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									 Live Webinar on : Update On and Look Ahead At FDA’s Changes to the 510(k) Process
 Wednesday, July 11, 2012 duration : 12:30 to 14:00 PM EDT


                                          In 2010, FDA issued a report on the changes it plans to
                                          make to the 510(k) process to address regulatory,
                                          industry, and consumer concerns and 2011 and 2012
                                          have been marked by the agency’s progress in
                                          implementation of these changes. In the past year, the
                                          agency published a draft guidance document that
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                                          revises and clarifies the agency’s longstanding policies
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                                          regarding when a new 510(k) submission will be
                                          required for changes being made to an existing device
                                          and another draft guidance document which creates a
                                          second alternate de novo pathway for devices found to
                                          be not substantially equivalent (NSE) at the end of the
                                          510(k) process. FDA has also issued a draft guidance
                                          document which would change and clarify other
                                          aspects of the agency’s 510(k) program in an attempt
                                          to foster more consistency across 510(k) reviews,
                                          coupled with training and certification for FDA device
                                          reviewers. Other 510(k)-related guidance documents
                                          have issued as well.


                                          Why should you Attend :
Live ( Single registration ) : $189.00
                                          As the vast majority of moderate risk medical devices
Group ( Max 10 Attendee): $249.00
                                          are cleared for marketing through the 510(k) process,
On Demand (Recording available):$289
                                          these changes can have a substantial impact on the
Get Training CD : $399
                                          way industry does business. This presentation will
Who will benefit                          discuss the background behind FDA’s decision to
                                          modify the 510(k) process, outline the progress it has
Who will benefit: (Titles)                    made in 2011and 2012 to implement these changes,
                                              and take a look at what changes are yet to come in
 Representatives of manufacturers            2012 and beyond.
and marketers of 510(k) medical
devices, including in-house counsel,          Our Experts :
outside FDA counsel, regulatory affairs
personnel, and regulatory consultants.        Mr. Uldriks, counsel at OFW Law, was born in Battle
                                              Creek, Michigan. He began his 30+ year career as an
                                              investigator at FDA in 1978. He graduated with his B.A. in
                                              1973 from Albion College, his Master of Divinity from
Areas Covered in the Session:                 Boston University in 1976, and his J.D. from Suffolk
                                              University Law School in 1986. He was admitted to the
                                              Massachusetts Bar in 1986 and the DC Bar in 2011. He
                                              held a number of positions at FDA, such as an investigator
                                              in FDA’s New England office, in the Office of the
                                              Commissioner in Legislative Affairs and in the Center for
                                              Devices and Radiological Health (CDRH), where he served
                                              as CDRH's Associate Director for Regulatory Guidance and
                                              Government Affairs. He helped to guide CDRH to
                                              develop and implement various medical device related
                                              amendments to the Food, Drug, and Cosmetic Act,
                                              regulations and guidance documents. For years he has
                                              trained FDA staff on medical law and has been a featured
                                              speaker at many professional conferences involving FDA's
                                              medical device program.

                                              About Speaker

                                              Mr. Phelps is a principal at OFW Law. Mr. Phelps advises
                                              companies on compliance with Food and Drug
                                              Administration (FDA) law and regulations, with focus on
                                              matters related to medical devices and biologics as well
                                              as those affecting Clinical Investigators. This includes:

                                          ·    Assistance in the preparation of Premarket Approval
                                              Applications (PMAs), Premarket Notifications (510(k)s),
                                              and Investigational Device Exemption (IDE) Applications;
                                          ·    Advice, training, and assistance with matters concerning
                                              the Quality System Regulation (QSR) and the Medical
                                              Device Reporting (MDR) Regulation;
                                          ·    Assistance with responding to and resolving issurelating
                                   o FDA establishment inspections;
                                   o Forms FDA-483 (Inspectional Observations);
                                   o Warning Letters;
                                   o njunctions;
                                   o Import/Export of FDA-regulated products;
                                   o Product labeling.
                                   ·    Assisting Clinical Investigators and IRBs with compliance,
                                       enforcement, and training issues.
                                   ·    Advising companies on the impact of FDA law on
                                       business transactions and agreements.
                                   ·    Development of specially tailored plans to bring medical
                                       devices to market based upon client needs and goals; and
                                   ·    Assistance in filing or responding to trade complaints.
                                       In addition, Mr. Phelps' practice includes advising
                                       companies on matters related to compliance with Drug
                                       Enforcement Administration (DEA) law.
                                       Mr. Phelps was born in Washington, D.C. , received his
                                       B.A. from Trinity University in 1987, and his J.D. c um
                                       laude from George Mason University School of Law in
                                       2001. He was admitted to the Virginia Bar in 2001. Prior
                                       to joining the firm, Mr. Phelps was a U.S. Army Officer
                                       who served multiple tours at Fort Bragg, NC and was
                                       responsible for the conduct of multiple counter-narcotic
                                       operations in South and Central America
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