The US Food and Drug Administration (FDA) has recently published a new policy in the Federal Register, to modify identifications of medical software in classification regulations. There are some software functions that would no longer be regulated by the FDA.

This has come into implementation to ensure the regulatory agency corresponds to what is currently delineated in the Federal Food, Drug, and Cosmetic Act (FD&C Act), whereby selected software functions have been removed from the definition of a medical device.

The FD&C Act was amended when the 21st Century Cures Act made some changes to the definition of these medical software that posed minimal risk to patients and, absent a specific safety concern, hence did not require FDA regulatory oversight. It was done in an act to streamline market access for manufacturers of pharmaceutical products and medical devices, at times by curtailing the agency’s authority. The five categories of the software listed were:

  1.  Software for administrative support of healthcare facilities
  2.  “Healthy lifestyle” software that provides no diagnostic, prevention, or treatment function
  3.  Electronic patient records
  4.  Software for transferring, storing, or displaying medical device or clinical laboratory test data but that does not support interpretation or analyze clinical data
  5.  Software to acquire, process, or analyze medical images from an IVD or signal acquisition system

To sum up the above, FDA is adjusting the “identification” description in eight classification regulations, so that they are excluded from the medical device definition by the original clauses in the FD&C Act (section 520(o)(1)) and thus are not subject to FDA's device statutory authority. Please refer to Table 1 below.

Specific details on the changes of regulation are available on Federal Register. The final rule is effective on the same date of publication in the Federal Register.

Classification regulation (21 CFR)

Device type (existing product code(s))


Calculator/Data Processing Module for Clinical Use (JQP, NVV).


Continuous Glucose Monitor Secondary Display (PJT, PKU).


Automated Indirect Immunofluorescence Microscope and Software-Assisted System (PIV).


Medical Device Data System (OUG).


Home Uterine Activity Monitor (LQK, MOH).


Medical Image Storage Device (LMB, NFF).


Medical Image Communications Device (NFG, LMD).


Picture Archiving and Communications System (QIH, OMJ, NWE, PGY, OEB, QKB, PZO, NFJ, LLZ).

Table 1: Classification Regulations Amendments [3]




  1. 21st Century Cures Act
  2. Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
  3. Medical Devices; Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures Act