Understanding FDA’s Latest Rules on Medical Device Maintenance
The FDA's new guidance distinguishes between servicing and remanufacturing of medical devices, urging vigilance and regulatory adherence.
The FDA's new guidance distinguishes between servicing and remanufacturing of medical devices, urging vigilance and regulatory adherence.
In this UpFront column, 24x7 Magazine chief editor Keri Forsythe-Stephens discusses one of the most contentious topics in the HTM industry—the FDA’s bid to distinguish between remanufacturing and servicing—and shares the agency ’s latest move that could have far-reaching implications.
The FDA's new guidance distinguishes between servicing and remanufacturing of medical devices, urging vigilance and regulatory adherence.