Welcome

We are pleased to welcome Elaine C. Messa in August as Director, Medical Device Quality Systems and Compliance Practice.  Ms. Messa has more than 30 years of experience in the field at both FDA and as a consultant to industry leaders.  At FDA, Ms. Messa was Director of the Los Angeles District which is the district responsible for the largest import operations and medical device workload in the US. Contact: elaine.messa@becker-consult.com.

Ms. Messa brings the same degree of prominent depth and experience as our existing Pharmaceutical Quality and Compliance Practice directed by Robert A. Rhoades. Contact: bob.rhoades@becker-consult.com.

Ms. Messa’s Biography

September 21, 2008 - The Gray Sheet Announcement:

Becker & Associates taps Elaine C. Messa as Director, Medical Device Quality Systems and Compliance.  As former director of FDA’s Los Angeles field district office, Messa oversaw the largest import operations and medical device workload in the agency, the health care consulting firm says. Messa, who has also chaired CDRH’s field committee, left FDA in 1999 to join Quintiles Transnational.  At Becker, Messa is charged with expanding the firm’s compliance practice, where she w ill focus on enforcement action responses and international supply-chain risk management.

Invited Presentations

Phil Phillips, Medical Device Practice Director and former CDRH Deputy Director, will present at the Johnson & Johnson Regulatory Affairs Summit held in Newbrunswick, NJ on October 1, 2008.

Robert A. Rhoades presented at a preconference workshop entitled "US Regulatory Essentials" for the annual Regulatory Affairs Professional Society (RAPS) meeting on September 14, 2008. This preparatory worshop, targeting individuals working towards their RAC, specifically discussed compliance and enforment action. Boston, MA. Presentation.

Robert A. Rhoades and Latham & Watkins LLP taught an interactive workshop "FDA Compliance Inspections Outside the U.S." in Hamburg, Germany on June 19-20, 2008 and in Dublin, Ireland on June 24-25, 2008. Brochure.

Phil Phillips and Kristin Zielinski discussed "Intended Use, Indications for Use and Claims; Navigating Uncharted Waters in the Device Industry" at the Advertising, Promotion and Labeling Conference hosted by the Regulatory Affairs Professional Society (RAPS), May 13, 2008, Baltimore, Maryland. Presentation.

Phil Phillips and Ronda Balham presented "Food and Drug Law 101 and Introduction to Medical Device Law and Regulation Workshop: Understanding How FDA Regulates the Medical Device Industry " at the Center for Devices and Radiological Health (CDRH), May 12, 2008.

Dr. Ronda Balham joined AdvaMed in China to provide training on FDA medical device regulations at the Joint Commission on Commerce and Trade, Pharmaceutical and Medical Devices Task Force, Seminar on Key Issues in Medical Device Regulation, April 9-11, 2008, Guilin, China.

Phil Phillips discussed "How Far Can Medical Device Firms Deviate from FDA's Cleared Indications For Use?" at the Medical Device Regulatory, Reimbursement and Compliance Congress, March 27, 2008, at Harvard University.

Kristin Zielinski presented "Postmarket Requirements for
510(k)", "System 510(k) Requirements and Strategy" and the "FDA Process of Appeals" at Informa Life Sciences' symposium on Navigating the FDA Regulatory Framework in Amsterdam, January 24, 2008.

Phil Phillips moderated the session on Postmarket Surveillance with speakers Mark Heller, Susan Alpert, MD, PhD, and Donald J. St. Pierre at the Fiftieth Annual FDLI & FDA Educational Conference: "Cutting Edge Innovations: Balancing Safety and Rewards for Healthier Lives" in North Bethesda, MD, April 13, 2007. See www.fdli.org. Brochure.

Phil Phillips presented at the Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress, on the campus of Harvard University, March 29, 2007. Brochure.

Dr. Ron Ginor discussed "From Concept to Commercialization: The Evolution and Maturation of The Israeli Life Science Sector" at Israel – A Pioneer in the Life Science Industry, hosted by the Government of Israel Economic Office in Houston, Haynes and Boone LLP, and the Health Industry Council, on January 29, 2007 in Dallas, TX. Brochure.

