+39 06 5782665
contact@donawa.com

FDA Finalizes Guidance on UHMWPE in Orthopedic Devices

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration (FDA) has published final guidance on the use of various types of ultrahigh molecular weight polyethylene (UHMWPE) in orthopedic devices.

The 18-page guidance finalizes a draft version released for comment in 2016 and provides recommendations for characterizing and testing Class II and III orthopedic devices that contain UHMWPE materials for various types of submissions including premarket notifications (510(k)), de novo requests, premarket approval (PMA) applications, humanitarian device exemptions (HDE) and investigational device exemptions (IDE).

Within the guidance, FDA describes the characteristics of four types of UHMWPE, including conventional UHMWPE, highly crosslinked UHMWPE, highly crosslinked UHMWPE containing antioxidants and nonconventional UHMWPE and what information is recommended to be included in submissions for each type of material.

This website uses cookies and asks your personal data to enhance your browsing experience.