Choosing the right regulatory pathway is critical for your medical device's time-to-market and development costs. This tool helps you determine whether 510(k), De Novo, or PMA is the appropriate pathway based on your device's characteristics and risk profile.
510(k)
3-6 mo
510(k)+
4-12 mo
De Novo
6-12 mo
PMA
1-3 yr
Determine the appropriate FDA submission pathway for your device
High-Level FDA Regulatory Pathway Overview
Class I
Low Risk
Usually Exempt
Class II
Moderate Risk
510(k) / De Novo
Class III
High Risk
PMA Required
Class I devices are low-risk and subject to General Controls only. Most are exempt from 510(k) premarket notification.
510(k) Exemption
~75% of Class I devices exempt from premarket notification (check 21 CFR 862-892)
QSR Exemption
Many Class I also exempt from full QSR (21 CFR 820), but must follow general controls
Answer questions to find your specific pathway
Breakthrough
Priority review for life-threatening conditions
EUA
Emergency Use Authorization only
Custom Device
≤5 units/year, specific patient
PDP
Product Development Protocol
Safety & Perf. 510(k)
FDA-published criteria pathway
Traditional 510(k)
90-180 days (FDA goal: 90 days)
Clinical: sometimesSpecial 510(k)
30 days (FDA goal)
Clinical: neverAbbreviated 510(k)
60-90 days
Clinical: neverSafety & Performance Based 510(k)
60-90 days
Clinical: neverDe Novo
150 days (FDA goal)
Clinical: sometimesPMA
180 days FDA review + clinical trial time (often 1-5 years total)
Clinical: alwaysPMA Supplement
30-180 days depending on type
Clinical: sometimesExempt
No FDA review required
Clinical: neverPDP
Similar to PMA (1-5 years)
Clinical: alwaysHDE
75 days (FDA goal)
EUA
Variable (days to weeks during emergency)
Breakthrough Designation
Uses underlying pathway (510(k), De Novo, PMA) with priority review
Custom Device
No FDA review required
IDE (Significant Risk)
30 days FDA review + study duration
21 CFR 812
IDE (Nonsignificant Risk)
IRB approval + study duration
21 CFR 812.2(b)
IDE Exempt
IRB approval + study duration
21 CFR 812.2(c)
FDA's Small Business Determination (SBD) Program offers significantly reduced user fees for businesses with ≤$100M gross receipts.
Important Disclaimer
This tool provides preliminary guidance only. FDA has final authority on pathway requirements. Pre-Submission (Q-Sub) meetings with FDA are recommended for novel or complex devices. User fees shown are FY2026 MDUFA rates and subject to annual adjustment.
| Factor | 510(k) | De Novo | PMA |
|---|---|---|---|
| Predicate Required | Yes | No | No |
| Typical Device Class | II (some III) | I or II | III |
| Clinical Data | Sometimes | Sometimes | Usually |
| FDA User Fee (FY2026) | $26,067 | $173,782 | $579,272 |
| Review Timeline | ~90 days | ~150 days | ~180 days |
| Standard of Review | Substantial Equivalence | General/Special Controls | Safety & Effectiveness |
For 510(k), you must show your device has the same intended use as the predicate and either: (1) same technological characteristics, or (2) different characteristics that don't raise new safety/effectiveness questions.
A legally marketed device that your device is compared to. Can be a pre-1976 device, a 510(k)-cleared device, a De Novo device, or a reclassified device.
A meeting or written feedback request with FDA to discuss regulatory pathway, testing requirements, or clinical study design before submitting your application.
Required for clinical studies of significant risk devices. Allows investigational use while gathering data for regulatory submission.
IDE regulations govern how clinical studies of investigational devices may be conducted in the US. The type of IDE required depends on the device's risk determination.
| Study Type | FDA Approval | IRB Approval | Key Requirements |
|---|---|---|---|
| Significant Risk (SR) | Required | Required | Full IDE submission, 30-day FDA review, ongoing reporting, AE reporting within 10 days |
| Nonsignificant Risk (NSR) | Not Required | Required | Abbreviated requirements per 812.2(b), sponsor makes NSR determination with IRB concurrence |
| Exempt (812.2(c)) | Not Required | Required | Legally marketed devices, certain IVDs, consumer preference studies |
A device is Significant Risk if it:
Use when:
Use when:
Use when:
FDA guidance on choosing submission type
Complete device marketing overview
Get FDA feedback before submission
When and what clinical data is needed
Using RWD in regulatory decisions
Expedited development and review