Document Offers Guidance on Resorbable Adhesion Barriers

Originally Published MDDI September 2002

NEWS & ANALYSIS

Jim Dickinson

FDA's Center for Devices and Radiological Health (CDRH) has issued a guidance document that addresses resorbable adhesion-barrier devices used in abdominal and pelvic surgery. The guidance is based on FDA's analysis of published scientific information, interaction with manufacturers, and input from FDA's Medical Device Advisory Committees. It discusses the development of preclinical and clinical information for an investigational device exemption (IDE), premarket approval (PMA), or product development protocol application.

As a significant-risk device, resorbable adhesion barriers require an IDE application, CDRH says. This document provides guidance for the preparation of such an application, as well as for the development of valid scientific evidence to support PMA applications for adhesion barriers resorbed within 30 days of placement into the pelvic cavity.

Copyright ©2002 Medical Device & Diagnostic Industry