Better Late Than Never: FDA Published FR Notices For De Novo Classifications Dating As Far Back as 2013
July 7, 2025In 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 Type | Original Applicable Classification Date |
| Muscular dystrophy newborn screening test | December 12, 2019 |
| Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignancies | December 21, 2018 |
| Lysosomal storage disorder newborn screen test system | February 3, 2017 |
| Herpes simplex virus nucleic acid-based assay for central nervous system infections | March 21, 2014 |
| Cream for x-ray attenuation | May 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.