510(k) Submission

This topic is part of the SG Systems Global medical device regulatory submissions, design controls & QMS integration glossary.

Updated December 2025 • QMS, ISO 13485, ISO 14971, QMSR, 21 CFR 820, 21 CFR 11, 21 CFR 807, DMR, DHF, DHR, Change Control, QRM, TMV, Process Validation, UDI

510(k) submission (Premarket Notification) is the regulatory package a medical device manufacturer sends to FDA to demonstrate that a device is at least as safe and effective as a legally marketed “predicate” device. It’s not a formality, and it’s not just paperwork. A 510(k) is the structured story that links design intent, risk management, bench/animal/clinical evidence, labeling and manufacturing controls back to a specific regulatory claim: this device is substantially equivalent to that one, for these indications, under these conditions.

For a lot of organisations, 510(k) is where reality hits the QMS. Weak design controls, patchy risk files, shaky test methods and undocumented changes all surface when you try to stitch them into a coherent submission. A strong 510(k) process doesn’t start when RA opens the template; it starts the day you define user needs and risk controls and decide what evidence will prove you’re not guessing.

“If you’re building the 510(k) from scratch in the last three months before launch, you don’t have a submission problem — you have a design-control problem.”

1) What Is a 510(k) Submission?

A 510(k) submission is FDA’s mechanism for premarket review of most moderate‑risk devices. You notify FDA before marketing and provide enough information for them to decide whether your device is substantially equivalent to a predicate device that is already legally on the US market.

At a high level, every 510(k) has to answer five questions clearly:

• What is the device and what is it used for (indications for use, target population, environment)?
• What is the predicate (or predicates) and why is it appropriate?
• How is your device the same as the predicate (intended use, technology) and how is it different?
• What risks do those differences create and how have you controlled and tested them?
• What evidence shows the device performs safely and effectively under intended conditions of use?

Everything else — administrative sections, checklists, summaries — exists to structure those answers and make FDA’s review efficient and defensible.

2) Where 510(k) Fits in Device Classification & Strategy

The need for a 510(k) comes from classification and regulatory strategy, not from a marketing deadline. In broad strokes:

• Class I: many are exempt from premarket notification but still require a compliant QMS, labeling, and other controls.
• Class II: typically require 510(k) clearance unless specifically exempted; many are subject to device‑specific special controls.
• Class III: usually require PMA; a minority have 510(k) pathways or De Novo routes depending on risk and history.

Getting classification wrong is expensive. Over‑classify and you burn time and budget; under‑classify and you face refusal to accept, non‑substantive review, or worse. That’s why regulatory strategy, including 510(k) pathway selection, should be established early and re‑validated as the design evolves and comparable devices emerge.

3) When a 510(k) Is Required — and When a New One Is Triggered

You typically need a 510(k) before you:

• Market a new device for the first time in the US under your own name and registration.
• Introduce a device type or indication that isn’t covered by your existing clearances.
• Make significant changes to an already‑cleared device that could affect safety or effectiveness.

Change‑trigger logic is where a lot of manufacturers get nervous. Every modification — design, materials, software, labeling, manufacturing process — should be evaluated through defined change control and documented 510(k) decision trees. Some changes clearly require a new 510(k); some clearly do not. The trouble lies in the grey zone, especially when risk controls, software behavior or indications creep over time. “We thought it was minor” is not persuasive if you can’t show a structured assessment.

4) Core Components of a 510(k) File

Templates vary (and FDA’s eSTAR format makes structure more explicit), but most 510(k)s cover at least:

• Administrative information: submitter details, device names, classification, product codes, registration/listing details.
• Indications for use: the precise statement of what the device is for, in whom, and in what setting.
• Device description: materials, design, key subsystems (mechanical, electrical, software), accessories.
• Substantial equivalence discussion: comparison tables vs predicate(s) on indications, technology, performance and features.
• Risk management summary: linkage to your risk file per ISO 14971; identification of hazards and mitigations, especially for differences vs predicate.
• Performance testing: bench testing, biocompatibility, electrical safety/EMC, software verification/validation, mechanical tests, shelf‑life, packaging validation; animal or clinical data where necessary.
• Labeling: instructions for use (IFU), labels, contraindications, warnings, promotional claims and how they align to indications and the evidence.
• Standards and guidance mapping: which consensus standards and FDA guidance documents you followed and where that evidence sits.

