Facilitating the Approval Process of Anti-Infective Technologies and Advancing Them to the Market Insights from an FDA Workshop on Orthopaedic Device-Related Infections


Goh G. S., Tornetta P., PARVİZİ J.

JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME, cilt.103, sa.15, 2021 (SCI-Expanded) identifier identifier identifier identifier

  • Yayın Türü: Makale / Editöre Mektup
  • Cilt numarası: 103 Sayı: 15
  • Basım Tarihi: 2021
  • Doi Numarası: 10.2106/jbjs.21.00007
  • Dergi Adı: JOURNAL OF BONE AND JOINT SURGERY-AMERICAN VOLUME
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Biotechnology Research Abstracts, CAB Abstracts, CINAHL, EMBASE, MEDLINE, Public Affairs Index, SportDiscus, Veterinary Science Database
  • Acıbadem Mehmet Ali Aydınlar Üniversitesi Adresli: Hayır

Özet

Orthopaedic device-related infection is one of the most devastating complications in orthopaedic and trauma surgery. With increasing life expectancies as well as the lifelong risk of bacterial seeding on an implant, the prevention and treatment of device-related infection remains an important area for research and development. To facilitate information exchange and enhance collaboration among various stakeholders in the orthopaedic community, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) organized an inaugural workshop on orthopaedic device-related infections, exploring the regulatory challenges that are faced when proceeding from the bench level to marketing and clinical implementation of new infection-control devices and products. This article summarizes the perspectives of scientists, clinicians, and industry partners on the current regulatory approval process for orthopaedic anti-infective technologies as well as the proposed strategies to overcome these regulatory challenges.