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October 16th, 2012

The Difference Between Success and Failure in the Medical Device Business

Selecting Alternative Regulatory Pathways to Market


Orange County Regulatory Affairs Discussion Group

You are Invited to an Evening Meeting

The Difference Between Success and Failure in the Medical Device Business: Selecting Alternative Regulatory Pathways to Market


Wednesday, Oct. 24, 2012


6:00 pm – 8:00 pm  



Alcon Laboratories
15800 Alton Pkwy
Irvine CA 92618


Presented by:

Evan L. Rosenfeld, MD JD FCLM 

Vice President for Medical and Scientific Affairs

Theorem Clinical Research


Program Manager: 

Christopher Swanson, Regulatory Affairs Specialist 

Advanced Sterilization Products 


$50 OCRA Members 

$100 Non Members (includes OCRA Membership) 

$25 Students/Government
Free for Alcon Employees
(email Rob Fleming to be added to the list:  


Synopsis of the Session:

The choice and availability of a more attractive, alternative regulatory pathway to the U.S. marketplace often can make the difference between a medical device manufacturer’s financial and market success or failure. Thus, a medical device sponsor’s essential business viability – or lack thereof – can depend directly on both the existence and the successful use of such an unconventional approach to FDA, especially for young companies in their early stages of business development.

In a 1997 law, the “de novo downclassification process” was created to assist companies to bring to market their new, novel, and by definition “Class III,” medical devices by allowing clearance under the much less burdensome 510(k) regulatory route, instead of having to go down the difficult route of premarket approval (“PMA”). Ultimately, the ability to submit a far simpler 510(k) premarket application rather than having to go the PMA route can reduce time to market entry by several years and decrease up-front monetary costs by literally hundreds of thousands of dollars. The de novo process allows FDA to more quickly and more simply clear a new device for sale on the U.S. market despite the nonexistence of a predicate device to which the “new” device might be found substantially equivalent and, thus, which ordinarily requires a PMA. The de novo process instead only requires the manufacturer to develop and implement certain, far less expensive “special controls” that better guide the consumer (including physicians and/or patients) that are aimed at enhancing overall patient safety and minimizing potential device-related dangers to the public.

The current presentation includes a brief historical overview of the de novo process and its evolution to present day, provides a summary of companies that have used the de novo process successfully, outlines the timeline for this process, discusses the changes to the de novo process that have been implemented most recently, and analyzes the benefits to and the challenges still facing the medical device industry’s use of the de novo downclassification route for product regulation and ultimate entry to the U.S. market. Also to be discussed are the Agency’s recent parallel activities to – on its own initiative – downclassify several device types, as support for FDA’s real moves to assist device manufacturers to move their innovative products more expeditiously through the market clearance process and onto the U.S. sales market.

About the Speaker:

Evan L. Rosenfeld, MD JD FCLM

Vice President for Medical and Scientific Affairs

Theorem Clinical Research, Dallas TX 

Dr. Rosenfeld is in charge of leading the company in its efforts to assist clients with their complex strategic clinical study design, implementation, completion, and review/interpretation of such trial results, from the various perspectives of:
*  Optimizing regulatory pathways; Outcomes of governmental reviews for market clearance or approval; Post−clearance/approval market positioning (relative to potential and/or existing competitors); Long−term safety outcomes and assessments; and Overall scientific/clinical rigor of the clinical studies under advisement.

*  Involvement at all stages of clinical trials, ranging from first−in−man and feasibility studies (to confirm and support continued product development efforts) to post−market trials (e.g., to support reimbursement activities, ongoing safety and efficacy monitoring, etc.).

*  Involvement in all company business units, with predominant focus on medical device clients, including those with device−drug combination and in vitro diagnostic (IVD) products.

*  Providing senior oversight on large or complex ongoing projects to ensure quality, delivery and ongoing client satisfaction; Identify client needs and develop creative solutions for projects, leveraging expertise, operational capabilities and technologies.

* Maintaining a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner. * Building thought leadership by participating in conferences, events, and client presentations. * Leading client meetings, conduct capabilities presentations, and leverage personal networks and Business Unit expertise.

He has his MD from Medical College of Virginia, his JD from University of Pennsylvania Law School and a BA in Biology from Harvard.

 Click here to download the registration form 



For an immediate receipt and confirmation email, register on line at OCRA’s website,


If paying by personal or company check:

Please submit the online registration form. Mail your check made payable to OCRA to the following address:


Orange County Regulatory Affairs Discussion Group

5319 University Dr., Suite 641, Irvine, CA 92612

Tel:     949-387-9046

Fax:     949-266-8461 or 949-387-9047



OCRA’s non-profit Federal Tax ID# 33-0630455


NOTE: We will ask for a credit card payment for any checks not received by the meeting date

Cancellation Deadline:

For a refund, please cancel by replying to this email by October 17, 2012


If you have reserved a space but do not attend, your payment MUST be remitted.



Alcon Laboratories 

15800 Alton Pkwy 

Irvine CA 92618



It is recommended that you look up driving directions from your own starting point.  


Directions from LA:
Take I-405 S to Exit 3 (in Irvine).  Take ramp right and follow signs for Shady Cyn Dr/Sand Cyn Ave.  Turn left onto Sand Canyon Ave.  Turn right onto Alton Pkwy.  Go 0.9 miles and arrive at 15800 Alton Pkwy, Irvine.  The last intersection is Telemetry.  (If you reach Banting, you’ve gone too far.)

Directions from San Diego:
Take I-5 N to Exit 94B.  Take ramp right and look for signs for Alton Pkwy. Turn left onto Alton Pkwy.  Make a u-turn at Telemetry and arrive 15800 Alton Pkwy. (If you reach Banting, you’ve gone too far.) 


Kimberly Syre
Attention To Detail
5319 University Dr., Suite 641
Irvine, CA 92612
Tel: 949-387-9046
Fax: 949-387-9047
Alt Fax: 949-266-8461


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