Medical Device Risk Classes: FDA
Medical device regulatory classification rules, risk levels, and required regulatory pathways. Covers four frameworks: FDA 21 CFR Part 860 (Class I / I_non-exempt / II / II_De_Novo / III / III_HDE / III_PDP with 510(k)/De_Novo/PMA/HDE pathways), EU MDR 2017/745 (Class I variants: non-sterile_non-measuring, sterile, measuring, reusable_surgical; Class IIa, IIb, III; Notified Body requirements and PSUR/PMCF obligations), ISO 14971:2019 risk management severity scale (Severity_1_Negligible through Severity_5_Catastrophic with probability/risk matrix guidance), and IEC 62304:2006+AMD1:2015 medical device software safety classes (A: no harm, B: non-serious injury, C: death or serious injury) with SDLC documentation requirements. Each record includes device examples, regulatory pathway, premarket requirements, postmarket obligations, key classification criteria, and cross-reference to applicable IEC 62304 software safety class.
| regulatory framework | device class | class description | device examples | key criteria | notes | postmarket requirement | premarket requirement | regulatory pathway | risk level | software relevance |
|---|---|---|---|---|---|---|---|---|---|---|
| FDA | Class_I | General Controls | Bandages, tongue depressors, elastic bandages, non-powered stethoscopes, elastic compression stockings, non-sterile non-measuring syringes | General controls alone sufficient for safety; minimal potential for harm; most are exempt from 510k; ~47% of all devices | Class I devices must still comply with 21 CFR Part 820 QSR and labeling requirements | MDR_reporting | 510k_if_not_exempt | Exempt_or_510k | Low | IEC_62304_Class_A (no injury possible) |
| FDA | Class_II | Special Controls + 510k | Infusion pumps, powered wheelchairs (advanced), ECG machines, hearing aids, x-ray systems diagnostic, contact lenses, pregnancy tests, surgical drapes, bone graft substitutes | Requires general controls plus special controls (performance standards; postmarket surveillance; patient registries; special labeling; premarket data; guidelines); substantial equivalence to predicate required | ~43% of all devices; special controls may include mandatory performance testing or clinical data; FDA issues special controls guidance documents | MDR + postmarket_surveillance | Premarket_Notification_510k + Special_Controls | 510k | Moderate | IEC_62304_Class_B (non-serious injury possible) |
| FDA | Class_III | General + Special Controls + PMA | Heart valves, pacemakers, cochlear implants, ventricular assist devices, deep brain stimulators, coronary artery stents, total artificial hearts, implantable cardioverter-defibrillators | Life-sustaining or life-supporting implantable devices; high risk of illness/injury; requires valid scientific evidence of safety and effectiveness (usually clinical trials); ~10% of all devices | PMA requires full clinical evidence; review 180 days (standard) or 320 days (panel track); annual PMA reports required; manufacturing changes require PMA supplements; failure mode: mandatory recalls | Mandatory_post-approval_studies + MDR | Premarket_Approval_PMA | PMA | Highest | IEC_62304_Class_C (death or serious injury possible) |
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