Medical device manufacturers developing novel devices without predicate alternatives are automatically assigned a Class III designation unless they pursue De Novo classification. MiCOM Labs provides A2LA-accredited testing services under ISO/IEC 17025 that support De Novo submissions with comprehensive test data required for Class I or Class II reclassification.
The De Novo pathway provides a risk-based classification process for novel medical devices that lack legally marketed predicates. The FDA evaluates whether general controls alone or general controls combined with special controls provide reasonable assurance of safety and effectiveness.
Manufacturers pursue De Novo classification under two circumstances:
You determine that no legally marketed predicate device exists for substantial equivalence comparison.
The FDA issues a not substantially equivalent decision following 510(k) review because no predicate device exists.
The FDA's review goal under MDUFA V targets 150 FDA review days from submission receipt to decision. This timeline excludes hold periods when the agency requests additional information.
| Requirement Category | Documentation Elements |
|---|---|
| Administrative Information | Device intended use, prescription designation, and cover sheet identifying De Novo request |
| Device Description | Technology overview, proposed conditions of use, accessories, and components |
| Classification Justification | Proposed class designation, rationale for general controls, or general controls with special controls |
| Safety and Effectiveness Data | Clinical data (if applicable), non-clinical bench testing, biocompatibility evaluation, software validation |
| Risk-Benefit Analysis | Comparison of probable benefits vs. risks when the device functions as intended |
The De Novo review follows a structured sequence with defined timelines for each phase.
FDA conducts technical screening via eSTAR, validating submission completeness against 21 CFR 860.230 acceptance criteria. Incomplete submissions trigger a deficiency notification; manufacturers have 180 calendar days to submit a replacement.
FDA review goal under MDUFA V from submission receipt to decision, excluding hold periods when the agency requests additional information.
When deficiencies are identified, an Additional Information letter is issued. Manufacturers have 180 calendar days to respond. No extensions apply — the FDA considers requests withdrawn if the deadline passes.
Source: Medical Device Academy FY 2026 User Fees; FDA MDUFA V Performance Goals
| Submission Type | Timeline | User Fee (FY 2026) | Device Category |
|---|---|---|---|
| 510(k) | 90 days (goal) | $26,067 | Devices with predicates |
| De Novo | 150 review days | $173,733 | Novel low-moderate risk devices |
| PMA | 180 days | $540,783 | High-risk Class III devices |
FDA acceptance of De Novo submissions requires test data from laboratories holding ISO/IEC 17025 accreditation. Test results must meet documentation and traceability standards recognized globally by regulatory authorities.
Medical electrical equipment requires testing in accordance with IEC 60601-1. Laboratory instruments require testing in accordance with IEC 61010. These standards evaluate:
Insulation integrity and protective earth connections
Leakage current limits under normal and fault conditions
Temperature rise on accessible surfaces
Mechanical stability and resistance to stress
Protection against fluid ingress
IEC 60601-1-2 establishes EMC testing requirements for medical electrical equipment. Testing validates that devices operate reliably in clinical environments without causing harmful interference.
| Test Type | Purpose | Standard |
|---|---|---|
| Radiated Emissions | Prevents interference with nearby medical equipment | IEC 60601-1-2, EN 55032, FCC Part 15 |
| Conducted Emissions | Eliminates power line interference in healthcare facilities | IEC 60601-1-2, EN 55032 |
| Harmonic Current | Protects power grid stability | IEC 61000-3-2 |
| Voltage Fluctuations | Maintains power quality for life-supporting equipment | IEC 61000-3-3 |
| Test Type | Application | Standard |
|---|---|---|
| Radiated Immunity | Ensures function during RF exposure from wireless equipment | IEC 61000-4-3, IEC 60601-1-2 |
| Conducted Immunity | Validates operation during power line disturbances | IEC 61000-4-6 |
| ESD Immunity | Prevents system failure from static discharge | IEC 61000-4-2 |
| Surge Immunity | Protects against transient-induced failures | IEC 61000-4-5 |
Connected medical devices must pass RF compliance testing under FCC Part 15, Part 18, or Part 27, depending on the wireless technology. These tests verify emissions limits and ensure devices do not cause harmful interference.
