SABIC Innovative Plastics has created a comprehensive healthcare product policy with the intent of supporting OEMs in achieving regulatory compliance for their healthcare applications.
SABIC’s healthcare product policy is designed to help achieve marketing approval and commercialization for a range of medical devices. The service ensures consistency and biocompatibility of its healthcare-grade materials so that customers can be confident that the material they choose for a medical device meets FDA and European regulations.
“In this industry, any material change can cause trouble,” says Tom O’Brien, SABIC’s product marketing manager, healthcare. “Our customers look to SABIC to help them comply with regulations imposed by FDA, European Food Safety Authority (EFSA), and other agencies to enhance patient safety.”
O’Brien says that the solution was to actively develop an industry-leading healthcare product policy to simplify regulatory compliance, both during marketing approval and throughout the device life cycle. “Preassessing the biocompatibility of our healthcare products helps speed up marketing approval in the regulatory process, while internal controls and change management help ensure consistent quality and reliability,” he says.
The product policy provides the following services:
? Preassessment of resin biocompatibility according to ISO 10993 or USP Class VI standards.
? Food contact compliance for most healthcare products.
? FDA drug or device master file listing, with a letter of authorization provided if needed.
? Products subject to formula lock and change management process.
? Healthcare product nomenclature for easy identification.
“Management of change is really what is key to industry,” O’Brien says. “We can’t say we’re never going to change materials—some of that is out of our control—but we will give our customers six months’ notification and can provide them with up to 18 months of supply if they request it.” O’Brien says that the long lead time gives OEMs the ability to go through the regulatory process for materials change requests without having to stop production. Applications that are designed to remain implanted longer than 29 days are not supported by the product policy. —Heather Thompson