A new section in final guidance on submitting premarket notifications for magnetic resonance diagnostic devices (MRDD) clarifies when device modifications trigger the need for a new 510(k).
Not all modifications to a previously cleared MRDD require a new 510(k). Rather, a 510(k) is needed for a modification that could significantly affect the safety or effectiveness of the device, or a major change or modification in the intended use of the device.
For example, the FDA said changes to the main static magnetic field, gradient system, and radio frequency (RF) body transmit coils generally require a new 510(k). Introducing a new RF receive coil also generally requires a new 510(k), while modifying an existing RF receive coil may or may not depending on the circumstances, the guidance says.
Changing the transmit architecture of other types of transmit coils generally requires a new 510(k), but changing the material type, formulation, chemical composition, or material processing for non-patient contacting coil housing materials generally does not.
Changes to pulse sequences and protocols may or may not require a new 510(k).
The guidance finalizes a draft document issued on July 14, 2015, and supersedes guidance issued in 1998.