If you can’t easily assemble those elements from your DHF, risk files and validation reports, that isn’t “a submission issue”; it’s the QMS telling you that design control is fragmented or incomplete.

5) Substantial Equivalence and Predicate Selection

Substantial equivalence (SE) is the core of 510(k). You must show that your device has the same intended use as the predicate and either the same technological characteristics or that any differences don’t raise new questions of safety or effectiveness and are acceptable based on performance data.

Good predicate selection is strategic:

• Choose a predicate with similar indications, technology and risk profile — not just one that “got through.”
• Prefer predicates with clear, public 510(k) summaries and, ideally, related guidance or special controls.
• Avoid predicates with outdated technology or designs that are hard to defend if questioned.
• Consider if a single predicate is enough or if you need multiple predicate and/or reference devices to cover all aspects.

Weak predicate choices force contorted equivalence arguments and escalate data needs. Strong ones make your SE discussion almost boring — which is exactly the point.

6) Evidence Strategy: Bench, Software, Biocompatibility and Clinical

A 510(k) is only as strong as the evidence it sits on. That evidence should be defined in your design and risk planning, not improvised when someone starts filling in the “Performance Testing” section.

Typical elements include:

• Bench testing: mechanical, electrical, functional performance against design requirements and applicable standards (for example IEC, ISO, ASTM).
• Biocompatibility: per ISO 10993 framework; backed by material information, extraction studies and toxicological evaluation.
• Electrical safety & EMC: including basic safety and essential performance (e.g. IEC 60601‑1 series) for powered devices.
• Software verification & validation: structured testing and hazard analysis tied to software level of concern; evidence that the software does what it should and fails safely.
• Sterilization & packaging validation: where relevant, including shelf‑life support.
• Clinical data: for many 510(k)s, not required beyond literature and well‑constructed rationale — but when new questions of safety/effectiveness arise, clinical data may be the only credible path.

Underlying all of this is method validity: test method validation, calibrated equipment and controlled laboratories. “We tested it” is meaningless if your methods are not proven to be capable and reliable.

7) Design Controls, DHF and DMR Linkage

FDA expects that your 510(k) story and your design‑control story are the same story seen from two angles. That’s where the classic files come in:

• DHF: the evidence that design was defined, reviewed, verified and validated under controlled procedures.
• DMR: the specification for how the cleared device will actually be built, inspected, labeled and serviced.
• DHR: the records that show each batch or unit was built and tested according to that DMR.

A 510(k) that can’t point cleanly into DHF and DMR for key claims (requirements, risk controls, verification results, process capability, labeling) is a red flag. It suggests that RA is curating a narrative that the QMS cannot naturally support — and an inspector will eventually notice that gap when they walk your design‑control and production records.

8) Risk Management and ISO 14971 Alignment

Modern 510(k)s are expected to show that risk management is systematic, not decorative. That means:

• Hazards, hazardous situations and harms identified and evaluated per ISO 14971.
• Risk controls aligned to design features, protective measures and information for safety (warnings/IFU).
• Residual risks documented, with benefit–risk justification where appropriate.
• Specific focus on risks introduced by differences vs predicate: new materials, connectivity, algorithms, use environments.

Risk files that are obviously created at the end just to tick a box — unrealistic probabilities, copy‑paste harms, no link to testing — undermine the entire 510(k) argument. Risk management is supposed to drive what you test and what you claim, not trail behind as a tidy‑up exercise.

