Table 3 Common standards for SaMD manufacturer adherence in the US35
Standard | Description |
|---|---|
21 CFR Part 11 | Electronic records; electronic signatures |
21 CFR Part 50 | Protection of human subjects |
21 CFR Part 54 | Financial disclosure by clinical investigators |
21 CFR Part 56 | Institutional review boards |
21 CFR Part 803 | Medical device reporting |
21 CFR Part 806 | Medical devices; reports of corrections and removals |
21 CFR Part 807 | Establishment registration and device listing for manufacturers |
21 CFR Part 812 | Investigational device exemptions |
21 CFR Part 820 | Quality system regulation |
21 CFR Part 830 | Unique device identification |
ISO 13485 | Medical devices—QMS—Requirements for regulatory purposes |
IEC 62304 | Medical device software—Software life cycle processes |
ISO 14971 | Medical devices – Application of risk management to medical devices |
IEC 62366 | Application of usability engineering to medical devices |
ISO 14155 | Clinical investigation of medical devices for human subjects—GCP |
AAMI SW96 | Standard for medical device security—security risk management for device manufacturers |
ISO 15223 | Symbols to be used with information to be supplied by the manufacturer |
ISO 20417 | Medical devices—information to be supplied by the manufacturer |
