How do you bring your medical device to the US market via 510(k), De Novo or PMA?
We guide manufacturers of medical devices and IVDs through the FDA market access pathways 510(k), De Novo and PMA, from classification and predicate strategy through pre-submission meetings to eSTAR submission and clearance. A 510(k) is rarely decided during the 90-day review, but before it: a weak predicate choice or a formal error stops the submission as early as the 15-day Refuse-to-Accept check.
- MedTech
- IVD
Overview
How do you establish substantial equivalence in a 510(k) submission?
510(k), De Novo and PMA · 21 CFR Parts 807, 814, 820, 860 · QMSR harmonized with ISO 13485:2016
Last updated: 2026-06-12
The FDA reviews formal completeness with extreme rigor: formal errors or a weak equivalence argument lead to a Refuse-to-Accept before a reviewer reads the substance. The four points where US market access most often gets stuck:
- Pathway selection: the 510(k) premarket notification under 21 CFR Part 807 Subpart E is the standard route for most Class II devices, the PMA under 21 CFR Part 814 applies to Class III, and De Novo under FD&C Act Sec. 513(f)(2) applies to novel devices without a predicate. Borderline cases are decided by the argument made to the agency.
- Substantial equivalence under FD&C Act Sec. 513(i): the same intended use and comparable technological characteristics relative to a legally marketed predicate device, evidenced in a structured comparison argument. A poorly chosen predicate breaks the entire demonstration.
- Formal entry barrier: the Refuse-to-Accept check verifies the completeness of the submission within 15 days. Since October 2023, the submission of 510(k)s via the eSTAR template has been mandatory.
- Operational obligations: establishment registration and device listing under 21 CFR Part 807, a US Agent for foreign manufacturers under 21 CFR 807.40, and a QM system under 21 CFR Part 820 (QMSR, harmonized with ISO 13485:2016).
Services
How we support you
Classification & Predicate Strategy
Determination of the device class and product code under 21 CFR Parts 862 to 892, predicate analysis with a documented comparison table, and a reasoned pathway recommendation: 510(k), De Novo or PMA.
Pre-Submission Meetings (Q-Sub)
Preparation of the Q-Sub briefing package, formulation of the questions for the FDA, and support during the meeting, including a documented assessment of the FDA feedback for the testing strategy.
Learn more →510(k) eSTAR Submission
Build-out of the complete 510(k) dossier in the mandatory eSTAR template: substantial equivalence demonstration, integration of performance testing and biocompatibility data, and an RTA pre-check before submission.
De Novo & PMA
De Novo request with a proposal for special controls under FD&C Act Sec. 513(f)(2), as well as the build-out and management of PMA submissions under 21 CFR Part 814 for high-risk devices.
Learn more →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).
Synergy with MDR Documentation
Mapping of the existing technical documentation under EU 2017/745 onto the eSTAR structure, so that performance and evidence data are not generated twice.
Learn more →How we work together
What it comes down to
US market access rarely fails for lack of data, but for the wrong sequence. 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). Anyone who starts testing before the predicate is settled generates data against the wrong benchmark. And ahead of any substantive review stands the formal hurdle: the mandatory eSTAR template and the Refuse-to-Accept check screen out incomplete submissions within 15 days, without a reviewer having read the substance.
That is why the work begins before the submission: classification and pathway selection under 21 CFR Part 860, then anchoring the predicate, then, in borderline cases, a pre-submission meeting (Q-Sub) that clarifies the FDA's evidence expectations before testing budget is committed. 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
Confirmed device class and product code, documented decision for 510(k), De Novo or PMA.
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 per FDA-recognized consensus standards, fully referenced in the dossier.
eSTAR Submission
Complete eSTAR dossier, passed Refuse-to-Accept check, procedure in substantive review.
Review & Clearance
Answered additional information requests, clearance or approval, followed by registration and listing under 21 CFR Part 807.
Common pitfalls
Where projects commonly fail
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 Refuse-to-Accept check is underestimated as a formality.
Missing mandatory eSTAR information or administrative gaps stop the submission within 15 days, before a reviewer reads the substance. Every RTA loop sets time-to-market back by weeks.
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 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. Anyone who organizes inspection readiness and the availability of the US Agent only after clearance risks findings at the first FDA inspection.
FAQ
Frequently asked questions
Sources
- Federal Food, Drug, and Cosmetic Act, Sec. 513 (classification, substantial equivalence, De Novo)
- 21 CFR Part 807 (establishment registration, device listing, 510(k) premarket notification, US Agent)
- 21 CFR Part 814 (premarket approval), Part 820 (QMSR), Part 860 (classification procedures)
- FDA Guidance: Refuse to Accept Policy for 510(k)s; FDA Q-Submission Program Guidance
- /Users/MWeber/Documents/entourage-website-writer/output/expertise-pages/regulatory-compliance/fda-zulassung-medizinprodukte/fda-zulassung-medizinprodukte.md (writer briefing)
- https://theentourage.de/regulatory-compliance/fda-zulassung-medizinprodukte/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- FD&C Act Sec. 513(i) (Substantial Equivalence)
- FD&C Act Sec. 513(f)(2) (De Novo Classification)
- 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 860 (Medical Device Classification Procedures)
- 21 CFR Part 820 (Quality Management System Regulation, QMSR)
- 21 CFR Parts 862–892 (classification regulations by product area)
- ISO 13485:2016 (QM system)
- EU 2017/745 (MDR)
Related topics
MDR Consulting →
Leverage 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
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