9) Labeling, Indications and Claims Discipline

For FDA, the device is defined just as much by what you say about it as by the hardware and software. That’s why 510(k) review pays close attention to:

• Indications for use: must match what you are actually designing, testing and risk‑assessing.
• Instructions for use (IFU): must be consistent with human‑factors assumptions, training models and residual risks.
• Warnings, precautions and contraindications: must reflect risk analysis and not introduce contradictions.
• Promotional claims: must stay within the cleared indications; “marketing creep” post‑clearance is a reliable way to attract enforcement.

This is why labeling control and change control are non‑negotiable in a device QMS. If marketing can change claims without structured impact assessment, the 510(k) you filed stops matching the device you’re actually selling.

10) Submission Format, Interactions and Review Flow

Operationally, your 510(k) journey looks roughly like this:

• Pre‑submission (Q‑Sub, optional but often smart): get feedback on your proposed indications, predicates, testing strategy and whether clinical data will be expected.
• Prepare and submit 510(k): increasingly using FDA’s eSTAR templates, which enforce structure and completeness.
• Acceptance review: FDA checks basic completeness against their Refuse‑to‑Accept (RTA) criteria.
• Substantive review: detailed evaluation; may result in requests for additional information (AI letters) or interactive review.
• Decision: Substantial Equivalence (SE) or Not Substantially Equivalent (NSE); SE leads to a cleared 510(k) and public summary.

From a system perspective, the critical thing is version control and traceability: which DHF/DMR versions you submitted, how AI responses were generated and approved, and how the final cleared specs are locked into your QMS so the marketed device actually matches what FDA cleared.

11) Common Failure Modes and FDA Deficiency Themes

If you read 510(k) deficiency letters and NSE decisions, a familiar pattern emerges. Typical issues include:

• Poor predicate choice or unclear substantial‑equivalence rationale.
• Unclear or overly broad indications for use that don’t match evidence.
• Insufficient performance testing, or tests not worst‑case and not aligned to risk.
• Biocompatibility or sterilization claims unsupported by appropriate studies or rationales.
• Software documentation gaps, especially around cyber‑security, reliability and anomaly handling.
• Risk management not linked to design and testing; residual risks not justified.
• Labeling inconsistent with device design, risk assumptions or submitted evidence.

All of these are easier to prevent than to fix in an AI response under time pressure. They are symptoms of weak design planning and cross‑functional integration, not just a “bad submission writer.”

12) Implementation Roadmap & Practice Tips for 510(k)

For organisations that still treat 510(k) as a late‑stage RA project, a more sustainable approach looks like this:

• 1. Lock the regulatory strategy early. Classification, predicate concept, indications and key guidance documents should be baselined before design decisions harden.
• 2. Embed 510(k) structure in the DHF. Organise design outputs, risk files and test reports so they naturally map to submission sections.
• 3. Plan evidence up front. For each major requirement and risk, define what testing or analysis will be needed to support 510(k) claims.
• 4. Use pre‑subs intelligently. Don’t ask FDA to design your device, but do get alignment on controversial indications, novel tech, or borderline predicates.
• 5. Industrialise change control. Post‑clearance, ensure every design/labeling/process change includes a documented 510(k) impact assessment.
• 6. Treat deficiencies as CAPA inputs. If FDA asks for the same clarifications repeatedly, fix the underlying templates, training and QMS, not just the one file.
• 7. Make RA, R&D, Quality and Manufacturing one team. The 510(k) should describe a device that can be built, inspected, supported and recalled if needed — not an imaginary device that only exists in PowerPoint.

The goal is simple: every 510(k) is a packaging exercise of well‑controlled design and QMS evidence, not a heroic reconstruction project.

13) What This Means for V5

On the V5 platform, a 510(k) submission is not “a PDF you assemble in isolation.” It becomes the natural output of how design, risk, manufacturing and quality live on a shared data model. V5 doesn’t submit to FDA for you — but it makes it much easier to prove that the device you describe to FDA is the same device your plant actually makes.

