Hany Demian

26+ years of FDA experience including 22 years of CDRH premarket review of medical devices, development of consensus standards, 5 year of experience as the executive secretary for FDA's Orthopedic and Rehabilitation FDA advisory panel, and numerous management details in CDRH's: Office Device Evaluation, Office of the Science Engineering Laboratories and Office of Compliance.

Serves as a recognized technical expert, responsible for coordinating the review and analysis of consensus standards, guides, and other documents, related to the Center’s mission including those proposed by international, national, or state agencies or national and international voluntary standard-setting organizations

Effective communication skills for a variety of purposes and audiences

Extensive and proven experience in the scientific review of orthopedic and restorative medical devices and achieved a Peer Review Master Level in the Office of Device Evaluation

Peer Review Expert in PMMA Bone Cement

Numerous Publications on Bone Cements and authored the FDA guidance document on PMMA

Proven Track record of developing and leading consensus standards for medical devices in ASTM and ISO.

Current Chair of ISO TC 150 Implants for Surgery

Current Areas of Focus:
Premarket and postmarket review of medical devices, development of consensus standards. Involved in all aspects of voluntary consensus standards (VCS), including making recommendations in writing according to the existing practices and procedures and consulting with internal and external stakeholders on the appropriate use of VCS in the areas of Orthopedics, Biomaterials, Biocompatibility, and Nanotechnology, Additive Manufacturing, Tissue Engineering Medical Products (TEMPS).