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

This webinar will highlight changes to the Refuse to Accept (RTA) Policy for 510(k) and show how you can best leverage the tools available to you to ensure that you do not receive a Refuse to Accept decision.

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The FDA recently released a Draft Guidance detailing changes to their policy regarding acceptance and review of Premarket Notifications, more commonly known as the 510(k).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?

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.

Who Will Benefit:

• Regulatory Affairs Personnel
• Product Development Managers
• R&D Managers
• Clinical Affairs Personnel