• V5 Solution Overview
  • Provides a unified model for products, BOMs, processes, lots, quality events and records, so 510(k) data can be traced back to live objects rather than disconnected spreadsheets.
  • Supports multi‑site, multi‑product portfolios where predicates, families and variants share controlled design and manufacturing elements.
• V5 QMS – Quality Management System
  • Holds the controlled procedures for design control, change control, risk management, CAPA and internal audits that underpin 510(k) credibility.
  • Manages the design‑control record set (DHF elements) as structured objects: requirements, reviews, verification/validation protocols and reports, risk analyses.
  • Links 510(k)‑relevant changes (design, labeling, manufacturing) to impact assessments and approvals, including flags for “new 510(k) required?” decisions.
• V5 MES – Manufacturing Execution System
  • Executes the cleared DMR as electronic work instructions and recipes, ensuring that the as‑built device matches the configuration described in the 510(k).
  • Captures electronic DHR data (materials, parameters, test results, operator sign‑offs) under Part 11‑compliant controls.
  • Feeds nonconformances and deviations back into V5 QMS, closing the loop between post‑market performance and future design/510(k) updates.
• V5 WMS – Warehouse Management System
  • Controls lot genealogy and component traceability, so you can link specific 510(k)‑cleared configurations to actual shipments and fielded units.
  • Manages segregation of variants, UDI‑coded packaging and hold/release status for finished devices under a single traceability model.
• V5 Connect API
  • Integrates design and quality data with PLM, ERP and LIMS so 510(k)‑relevant evidence (CAD, simulations, lab results, complaint trends) can be assembled without manual file‑chasing.
  • Supports controlled data exchange with partners and OEMs where shared 510(k) responsibilities, contract manufacturing or component supply chains exist.

Net effect: when you need to prepare a new 510(k) or update one, V5 gives you a living DHF/DMR/DHR and risk backbone. Instead of asking “Where is the latest version of that risk analysis and who changed the labeling?”, you’re exporting tables and evidence from a system that already enforces those relationships in daily work.

FAQ

Q1. Is a 510(k) “easier” than a PMA?
Generally yes — the 510(k) pathway is designed for devices that can rely on substantial equivalence rather than full de novo clinical demonstration. But “easier” doesn’t mean casual; weak design controls, risk management or testing will still stall or sink a 510(k).

Q2. Do all Class II devices need a 510(k)?
No. Some Class II devices are exempt, and some borderline cases may follow De Novo or other routes. Classification and exemption analysis should be part of your early regulatory strategy, not inferred from what competitors seem to be doing.

Q3. How often does a change require a new 510(k)?
There is no simple percentage rule. Each change must be assessed for its potential impact on safety, effectiveness, indications and technology. If those impacts are material, or introduce new risks/questions, a new 510(k) is usually the conservative and defensible route.

Q4. Can we submit a 510(k) if our QMS is still maturing?
You can, but it’s risky. FDA may inspect after clearance, and any mismatch between the QMS you describe in the submission and the reality on the floor will be painfully obvious. It is smarter to bring at least design control, risk management, document control and production controls up to a solid baseline first.

Q5. What’s the most reliable way to reduce 510(k) review pain?
Do the hard thinking up front: sharp indications, sound predicate choice, realistic risk analysis, deliberate test strategy, and tight integration between design, quality and manufacturing. A clean, boring submission built on strong evidence is far more “review‑friendly” than a clever narrative trying to compensate for missing foundations.

Related Reading
• Design & Files: Design History File (DHF) | Device Master Record (DMR) | Device History Record (DHR)
• QMS & Risk: Quality Management System (QMS) | ISO 13485 | ISO 14971 | Quality Risk Management (QRM) | Change Control
• Regulatory & Data: 21 CFR 820 / QMSR | 21 CFR 11 | UDI | Data Integrity
• V5 Platform: V5 Solution Overview | V5 QMS | V5 MES | V5 WMS | V5 Connect API