• Regulatory NewsRegulatory News

    FDA explains when device 'servicing' becomes 'remanufacturing'

    At what point does manipulation or repair of a medical device cross the line from “servicing” to “remanufacturing?” A new draft guidance from the US Food and Drug Administration (FDA) provides a set of considerations to aid in determining into which category actions performed on devices should fall.   The new draft guidance “helps clarify whether activities performed on devices are likely remanufacturing,” wrote FDA’s Center for Devices and Radiological Health (CDRH) i...
  • Regulatory NewsRegulatory News

    Device Firms to Inform New FDA Framework on Servicing

    Following a decision against extending regulatory requirements to third-party device servicers, the US Food and Drug Administration (FDA) is seeking feedback to inform upcoming guidance on the distinction between servicing and remanufacturing.   The agency laid out its initial thoughts about certain concepts, including guiding principles, a software-based complementary approach and labeling considerations, in a new white paper issued on Tuesday to guide the discussions...