FDA draft guidance helps manufacturers with premarket notifications

The Food and Drug Administration (FDA) has published a new draft guidance to help manufacturers of magnetic resonance diagnostic devices (MRDDs) submit their 510(k) premarket notification applications.

MRDDS are considered Class II medical devices, so premarket notification and “agency determination of substantial equivalence” are required prior to marketing.

The new information applies to more than just brand new devices, the FDA explained.

“This draft guidance document is applicable to premarket notifications for magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) systems, components, and modifications to systems and components which have a significant impact on safety or effectiveness of the magnetic resonance diagnostic device and trigger the need for premarket review of a 510(k) prior to marketing,” the FDA wrote. “The information in this guidance document is also applicable to the MRI system components of dual-modality devices, such as PET/MRI systems.”

The guidance covers relevant standards, how a device’s Indications for Use (IFU) should be described within the 510(k) document, how to properly evaluate a device’s safety, and other information that will help manufacturers with their applications.

The FDA is asking for public comments to be sent by October 13. Once this draft guidance becomes final, it will replace the FDA’s previous guidance on this subject, from 1998.