ASCP, API Join Forces on FDA Digital Pathology Comments

ASCP has teamed up with the Association of Pathology Informatics to comment on a recent Food and Drug Administration Notice making permanent certain regulatory flexibilities. 

In the notice, the FDA stated that the Department of Health and Human Services is permanently exempting seven class I devices from the 510(k) premarket notification requirement and is also proposing to exempt an additional 83 class II devices and one unclassified device class from the 510(k) requirement. The FDA also stated that the Department is seeking comments on whether premarket review should be permanently waived for some or all of these 83 devices as well as ways to improve the 510(k) premarket notification program. A number of the proposed changes affect the agency’s handling of digital pathology products.

In our comments, ASCP, API and others concurred that FDA oversight of digital pathology display products, though varying levels of support were provided for FDA oversight over other digital pathology devices. To access a copy of the comments, click here.