FDA approval requirements for devices with software are changing
The U.S. Federal Register announced in April that the Food and Drug Administration (FDA) is changing some specific product definitions. The Agency is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking this action so that its regulations conform to the medical software provisions in the Cures Act. The listing below shows the affected product types for which the FDA changes are relevant. The changes to the “identification” description of these regulations do not affect the classification of the products (i.e., the product types remain Class I, Class II, etc.), but their functions are partially changed by definition.
- 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)
FDA is amending the “identification” description in eight classification regulations, so that they no longer include software functions that are excluded from the device definition by section 520(o)(1) of the FD&C Act and thus are not subject to FDA’s device statutory authority.
The FD&C Act describes software functions, not hardware functions, that are excluded from the definition of a device. Therefore, device hardware that is specifically intended to transfer, store, convert formats, and display medical device data and results (such as electrical hardware, magnetic and optical discs, physical communications medium, etc.) remains a device.