title: Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.
abstract: The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.
authors: Office of Device Evaluation, Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Room 422, Silver Spring, MD 20850, USA. Binita.Ashar@fda.hhs.gov
authors: B S
authors: BS
authors: Ashar
authors: J M
authors: JM
authors: Dang
authors: D
authors: D
authors: Krause
authors: M C
authors: MC
authors: Luke
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D059685:Herniorrhaphy; D006801:Humans; D013526:Surgical Mesh; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*