Quicker review times are an expected result of user fees, but in the device industry they provide a valuable resource as the sector employs technological advances as part of its submissions.
If user fees work for prescription drugs, they can work for medical devices. That is the thinking behind the user-fee program for medical devices approved last October. Patterned after the popular prescription drug user-fee program that brought increased resources to the Food and Drug Administration as a way to help it achieve greater efficiency, the program for medical devices has a much larger goal than reducing regulatory review times.
The objective is to provide the agency with the necessary resources to address increasingly innovative and complicated medical devices stemming from technological advances in genomics, proteomics, and nanotechnology. While the real impact is not expected to be felt immediately, experts say, these advances are likely to pose significant challenges for regulators and manufacturers and could well result in a higher level of regulatory scrutiny. Increased FDA efficiency will be needed to get these products through the approval process and to market as quickly as possible…
A Snapshot of the Device Industry
Medical Device Facts
A Different World
Experts on this Topic
Stephen A. Bent. Chair of the firmwide life-sciences business team, Foley & Lardner, Washington, D.C.; Foley & Lardner is a full-service, international law firm with leading practices in intellectual property and the life sciences. For more information, visit foleylardner.com.
Amit Bohora. Medical device practice leader, Frost & Sullivan, San Antonio; Frost & Sullivan is an international marketing consulting company that monitors a comprehensive spectrum of markets for trends, market measurements, and strategies. For more information, visit frost.com.
Neal Fearnot. President, Med Institute Inc., West Lafayette, Ind.; Med Institute was established to identify and develop new medical product concepts and is a subsidiary of privately held Cook Group, a designer, manufacturer, and global distributor of minimally invasive medical-device technology for diagnostic and therapeutic procedures. For more information, visit cookgroup.com.
Michelle Kile. Partner, Intellectual Property and Life Sciences, Foley & Lardner, Washington, D.C.; Foley & Lardner is a full-service international law firm, with leading intellectual property and life-sciences practices. For more information, visit foleylardner.com.
Mark B. Leahey. Executive Director, Medical Device Manufacturers Association (MDMA), Washington, D.C.; MDMA is a national trade association that represents more than 160 independent manufacturers of medical devices, diagnostic products, and healthcare information systems. For more information, visit medicaldevices.org.
Natasha Leskovsek. Associate, Heller Ehrman White & McAuliffe LLP, Washington, D.C.; Heller Ehrman is a full-service law firm, representing a wide range of industry leaders. For more information, visit hewm.com.
Ed March. Senior consultant, AAC Consulting Group Inc., Rockville, Md.; AAC Consulting Group, a subsidiary of Kendle International Inc., is a full-service regulatory consulting firm that provides regulatory compliance and validation services to the pharmaceutical and medical-device industries. For more information, visit aacgroup.com.
Richard Naples. VP of regulatory submissions, reimbursement, and government affairs, Roche Diagnostics, Indianapolis; Roche Diagnostics, a division of Roche, is a leading provider of diagnostic systems and decision-oriented health information. For more information, visit roche-diagnostics.us.
Harvey Rudolph, Ph.D. Global Program Manager for Medical, Underwriters Laboratories Inc., Bethesda, Md.; UL with headquarters in Northbrook, Ill., is an independent, nonprofit product safety testing and certification organization and a recognized third-party medical-device reviewer. For more information, visit ul.com/medical.
Michael Sweeney. General Partner, InterWest Partners, Menlo Park, Calif.; InterWest Partners is a leading diversified venture capital firm. For more information, visit interwest.com.