SaMD Class II · De Novo Pathway

Regulatory Affairs

FDA De Novo submission roadmap — 18-month timeline, standards compliance matrix, predicate device analysis, clinical evidence tracker

De Novo
Pathway
Class II
Device Class
II/Non-Serious
SaMD Category
2/8
Standards Done
4
Standards Active
Q2 2027
Target Auth.
18-Month Submission Timeline
M1
M2
M3
M4
M5
M6
M7
M8
M9
M10
M11
M12
M13
M14
M15
M16
M17
M18
Pre-Sub Meeting Request
✓ Pre-Submission
Pre-Sub Meeting with FDA
✓ Pre-Submission
Clinical Study — Pilot
Preparation
Risk Management (ISO 14971)
Preparation
Software Lifecycle (62304)
Preparation
Usability Study (62366)
Preparation
De Novo Submission Draft
Submission
De Novo Filed with FDA
Submission
FDA Acceptance Review
FDA Review
Interactive Review
FDA Review
De Novo Authorization
Authorization
Post-Market Surveillance
Post-Market
Pre-Submission
Preparation
Submission
FDA Review
Authorization
Post-Market
Standards Compliance Matrix
StandardTitleClassificationProgressStatus
IEC 62304:2006+AMD1:2015Software LifecycleClass B
62%
active
IEC 62366-1:2015Usability EngineeringRequired
35%
active
ISO 14971:2019Risk ManagementRequired
55%
active
IEC 60601-1:2005+AMD2Electrical SafetyClass I
100%
complete
IEC 60601-1-2:2014EMCRequired
0%
pending
FDA SaMD Guidance 2019SaMD Clinical EvidenceN/A
48%
active
HIPAA Security RulePHI ProtectionRequired
100%
complete
FDA MDR 21 CFR 803Mandatory ReportingClass II
5%
pending
Clinical Evidence Requirements
✓
Analytical study — CFAR algorithm validation
2,400 radar frames, 100 scripted fall events; sens 94%, spec 94%
complete
✓
Benchtop study — Range & angle accuracy
IWR6843AOP at 1 Hz, 4.5 m range, ±15° azimuth — PASS
complete
●
Clinical pilot — MOH 36-unit deployment
ODAT-funded; IRB pending; 90-day study, 12 residents
active
Comparative study vs. EarlySense
Parallel deployment in 6 rooms, 30 days; planned post-pilot
pending
Post-market study — real-world fall events
n=200 fall events across ≥3 facilities; 12-month collection
pending
Predicate Device Comparison
Philips IntelliVue GuardianK192564 · 510(k)
▼
EarlySense LiveK162733 · 510(k)
▼
Alarm.com ADC-V725K202146 · 510(k)
▼