To streamline the occasionally cumbersome 510(k) submission process, FDA has adopted new initiatives such as a communication timeline, and has issued new guidance documents, including substantial equivalence requirements. This session details best practices for approaching a 510(k) submission and outlines future changes to the process.
Mark N. Melkerson is Director for the Division of Orthopedic Devices. He received a Bachelor of Science in Mechanical Engineering with a biomedical option and Master of Science degree in Mechanical Engineering from Michigan State University. He joined FDA in 1987 as a reviewer in the Orthopedic Devices Branch and served as either acting branch chief or team leader from 1990-1996. Since then, he’s led multiple divisions within the Agency, including the Division of Cardiovascular and Respiratory Devices, Division of Surgical Devices and as Acting Associate Director for the Office of Device Evaluation. He was named to his current position in 2012.
Mr. Melkerson continues to participate as the one of the Center for Devices and Radiological Health (CDRH) representatives to the FDA’s Tissue Policy Team. The Tissue Policy Team, led by the Center for Biologics Evaluation and Research (CBER), has developed the HTCP (Human Cells, Tissues and Cellular and Tissue-Based Products) regulations, as well as address comments received since issuing. He has served as the co-chair of the CBER/CDRH Tissue Engineering Steering Committee since March 2005.
Mr. Melkerson participates as a liaison to a Neurological Devices Forum, the American Academy of Orthopaedic Surgeons (AAOS) Biomedical Engineering Committee, the AAOS Biologic Implants Committee, the AAOS Committee on Exhibits and the Orthopaedic Device Forum.
Constance Soves has been with FDA’s Division of Orthopedic Devices in the Office of Device Evaluation (ODE) since 2011. She has primarily served as a scientific reviewer for the Anterior Spine Devices Branch (ASDB), conducting premarket reviews for a variety of device types, including spinal fusion devices and artificial disc replacements. She has also temporarily served as the Branch Chief for ASDB and more recently acted as a Regulatory Advisor, serving as a liaison between the Division and ODE for a variety of regulatory matters. She holds a Ph.D. in Biomedical Engineering from the University of Michigan, M.S. and M.S.E. degrees in Biomedical Engineering and Mechanical Engineering, respectively, from the University of Michigan and a B.S.E. degree in Mechanical and Aerospace Engineering from Princeton University.
The New 510(k) Paradigm
By John Gagliardi
The Agency has developed “The New 510(k) Paradigm” to streamline evaluation of Premarket Notifications for the reserved Class I devices, Class II devices subject to Premarket Notification and pre-amendments Class III devices for which FDA has not yet called for PMAs. The paradigm presents device manufacturers with two approaches for obtaining 510(k) clearance. While the new paradigm maintains the traditional method of demonstrating substantial equivalence, it also presents the “Special 510(k): Device Modification” option, utilizing the Quality System Regulation, and the “Abbreviated 510(k)” option, which relies on use of guidance documents, special controls and recognized standards to facilitate 510(k) review. Use of these alternatives does not affect FDA’s ability to obtain information authorized by the statute or regulations.
Special 510(k), Device Modification: Under this alternative, a manufacturer intending to modify their own legally marketed device will conduct the risk analysis and the necessary verification and validation to demonstrate that the design outputs of the modified device meet the design input requirements. The basic content requirements of the 510(k) remain the same, and the cleared 510(k) number and a “Declaration of Conformity” with design control requirements are both added.
Device manufacturers may choose to submit an Abbreviated 510(k) when:
FDA has incentivized manufacturers by expediting the review of their submissions when they provide summary reports on the use of guidance documents and/or special controls or declaration of conformity to recognized standards.
FDA seeks agility with the 510(k) process. Read the remainder of this article to understand new developments.