FDA / EU / Regulatory Updates
FDA excludes 8 software functions from the definition of a device
FDA is amending the “identification” description in eight classification regulations, so that they no longer include software functions (listed below) 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.
| Classification Regulation (21 CFR) |
Device Type (existing product code(s)) |
Software Functions excluded from FDA Oversight |
| 862.2100 |
Calculator/Data Processing Module for Clinical Use (JQP, NVV) |
“storing and retrieving data” |
| 862.1350 |
Continuous Glucose Monitor Secondary Display (PJT, PKU) |
“functions to receive and display medical device data (i.e., real-time glucose values and glucose trend information)” |
| 866.4750 |
Automated Indirect Immunofluorescence Microscope and Software-Assisted System (PIV) |
“fluorescent signal acquisition and processing software, data storage and transferring mechanisms” |
| 880.6310 |
Medical Device Data System (OUG) |
“”the electronic transfer of medical device data; the electronic storage of medical device data; the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or the electronic display of medical device data” |
| 884.2730 |
Home Uterine Activity Monitor (LQK, MOH) |
“functions intended to transmit, receive, and display data” |
| 892.2010 |
Medical Image Storage Device (LMB, NFF) |
“storage and retrieval functions” |
| 892.2020 |
Medical Image Communications Device (NFG, LMD) |
“electronic transfer of medical image software functions” |
| 892.2050 |
Picture Archiving and Communications System (QIH, OMJ, NWE, PGY, OEB, QKB, PZO, NFJ, LLZ) |
“storage and display of medical images” |
The FDA did not exclude device hardware that is specifically intended to transfer, store and display data, such as electrical hardware, magnetic and optical discs and physical communications media, and thus, will keep overseeing it.
EU Medical Device Coordinating Group (MDCG) publishes Guidance on standardisation for medical devices
The development of harmonized European standards is a major component of the new medical device (MDR) and IVD regulations, as products developed in conformity with harmonized standards are presumed to be in conformity with the corresponding legal requirements documented in the MDR and IVDR. Voluntary use of the standards is emphasized in the document.
The following standards are listed in the Guidance (among others related to Sterilization, Cardiovascular implants, Neurosurgical implants, Prosthetics, Biological evaluation of medical devices, Surgical clothing and drapes etc.):
- EN 62304:2006+A1:2015 Medical device software – Software life-cycle processes
- EN ISO 14971:2019 Medical devices – Application of risk management to medical devices
- EN ISO 13485:2016+AC:2018 Medical devices – Quality management systems – Requirements for regulatory purposes
- EN ISO 14971:2019 Medical devices – Application of risk management to medical devices
- EN 62366-1:2015+AC:2015+AC:2016+A1:2020 Medical devices – Application of usability engineering to medical devices
- EN 80001-1:2011 Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management
- EN 82304-1:2017 Health Software – Part 1: General requirements for product safety
