Exploring the FDA’s Refuse to Accept (RTA) Policy for 510(k)s

Why Should You Attend:

The FDA recently released a Draft Guidance detailing changes to their policy regarding acceptance and review of Premarket Notifications, more commonly known as the 510(k). This guidance will replace two earlier guidance documents and once implemented it will alter the ‘FDA review clock’ for purposes of the 2012 Medical Device User Fee Amendments (MDUFA) goals. Will these changes affect your product’s timely entry into the US Market?

This webinar is designed to highlight the changes you can expect with implementation of this updated Refuse to Accept (RTA) Policy for 510(k). We will review the anticipated advantages to industry and the Agency based upon the goals of this guidance.

If your role is related to preparing a 510(k) for submission to FDA or preparing for market launch following submission, this webinar will provide you a good overview of the changes that are taking place and how you can best leverage the tools available to you to ensure that you do not receive a Refuse to Accept decision.

Areas Covered in this Webinar:

• Guidance documents that are being replaced.
• Acceptance review.
• Substantive Review.
• Traditional, Special and Abbreviated 510(k).
• Pre-submission Resources.
• FDA Review Clock and MDUFA goals.
• What you can expect when you receive a RTA response.