Better Late Than Never: FDA Published FR Notices For De Novo Classifications Dating As Far Back as 2013

July 7, 2025By Véronique Li, Senior Medical Device Regulation Expert

In late June, FDA published five Federal Register notices that caught our eye, particularly for the dates the classifications were first applicable.

Each notice listed the action as “Final amendment; final order” rather than “Final order.” This editorial change began in December 2019 to indicate that the document amends the Code of Federal Regulations.

Below we summarize the device type and original applicable classification date for each of these notices:

Device TypeOriginal Applicable Classification Date
Muscular dystrophy newborn screening testDecember 12, 2019
Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignanciesDecember 21, 2018
Lysosomal storage disorder newborn screen test systemFebruary 3, 2017
Herpes simplex virus nucleic acid-based assay for central nervous system infectionsMarch 21, 2014
Cream for x-ray attenuationMay 9, 2013

Note that two of the above classifications date back well over a decade, stretching back to the Obama administration. It’s not clear why there was a delay but better late than never.

Categories: Medical Devices