The FDA has officially excluded certain software from the definition of a medical device (Final Rule: 86 FR 20278). Eight regulations are being amended. The classifications include Clinical Chemistry and Clinical Toxicology Devices under Part 862, Immunology and Microbiology Devices under Part 866, General Hospital and Personal Use Devices under Part 880, Obstetrical and Gynecological Devices under Part 884, and Radiology Devices under Part 892. The table below is copied from the final rule.
| Classification Regulation (21 CFR) | Device type (existing product code[s]) |
|---|---|
| 862.2100 | Calculator/Data Processing Module for Clinical Use (JQP, NVV) |
| 862.1350 | Continuous Glucose Monitor Secondary Display (PJT, PKU) |
| 866.4750 | Automated Indirect Immunofluorescence Microscope and Software-Assisted System (PIV) |
| 880.6310 | Medical Device Data System (OUG) |
| 884.2730 | Home Uterine Activity Monitor (LQK, MOH) |
| 892.2010 | Medical Image Storage Device (LMB, NFF) |
| 892.2020 | Medical Image Communications Device (NFG, LMD) |
| 892.2050 | Picture Archiving and Communications System (QIH, OMJ, NWE, PGY, OEB, QKB, PZO, NFJ, LLZ) |
All software under these regulations will now be exempt from regulation as medical devices. Hardware devices under these regulations will continued to be regulated.
This change eliminates a grey area in the US regulatory landscape. In the past, some software products like Electronic Health Records or Radiology Image Storage Databases could have fallen into enforcement discretion as Medical Device Data Systems (MDDS) in product code OUG. Other products could have been considered non-regulated (“wellness”) products outside the definition of a medical device.
Now, most software products used to display, transfer and store data will be outside the definition of a medical device. As long as they do not perform an active hardware monitoring function (e.g. a bedside monitor), analyze data for autonomous diagnosis, or are used for bloodbank record keeping, software-only products and “communications protocol” products are now very unlikely to be regulated as medical devices by the FDA. Note that all hardware products in these classifications are still regulated.
Please contact AlvaMed if you have any questions about your software product classification or regulatory pathway.
