OMTEC 2015 Speaker Presentations

FDA Update: What's New in Orthopaedic Devices?

Download presentation slides, Part I and Part II [PDF]

Also see FDA's Presentation on How to Improve 510(k) Submissions

Bring your questions. FDA's Director of the Division of Orthopedic Devices and Director of the Division of Manufacturing and Quality will provide a brief update on trends they’re seeing in the orthopaedic industry, then open the floor for attendee Q&A. Moderator John Gagliardi, who has more than 45 years of R&D, quality and regulatory experience, will provide perspective on what the Agency's new initiatives and global reach mean for you and your company, domestically and around the world.

Session Takeaways
  • FDA's current priorities for orthopaedics
  • FDA's strategic initiatives over the next five years
  • Insight on topics such as metal-on-metal implants, recalls, 483s, risk management, globalization, UDI
Who Should Attend?
  • All

Speaker Bios


Mark N. Melkerson is the 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 to 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 FDA’s Tissue Policy Team.

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.

William C. MacFarland is the Director, Division of Manufacturing and Quality, within the Office of Compliance, CDRH, FDA. This division’s work relates to promoting device quality, ensuring that high risk Class III devices have sufficient quality and responding to manufacturer violations and the presence of defective devices in the market place. Mr. MacFarland has previously served in multiple management positions in CDRH as well as held positions in the device and regulatory consulting industry. He received an MBA from the University of Maryland, an M.S in Biomedical Engineering from Case Western Reserve University and his B.S in Electrical Engineering from Clarkson University. Currently he maintains a Professional Engineers license in Maryland and is an ASQ Certified Quality Engineer, Certified Biomedical Auditor, Certified Software Quality Engineer, Certified Six Sigma Black Belt, Certified Manager of Quality/Organizational Excellence and Certified Reliability Engineer.

Prepare for this Session

CDRH 2015 Guidance Document Priorities

Each year, CDRH releases a list of documents it intends to publish in the coming months. Among the topics that made this year's list:

  • Applying Human Factors & Usability Engineering to Optimize Medical Device Design (Covered at OMTEC)
  • Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
  • Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements
  • Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile (Covered at OMTEC, abstract coming)
  • Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I:
  • Evaluation and Testing (Biocompatibility) Devices Labeled as Sterile
  • UDI Q&A (Covered at OMTEC)

Review the complete list to prepare your questions for the session.

Nazia Rahman is a biomedical engineer in the Physical Medicine, Orthopaedics, Neurology and Dental Devices Branch of the Division of Manufacturing and Quality, within the Office of Compliance, CDRH, FDA. This branch of the CDRH Office of Compliance performs premarket reviews of manufacturing information, review and classification of domestic recalls, as well as evaluation of inspectional information as it relates to compliance case work. Ms. Rahman was previously a member of the Office of Compliance Quality System Working Group and is currently one of the Division’s Critical to Quality (CtQ) Process Champions. Ms. Rahman has also previously served as an operations research analyst in the Center for Drug Evaluation and Research (CDER) in FDA. She received a Master and a B.S. of Chemical and Biomolecular Engineering from Johns Hopkins University.


John Gagliardi is President of MidWest Process Innovation, where his success over the past 45 years has arisen from his practical approach to process orientation and business acuity for the medical device and pharmaceutical industries. His career has included active involvement in of research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and “business-ready” manner.

Mr. Gagliardi is a third-party auditor for ISO 13485, 21 CFR, Parts 820 and 211. He is a U.S. Agent and Official Correspondent to over 30 foreign medical device manufacturers and specification developers. MidWest Process Innovation offers training curriculums in Design Controls, Handling FDA Inspections, Purchasing Controls, CAPA, Quality Auditing, cGMP-QSR and ISO 13485:2012.