The FDA States, WSI Systems Are Not Class I Exempt

By guest author Amanda Lowe of Digital Pathology Consultants, LLC

The FDA Hematology and Pathology devices advisory panel meeting, open to the public and being held in Gaithersburg, Maryland, began this morning to discuss Whole Slide Imaging (WSI) and its implications when used for primary diagnosis of surgical pathology.  In the audience were digital pathology industry professionals and advocates from all over the country who convened to hear industry guest speakers, FDA personnel, and the advisory panel candidly discuss the regulatory future of WSI systems. 

The initial presentation given by Tremel Faison, a Scientific Reviewer for the FDA, set the tone for the meeting whereby she informed the public and panel that WSI systems could not be Class I exempt, like a microscope, and are therefore subject to premarket requirements.  The reason a WSI device will not be considered exempt is, as defined by 21 CFR 864.9 limitations, a WSI device is considered to be different fundamental scientific technology and IVD intended for use in diagnosis. 

An example was given to reinforce this point comparing a scalpel to its laser equivalent.  A scalpel could be classified as Class I, but when laser technology was introduced to perform the same type of activity as a scalpel, the technological advancement and modifications tripped the limitation of Class 1.  In addition, it was reasonable to assume that the laser technology could alter the safe and effective use of the device.  The same is true for Whole Slide Imaging.  WSI trips the limitation of Class I, as described above, and impacts the safety and effectiveness of microscopy.    Although an impact to the safety and effectiveness of microscopy may occur, there has been no indication that the impact is harmful.  In fact it is quite the opposite.  Many points were made today, throughout the 10 hours of discussion, which endorsed the use of WSI for primary diagnosis in surgical pathology. Moreover, the FDA recognizes that the technological advances associated with WSI make its use a reality.

Stay tuned! Additional posts with news from the FDA advisory committee meeting will be available in the coming days.