Which FDA pathway fits your device: 510(k), De Novo or PMA?
We guide medical device and IVD manufacturers through FDA clearance and approval, from choosing between 510(k), De Novo and PMA to submission. The pathway determines the evidence required and is settled before the first study, with Q-Sub and, where they fit, Breakthrough and TAP.
Overview
Which FDA pathway fits your device?
510(k), De Novo, PMA, Breakthrough and TAP · 21 CFR Parts 807, 814, 820, 860 · QMSR harmonized with ISO 13485:2016
Last updated: October 29, 2026
For most devices, US market access runs through 510(k), De Novo or PMA. Which one applies follows from classification, risk, and whether a predicate, a classification regulation or a PMA approval exists for the device type. Q-Sub meetings and FDA programs do not change the standard, but they change how you work with the FDA.
- Classification: the device class and product code decide whether a device is exempt from 510(k), needs a 510(k), or needs a PMA. A device that is not substantially equivalent to a device of a classified type falls into Class III under FD&C Act Sec. 513(f)(1) until it is classified through De Novo or a petition.
- 510(k): the route for devices that do not require a PMA and are not exempt, mostly Class II. It requires a predicate with the same intended use and comparable technological characteristics, shown in a comparison argument under FD&C Act Sec. 513(i). Under 21 CFR 807.92(a)(3), a predicate is a device marketed before May 28, 1976, reclassified from Class III to II or I, or found substantially equivalent through a 510(k); a PMA device is not one as such. According to the FDA, the decision is usually made within 90 days.
- De Novo: for devices of low to moderate risk whose device type has no predicate, no classification regulation and no PMA approval (FD&C Act Sec. 513(f)(2), 21 CFR Part 860 Subpart D). The FDA may decline the request if it finds a possible predicate or the risk is higher. A possible result is a new Class I or II; a device classified this way then serves as a predicate.
- PMA under 21 CFR Part 814: the route for Class III devices, with standalone evidence of safety and effectiveness. The Humanitarian Device Exemption (HDE, Subpart H) is a separate route for devices for conditions affecting no more than 8,000 individuals per year in the US, for diagnostics no more than 8,000 patients examined; it requires an HUD designation and does not demand the proof of effectiveness of a PMA.
- Programs: the Breakthrough Devices Program (FD&C Act Sec. 515B) is open to devices that treat or diagnose life-threatening or irreversibly debilitating conditions more effectively; the Safer Technologies Program (STeP) to devices for less serious conditions with a substantial safety improvement. Both apply to 510(k), De Novo and PMA. After a designation or inclusion in STeP, a device can enter the limited TAP pilot.
- Formal entry barrier: the eSTAR template is mandatory for the 510(k) since October 2023 and for De Novo since October 2025. The CDRH Portal does not accept an incomplete eSTAR, and there is no refuse-to-accept check for it; instead the FDA aims to complete a technical screening within 15 days of whether the entries match the device and the attachments fit. A deficiency puts the submission on hold for up to 180 days. For De Novo, the acceptance review under 21 CFR 860.230 is largely automated within the eSTAR.
Services
How we support you
Classification & Pathway Selection
Determination of the device class and product code under 21 CFR Parts 862 to 892, a check for exemption from 510(k), and a comparison of the 510(k), De Novo and PMA pathways against product, evidence and timeline. The result is a reasoned pathway recommendation, with a predicate analysis and a documented comparison table for a 510(k).
Breakthrough Devices Program, STeP and TAP
Assessment of whether a device meets the criteria of the Breakthrough Devices Program or the Safer Technologies Program, preparation of the designation request as a Q-Submission and, once designated, the request for enrollment in TAP. Enrollment requires that no pre-submission and no sprint discussion has been submitted for the device since the designation.
US Market Access & QMSR
Establishment registration and device listing under 21 CFR Part 807, designation of the US Agent under 21 CFR 807.40, and a gap analysis of the QM system against the QMSR (21 CFR Part 820).
How we work together
What it comes down to
The most expensive decision in US market access is made before a single study is planned: the choice of pathway. Classification, risk, and whether a predicate, a classification regulation or a PMA approval exists for the device type decide between 510(k), De Novo and PMA. Each pathway requires different evidence, which is why the pathway choice comes before the testing strategy and the testing budget.
On top of that come instruments that do not change the standard but do change how you work with the FDA: a pre-submission meeting (Q-Sub) clarifies the FDA's evidence expectations before testing budget is committed. The Breakthrough Devices Program gives devices for life-threatening or irreversibly debilitating conditions prioritized review, and TAP accompanies a limited group of these devices with FDA advisors.
In a 510(k) procedure, the choice of the predicate device determines everything downstream: the formulation of the intended use, the selection of the performance tests, and the structure of the substantial equivalence demonstration under FD&C Act Sec. 513(i). Before that comes a formal hurdle: the mandatory eSTAR template is accepted by the portal only when complete, and the FDA's technical screening puts submissions with inconsistent entries or missing attachments on hold before a reviewer reads the substance.
For European manufacturers, a second lever comes into play: the technical documentation under EU 2017/745 supplies a large share of the raw data for the eSTAR dossier, but only the mapping onto the FDA comparison logic turns it into a submission that survives the 90-day review without an additional information loop.
Our approach
Our approach
Step
Result
Classification & Pathway Selection
Documented classification of device class and product code, in doubtful cases backed by a 513(g) response from the FDA, a documented decision for 510(k), De Novo or PMA, and a checked fit for the Breakthrough Devices Program or STeP.
Predicate Analysis
Selected predicate device with a comparison table for intended use and technological characteristics.
Pre-Submission (Q-Sub)
Documented FDA feedback on testing strategy and open questions, before testing costs are incurred.