Kristin Zielinski directed a workshop in London, England on November 6, 2006, 2006: "Introduction to US FDA Regulation of Medical Devices" at IBC's 12^th Course on Medical Device Regulations. See www.ibc-lifesci.com/meddev. Brochure.

Awards

Dr. Ryung Suh was appointed to serve on the American Medical Association CPT Advisory Committee through June 2010. (July 2007).

Dr. Ryung Suh received the Donald F. Hagen Award, from the Association of Military Surgeons of the United States, presented for his proven commitment to the health and safety of our nation’s fighting men and women, his actions in humanitarian assistance and civic action projects, and in prevention and public health programs (November 2006).

Dr. Ryung Suh received the Jordan Fieldman MD Award, presented by the American Medical Association for achievements in medical and patient care issues and patient advocacy efforts (June 2006).

Dr. Ryung Suh received the American Medical Association Excellence in Medicine Leadership Award, presented in association with the Pfizer Medical Humanities Initiative (March 2006).

Philip J. Phillips received the FDA Commissioner's Leveraging/Collaboration Award for his participation in Counterterrorism and Emergency Preparedness activities at FDA. (June 2005).

Dr. Karen M. Becker was named a finalist for the Ernst & Young Entrepreneur of the Year® 2005 Awards in the Greater Washington Area. (May 2005).

Selected Publications

Phillips PJ, Zielinski KM.  2008. Claims and 510(k) Requirements: An Area of Uncertainty for Medical Devices.  FDLI. Reprint.

Gibson BR, Suh R, Tilson HH .  The U.S. Drug Safety System: Role of the Pharmaceutical Industry. Pharmacoeconomics and Drug Safety. In press.

Baetz JA, Tuskey CL.  2007. Medical Device Reuse in the US.  Regulatory Affairs Journal (Devices) 15:3-8. Reprint.

Tilson HH, Gibson BR, Suh R .  2006. FDA and the Drug Safety System: The Role of the Pharmaceutical Industry.  Commissioned by the Institute of Medicine Committee on the Assessment of the U.S. Drug Safety System.

Becker K, Whyte J. (eds.). 2005. Clinical Evaluation of Medical Devices. Principles and Case Studies, 2nd Ed. Towata, NJ: Humana Press. See www.humanapress.com.

Phillips PJ, Lynne JC.  2005. Unnecessary 510(k) Fillings: A Waste of Industry and FDA Resources.  Regulatory Affairs Journal (Devices) 13:341-345. Reprint.

Zielinski KM, Payne KH. 2004. The De Novo 510(k) Process - How to Down-Classify Novel Devices Automatically Placed in Class III.  Regulatory Affairs Journal (Devices) 12:73-78. Reprint.

Becker KM, Flannery EJ, Henteleff TO. 2003. Scientific Dispute Resolution: First Use of Provision 404 of the Food and Drug Administration Modernization Act of 1997. Food and Drug Law Journal 58:211-222. Reprint.

Becker KM. 2002. A Primer on Medical Device Regulation in the U.S. Part II of II. Premarket Approval Applications (PMAs). Regulatory Affairs Journal (Devices) 10:103-109. Reprint.

Press

Comments submitted to FDA by Phil Phillips, Medical Device Practice Director and former CDRH Deputy Director, for a guidance on 510(k) submissions of devices or combination products with antimicrobial agents were reported by The Gray Sheet, September 1, 2008. See www.thegraysheet.com. Comments.

Comments by Phil Phillips defending FDA while it faces new challenges were published in The Regulatory Affairs Journal, Jan/Feb 2008. Reprint.

Comments by Phil Phillips on the challenges FDA continues to face were published by Medical Device & Diagnostics Industry Magazine, May 2006. See www.devicelink.com/mddi. Reprint.

Remarks by Phil Phillips on the controversial CDRH approval of Cyberonics neurostimulation device were reported by The Gray Sheet, February 27, 2006. See www.thegraysheet.com.

Q&A with Phil Phillips on "The Modernization of ODE." Medical Device & Diagnostics Industry Magazine. August 2005. See www.devicelink.com/mddi. Reprint.

Remarks by Dr. Karen Becker on FDA mandated post-approval studies were reported by The Gray Sheet, February 23, 2004. See www.thegraysheet.com.

Of Interest

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