One and Half-day In-person Seminar: Obtaining and Marketing Your 510(k) with Today (FDA GXP Compliance -)

Venue: Grand Hyatt San Francisco

Location: San Francisco, California, United States

Event Date/Time: Jun 28, 2012 End Date/Time: Jun 29, 2012
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Course Description:

Mark DuVal, a national authority on the 510(k) program is in Silver Spring, Maryland at FDA nearly twice a month negotiating 510(k)/IDE/PMA issues for his clients. He will teach you the basics and advanced knowledge of the 510(k) program. He will also provide insights in what FDA looks for in 510(k) submission and common mistakes companies make in drafting 510(k)s. This will include insights and commentary on CDRH’s new proposals for the 510(k) program. He will also discuss the plusses and minuses of pre-IDE meetings and how to approach them.

Mr. DuVal will address when and how to appeal adverse 510(k) decisions, whether it be an NSE decision or an Additional Information letter, learned in the trenches with FDA. This will include a workshop in which participants will be given hypotheticals to work on in small groups and share with the entire group the position they would take in an FDA appeal meeting.

On day two Mr. DuVal will spend a half day focusing on the promotional side of marketing a 510(k) starting with the analysis of how to take to market with a general intended use statement and specific uses (indications) to which the device may be put. He will cover FDA’s “General/Specific Intended Use” Guidance document and discuss how FDA approaches the interpretation of it using real examples. He will also share ideas for e-clearance/pre-approval communications, as well as the promotional issues companies face post-approval, including FDA’s enforcement activities with respect to the promotion of general versus specific uses. This will also include a workshop where the participants will again work in small groups to construct a promotional plan for a fictional medical device.

Who will Benefit:

- CEOs
- VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs
- Regulatory affairs
- Attorneys
- Quality Assurance
- Risk Managers
- Risk Management team members
- Quality Engineering
- Market Research
- Clinical
- MDR Reporters


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