MiCOM Labs performs testing up to 220 GHz and provides certification for FCC, ISED, EU RED, UKCA, and Japan MIC requirements.
MiCOM Labs provides end-to-end De Novo support through accredited testing, real-time visibility, and certification workflow management tools.
ISO/IEC 17025 accredited lab (Certificate #2381.01) with results accepted by FDA, Health Canada, and EU regulators
Live test monitoring, automated updates, and early access to provisional results to reduce testing time
Centralized platform for tracking certifications, managing documentation, and receiving compliance alerts
Engaging with the FDA before formal submission prevents costly redesigns and regulatory delays. Two mechanisms facilitate early clarification of requirements.
Provides a formal FDA determination of device classification
Discussion with FDA on testing, documentation, and requirements
Medical device manufacturers targeting international markets require testing and certification across multiple jurisdictions. MiCOM Labs holds direct certification authority in five major markets through bilateral mutual recognition agreements.
| Market | Regulatory Body | MiCOM Labs Status |
|---|---|---|
|
🇺🇸
United States
|
FCC | Telecommunication Certification Body (TCB) |
|
🇨🇦
Canada
|
ISED | Foreign Certification Body (FCB) |
|
🇪🇺
European Union
|
CE | Notified Body under US-EU MRA |
|
🇬🇧
United Kingdom
|
UKCA | Approved Body under US-UK MRA |
|
🇯🇵
Japan
|
MIC | Registered Certification Body (RCB) |
MiCOM Labs follows a structured process that ensures accurate testing and the timely preparation of submissions.
Equipment specs reviewed, manuals evaluated, applicable standards identified
Test protocol developed, samples defined, timeline estimated
Electrical safety, EMC, RF, and environmental testing performed
ISO/IEC 17025-compliant reports issued with documented compliance results
Documentation compiled, risk analysis finalized, submission package prepared
Equipment specs reviewed, manuals evaluated, applicable standards identified
Test protocol developed, samples defined, timeline estimated
Electrical safety, EMC, RF, and environmental testing performed
ISO/IEC 17025-compliant reports issued with documented compliance results
Documentation compiled, risk analysis finalized, submission package prepared
MiCOM Labs supports De Novo medical device manufacturers across key regulated healthcare segments.
IVD systems, analyzers, lab automation
Focus: EMC, safety
Remote monitors, telehealth devices
Focus: RF, EMC, wireless, safety
Imaging accessories, diagnostic analyzers
Focus: EMC, environmental, safety
Devices qualify for De Novo when no legally marketed predicate exists, and the device presents low to moderate risk. The manufacturer must demonstrate that general controls or general controls with special controls provide reasonable assurance of safety and effectiveness.
Yes. Since the FDA final rule in October 2021, manufacturers can submit De Novo requests directly when they determine that no predicate device exists. This eliminates the need to obtain a not substantially equivalent determination first.
The FDA's review goal targets 150 FDA review days, excluding hold periods. Total time from testing initiation through final decision typically ranges from six to nine months, depending on device complexity and the completeness of initial documentation.
The device remains in Class III. Manufacturers must either submit a Premarket Approval (PMA) application or collect additional data to address the identified deficiencies and submit a new De Novo request.
MiCOM Labs provides comprehensive testing services for bench performance, electrical safety, EMC, and RF compliance. For clinical studies, we coordinate with qualified clinical research organizations while managing the overall compliance timeline.
Medical device manufacturers benefit from early engagement with accredited testing laboratories that understand FDA De Novo submission requirements. Comprehensive test data, proper device classification, and thorough documentation reduce review delays and increase classification success rates.
MiCOM Labs delivers A2LA-accredited testing services for medical device manufacturers preparing De Novo submissions. Our automated testing platforms and direct certification authority in major markets reduce time-to-market while ensuring regulatory acceptance.
Contact MiCOM Labs to discuss your device specifications, target classification, and testing requirements.
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