Approval requirements for devices with software are changing
It was announced in the US Federal Register in April that the Food and Drug Administration FDA) is changing certain product definitions to comply with changes to current legislation in the country. The 21st Century Cures Act changed the definition of a device and excluded certain software features from regulatory consideration. Listed below are the affected product types for which the FDA changes are relevant. The FDA changes to the „Identifications“description of these regulations do not affect the classification of the devices (i.e., the device types remain Class I, Class II, etc.), but their functions are partially changed by definition.
Product types
- 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 description of ‘identification’ of the eight classification regulations so that they no longer include software functions that are excluded from the device definition and thus not subject to FDA's statutory authority for devices.
The FD&C Act describes software functions, not hardware functions, that are excluded from the definition of a device. Therefore, device hardware specifically intended for the transmission, storage, format conversion, and display of medical device data and results (such as electrical hardware, magnetic and optical discs, physical communication media, etc.) remains a device.
For more details, see the publication in the Federal Register or contact the FDA.
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