ComplianceOnline Announces Seminar on Obtaining and Marketing FDA 510K Application

– ComplianceOnline, the leading GRC advisory network, and renowned FDA regulatory expert and lawyer Mark DuVal will conduct a one-and-a-half day, in person seminar on obtaining and marketing a 510(k) application with today’s FDA.

Online PR News – 12-June-2012 – USA – Palo Alto, CA, USA – May 24, 2012 – ComplianceOnline, the leading governance, risk and compliance advisory network, today announced a seminar on Obtaining and Marketing Your 510(k) with Today's FDA, a 510(k) Workshop. The one-and-a-half day, in-person seminar, led by nationally renowned FDA regulatory expert and lawyer Mark DuVal, will be held on June 28 and 29, 2012, in San Francisco, CA.

The seminar will help attendees learn how to get their 510(k) applications through the FDA quickly, saving millions of dollars in costs. The course has been pre-approved by RAPS and attendees are eligible for up to 10.5 credits towards their RAC certification upon completion.

For more information or to register for the seminar, please click here.

Seminar instructor Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, and so on.

Mr. DuVal will address when and how to appeal adverse 510(k) decisions, whether it be an NSE decision or an Additional Information letter. This will include a workshop in which participants will be given hypothetical situations 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) medical device requirements 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.

Mr. DuVal 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.

This seminar will be beneficial to 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; production; engineering & R&D; professionals involved with premarket notification to the FDA; R&D personnel involved in approving the design of medical devices; and sales personnel involved in approving the marketing of medical devices.

Date: Thursday, June 28 (8 AM to 5 PM PDT), and Friday, June 29, 2012 (8 AM to 12:30 PM PDT)

Location: San Francisco, CA

Venue: Grand Hyatt San Francisco
345 Stockton Street,
San Francisco, CA 94108

Registration Cost: $999 per registration

Early bird discounts: For discounts on early registrations, please click here.

Register by phone: Please call our customer service specialists at +1-650-620-3937 or email to

For more information on ComplianceOnline or to browse through our trainings, please visit our website.

About ComplianceOnline
ComplianceOnline is a leading provider of regulatory/compliance trainings for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 20,000 professionals from 3,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California and can be reached at
For more information please contact:

A Reuben Bernard
Manager of Program Marketing
2600 E Bayshore Rd
Palo Alto CA USA 94303
650-620-3937 phone
650-963-2530 fax

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