance contains substantial changes from the pre-submission draft guidance released by the FDA on July 13, 2012.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 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 the device's approval and to help avoid errors that might otherwise undermine it later in the process.

This FDAnews webinar is designed especially to help devicemakers get the most out of the new guidance.

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

In 90 minutes, attendees will get an insider's perspective on how the new pre-submission program will really work as well as how companies can leverage it. Specifically, attendees 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 the 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

If there was ever a time to ask for help, it's now. Register for The FDA's New Device Pre-Submission Program: What Does It Mean for You? Attendees have the benefit of an industry insider's 30 years of experience, understanding of the complex nuances of the new guidance, detailed answers to the toughest questions, and tips to help turn the complexity of pre-submissions into a way to gain approval for medical devices. Meet the Presenter: 

Albert Ghignone is the CEO of AAG Inc. 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.

Who will benefit: 

  • Regulatory affairs personnel
  • R&D personnel
  • Submission and approval specialists
  • Compliance professionals

Conference details: 

The FDA's New Device Pre-Submission Program: What Does it Mean for You? 
April 21, 2014 – 1:30 p.m. – 3:00 p.m. EDT 

Tuition: $547 per site – includes webinar registration and audio cds and transcripts


Online or by phone: 888.838.5578 or 703.538.7600.

Source: FDA