MCRA experts Mehdi Kazemzadeh-Narbat and Kevin McGowan recently published a manuscript with other key authors entitled “Advances in antimicrobial orthopaedic devices and FDA regulatory challenges.” Read the abstract below, and access the full manuscript here.
Abstract
Implant-associated infections, caused by the formation of biofilms especially antibiotic resistant organisms, are among the leading causes of orthopaedic implant failure. Current strategies to combat infection and biofilm focus on either inhibiting bacterial growth or preventing bacterial adherence that could lead to biofilm creation. Despite research on developing numerous antimicrobial orthopaedic devices, to date, no robust solution has been translated to the clinic. One of the key bottlenecks is the disconnect between researchers and regulatory agencies. In this review, we outline recent strategies for minimizing orthopaedic implant-associated infections. In addition, we discuss the relevant FDA regulatory perspectives, challenges. We also highlight emerging technologies and the directions the field that is expected to expand. We discuss in depth challenges that include identifying strategies that render implants antibacterial permanently or for a long period of time without the use of antimicrobial compounds that could generate resistance in pathogens and negatively impact osseointegration.
Meet MCRA’s Experts
Kevin McGowan, Ph.D., Vice President, Regulatory Affairs, leads MCRA's biologic, human cell and tissue, and combination product US regulatory affairs team, as well as contributing to MCRA's orthopedic and spine regulatory groups. Dr. McGowan's work at MCRA focuses primarily on novel technologies and therapeutics for which clinical data is necessary. Learn more about Kevin McGowan here.
Dr. Mehdi Kazemzadeh-Narbat is a Director, Regulatory Affairs at MCRA, and former FDA medical device lead reviewer and acting team lead who has worked on a wide range of products through hundreds of FDA reviews. Beside his almost 5 years medical device regulation experience at FDA, he was also a consultant and subject matter expert for biocompatibility, chemical characterization and toxicological risk assessment, animal study and antimicrobial associated devices in the Agency. Dr Kazemzadeh-Narbat is experienced in approval processing and clearance of 510(K), PMA, De Novo, IDE, Q-submissions, Combination Products, Breakthrough device regulations and Clinical Evaluation Report (CER) submissions. Dr Kazemzadeh-Narbat is also a Biomaterials Scientist with experience in design and characterization of various biomaterials for Medical Products, and is experienced in in-vitro, ex vivo, and in vivo (Pre-clinical Animal Models). Dr. Kazemzadeh-Narbat has published multiple science, and regulatory papers and has developed two FDA Guidance documents (e.g., Google Scholar, ODT Bone Graft, ODT Antimicrobial). Learn more about Mehdi Kazemzadeh-Narbat here.