MASSDEVICE ON CALL — Consumer advocacy group Consumers Union submitted a letter to U.S. healthcare regulators, offering more than 11,000 signatures in favor of more stringent oversight of implantable medical devices.
CU urged the FDA to require that all high-risk medical implants undergo clinical testing vie the agency’s premarket approval process, rather than allowing them through via the less-stringent 510(k) pathway, which requires only that a device demonstrate that it’s "substantially equivalent" to a product already cleared by the FDA.