Evidence & Testing
Performance and biocompatibility data under FDA-recognized consensus standards, fully referenced in the dossier.
eSTAR Submission
Complete eSTAR dossier, passed technical screening, procedure in substantive review.
Review & Clearance
Answered additional information requests, the FDA decision (510(k) clearance, De Novo grant order or PMA approval), followed by registration and listing under 21 CFR Part 807.
Common pitfalls
Where projects commonly fail
The pathway is chosen by habit instead of by device.
A manufacturer that files a 510(k) without a viable predicate ends in an NSE determination, after which De Novo remains open as a follow-on route (21 CFR 860.200(b)(1)); one that requests De Novo although a predicate, a classification regulation or a PMA approval exists for the device type risks a hold or a decline (FD&C Act Sec. 513(f)(2)(A)(iv) for the predicate, 21 CFR 860.260(c)(5) and (6) for a PMA approval and a classification regulation). Both can be clarified before the first study.
The predicate device is chosen by technological similarity instead of intended use.
If the intended use diverges, the procedure ends in an NSE determination (Not Substantially Equivalent), and the entire testing strategy was anchored to the wrong reference.
The technical screening is underestimated as a formality.
The portal accepts only a complete eSTAR, and the FDA additionally checks that the entries are accurate (for example, answers in drop-down fields that hide follow-up questions) and that each question has a relevant attachment. A submission that fails sits on hold until a replacement eSTAR arrives, for up to 180 days, before a reviewer reads the substance.
In borderline cases, the submission is filed without a pre-submission.
Particularly with novel technology or an expanded intended use, only the Q-Sub meeting clarifies what evidence the FDA expects. Without that clarification, an additional information request often follows, stretching the procedure from the 90-day target to 6 to 12 months.
The programs are assessed too late.
A designation request is possible at any time before the submission (FD&C Act Sec. 515B(c)), but under the FDA's enrollment criteria TAP is open only if no pre-submission, including no sprint discussion, has been submitted for the device since the designation and the device is early in development, for example before the pivotal study starts. A manufacturer that files a pre-sub first after designation rules out TAP.
The EU documentation is adopted unchanged.
The clinical evaluation under MDR logic (EU 2017/745) does not replace the substantial equivalence argument under FD&C Act Sec. 513(i). The FDA expects the direct comparison against the predicate, not a standalone benefit-risk evaluation in the European format.
The QMSR transition is ignored.
21 CFR Part 820 now applies in the QMSR version aligned with ISO 13485:2016. A manufacturer that organizes inspection readiness and the availability of the US Agent only after clearance risks findings at the first FDA inspection.
Regulatory Affairs
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- Federal Food, Drug, and Cosmetic Act, Sec. 513 (classification, substantial equivalence, De Novo) and Sec. 515B (Breakthrough Devices, 21 U.S.C. 360e-3)
- 21 CFR Part 807 (establishment registration, device listing, 510(k) premarket notification, US Agent)
- 21 CFR Part 814 (premarket approval, Subpart H Humanitarian Device Exemption), Part 820 (QMSR), Part 860 (classification procedures, Subpart D De Novo)
- FDA Guidance: Electronic Submission Template for Medical Device 510(k) Submissions (October 2, 2023) and De Novo Requests (August 23, 2024); Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (May 29, 2025)
- FDA Guidance: Breakthrough Devices Program (September 15, 2023); Safer Technologies Program for Medical Devices
- FDA: Total Product Life Cycle Advisory Program (TAP), pages Enrollment & Expansion (as of July 1, 2026) and overview (as of October 7, 2026); Federal Register 87 FR 61605 (October 12, 2022)
- FDA: eSTAR Program (mandatory for 510(k) and De Novo)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- FD&C Act Sec. 513(f)(1) (Class III for new devices until classified)
- FD&C Act Sec. 513(i) (Substantial Equivalence)
- FD&C Act Sec. 513(f)(2) (De Novo Classification)
- FD&C Act Sec. 515B (Breakthrough Devices)
- 21 CFR Part 807 Subpart E (510(k) Premarket Notification)
- 21 CFR 807.40 (US Agent for foreign manufacturers)
- 21 CFR Part 814 (Premarket Approval, PMA)
- 21 CFR Part 814 Subpart H (Humanitarian Device Exemption, HDE)
- 21 CFR Part 860 (Medical Device Classification Procedures)
- 21 CFR Part 860 Subpart D (De Novo Classification)
- 21 CFR Part 820 (Quality Management System Regulation, QMSR)
- 21 CFR Parts 862–892 (classification regulations by product area)
- FDA Guidance: Breakthrough Devices Program (September 15, 2023)
- FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (May 29, 2025)
- ISO 13485:2016 (QM system)
- EU 2017/745 (MDR)
Related topics
MDR Conformity →
Synergies between EU market access under EU 2017/745 and US market entry
Clinical Compliance →
Clinical FDA requirements, particularly for PMA procedures
International Market Access →
The US market as one building block of a multi-market strategy
Health Authority Interaction →
Agency communication from Q-Sub meetings through to inspection
Qualification & Classification →
Qualification as medical device, IVD or medicinal product and classification under Annex VIII of the MDR and IVDR
510(k) Premarket Notification →
The 510(k) itself: predicate, substantial equivalence, tests, eSTAR and review
De Novo Classification →
The De Novo request itself: eligibility, special controls and building the request
Premarket Approval (PMA) →
The PMA itself: clinical evidence, modular submission, filing, panel and conditions
Q-Submission Program →
Q-Sub types, questions and meeting preparation before the submission
Breakthrough Devices Program & TAP →
The programs themselves: eligibility, designation request, sprints, DDP and TAP enrollment
FDA Establishment Registration, Listing & US Agent →
After clearance or approval: registration, device listing, UDI in GUDID and the US agent
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