FDAnews Device Daily Bulletin

Devices With BPA Added to FDA’s ‘Hot Topics’ List

Oct. 8, 2008
Medical devices containing the chemical bisphenol A (BPA) — such as dialysis tubing, blood oxygenators and dental sealants — are now on the FDA’s radar and soon will become an area of concern for consumers and industry, an expert says. Until recently, devices have not been part of the conversation of whether BPA levels in FDA-regulated products are safe. But now that an evaluation examining migration of BPA from food contact materials has been drafted, the agency plans to publish a document assessing the safety of BPA exposure from regulated devices, biologics and pharmaceuticals, FDA spokesman Michael Herndon said.