LIVE | March 26 (Tuesday), 2013 | 10:00 AM PST | 01:00 PM EST | Duration: 60 Minutes
About the Seminar
This presentation will walk you through the contents of three recent guidance documents issued by the US Food and Drug Administration (“US FDA” or “FDA”). The speaker will explain how to use the guidance documents most efficiently and effectively to streamline preparation of regulatory documents and submission to the FDA. Your familiarity with the new requirements will help you save significant time, efforts, energy and your business cost. Even if you feel you are prepared, please come and join our LIVE web seminar to ensure that the requirements are under check.
In this 60-min presentation, Regulatory Doctor will guide you through the details of the required elements to be adequately addressed in your regulatory submission.
About the Areas to Be Discussed
- Applicable statute(s), regulations, and definitions
- FDA’s new administrative checklist for 510(k)s, which is entitled “Refuse to Accept Policy for 510(k)s,” issued on December 31, 2012.
- FDA guidance on “eCopy Program for Medical Device Submissions,” issued on December 31, 2012
- FDA guidance on “Acceptance and Filing Reviews for Premarket Approval (PMA) Applications“
- Practical, actionable, and sustainable strategies
About the Intended Attendee(s)
- Regulatory Affairs
- Clinical Affairs
- Legal Counsel
- Compliance Officers
- Regulatory Agency Personnel
- Anyone interested in FDA 510(k) and PMA submissions