FDA Posts Form To Report Device Reg Misconduct, Such As Off-Label Promotion

Individuals can now post allegations that a company is not adhering to regulations governing medical devices to an electronic form on FDA's website, which the agency hopes will help bring to light issues such as off-label promotion about which it otherwise might not have been aware. Submissions may be submitted anonymously, but the agency said providing contact information would help FDA in the event more information is needed to take regulatory action. “Allegations of regulatory misconduct may include failure to...