510(k) Medical Device Submission
A Student’s Practical Guide
What the 510(k) process actually involves, how to structure an assignment on it, where most students go wrong, and how to find and use the right regulatory sources. No jargon padding — just the process, laid out clearly.
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Get Expert Help →What the 510(k) Actually Is — and Why It Matters for Your Assignment
A 510(k) — formally called a Premarket Notification — is a submission to the US Food and Drug Administration (FDA) that a medical device manufacturer must file before legally marketing most Class II devices and some Class I devices in the United States. The name comes from Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The submission must demonstrate that the new device is substantially equivalent to a legally marketed device already on the US market — known as the predicate device.
Here is the thing students often get tripped up on immediately: the 510(k) does not prove a device is safe and effective on its own merits. It proves the device is comparable to something the FDA has already allowed. That distinction is fundamental to understanding every part of the process — the documents you need, the arguments you make, and the common submission failures you will study.
The 510(k) pathway exists because requiring every new device to go through the full Premarket Approval (PMA) process — which demands independent clinical evidence of safety and effectiveness — would be impractical for the tens of thousands of lower-risk devices that evolve incrementally each year. A slightly improved blood pressure cuff does not need the same scrutiny as a new heart valve. The 510(k) is the mechanism that handles that distinction.
If you are writing about this for a biomedical engineering, regulatory affairs, health sciences, or MBA in medical technology program, your assignment is almost certainly asking you to do one of three things: explain the process, analyse a real or hypothetical device’s pathway through it, or critically evaluate its regulatory adequacy. This guide covers how to handle all three.
Process Analysis
Walk through each stage of submission — device classification, predicate selection, testing, documentation — and explain what regulatory standards apply at each point.
Device-Specific Case Study
Apply the 510(k) framework to a real or hypothetical device. Identify its classification, find a credible predicate, and outline the testing and documents required.
Critical Regulatory Analysis
Evaluate the strengths and weaknesses of the 510(k) pathway. Compare it to PMA, examine reform debates, and take a position on whether it provides adequate patient protection.
Comparative Regulatory Study
Compare the FDA 510(k) pathway to the EU MDR CE marking process, Health Canada, or other international frameworks for equivalent device approval.
The FDA’s 510(k) Database Is a Primary Source — Use It
The FDA maintains a publicly searchable database of all cleared 510(k) submissions at accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. This is not a secondary source — these are the actual clearance decisions, decision summaries, and special 510(k) summaries. If your assignment involves a real device, find its clearance record. If it involves a hypothetical device, search for cleared predicates in the same device category. Using the actual database makes your analysis concrete and demonstrably grounded in regulatory reality. That is the difference between a good assignment and an excellent one.
FDA Medical Device Classes — Getting This Right Before Anything Else
Before you write a word about 510(k) submissions, you need to be precise about device classification. The FDA classifies all medical devices into three classes based on risk level and the regulatory controls needed to provide reasonable assurance of safety and effectiveness. Which class a device falls into determines whether it even needs a 510(k) in the first place.
Low Risk
- Subject to general controls only
- Most exempt from 510(k)
- Examples: bandages, tongue depressors, elastic bandages
- ~47% of all devices
- Some non-exempt Class I do require 510(k)
Moderate Risk
- Subject to general and special controls
- Most require 510(k) clearance
- Examples: X-ray systems, powered wheelchairs, infusion pumps
- ~43% of all devices
- Core focus of 510(k) pathway
High Risk
- Requires Premarket Approval (PMA)
- Independent clinical evidence required
- Examples: pacemakers, heart valves, cochlear implants
- ~10% of all devices
- 510(k) pathway generally does not apply
One critical nuance your assignment should address: some Class III devices entered the market before the 1976 Medical Device Amendments established this classification system. These devices — called “preamendment” devices — can sometimes serve as 510(k) predicates even though they are technically Class III, because they were never required to go through PMA. This is a real regulatory quirk that critics of the 510(k) pathway frequently cite as a problem. If your assignment asks you to critically analyse the pathway, this is worth addressing.
How to Determine a Device’s Classification
The FDA uses a system of Product Codes and Regulation Numbers to classify devices. Each device category has a specific product code (a three-letter code like “FRN” for certain blood glucose monitors). You find a device’s product code through the FDA’s Product Classification database at accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. The product code tells you the device’s classification, the applicable regulation number in 21 CFR Part 800–899, and whether it is subject to special controls or performance standards. For any case study assignment, locating the correct product code for your device is the first and most important step.
The De Novo Pathway — A Third Route Worth Knowing
If a device is novel — no legally marketed predicate exists — and is low-to-moderate risk, it cannot use the 510(k) pathway. But it also may not require a full PMA. The De Novo pathway allows the FDA to create a new device type, assign it a product code and classification, and clear the device. Once cleared via De Novo, that device itself becomes a legal predicate that future devices can reference in a 510(k). If your assignment covers novel devices or FDA regulatory reform, the De Novo pathway is essential context.
How a 510(k) Submission Actually Works — Step by Step
The 510(k) process is not something you guess at — the FDA publishes detailed guidance documents for every stage of it. If your assignment requires a process analysis, the correct approach is to work through each stage sequentially and cite the applicable FDA guidance at each point. Here is how the process runs.
Determine Whether a 510(k) Is Required
Not every device needs one. The manufacturer must first confirm the device requires FDA clearance at all — by identifying its classification. If it is an exempt Class I or II device, the 510(k) pathway does not apply. If it is a Class III device not previously cleared or approved, it will likely need a PMA, not a 510(k). The decision tree here is governed by 21 CFR 807.87 and the FDA’s guidance on “Is a 510(k) Required.” Getting this stage wrong in an assignment is a significant conceptual error.
Identify a Predicate Device
This is where the substantial equivalence argument begins. The manufacturer must identify at least one legally marketed predicate device — either a device cleared through a previous 510(k), a preamendment Class III device, or a De Novo-classified device. The predicate must have the same intended use as the new device. Predicate selection is genuinely strategic: a well-chosen predicate makes the substantial equivalence argument straightforward; a poorly chosen one creates technical problems throughout the submission. For case study assignments, finding a real predicate using the 510(k) database is what separates good from excellent work.
Conduct Required Testing and Gather Performance Data
What testing is required depends entirely on the device type, the differences between the new device and the predicate, and whether FDA-recognised consensus standards exist for the device category. Testing categories typically include biocompatibility testing (ISO 10993 series), electrical safety testing (IEC 60601), performance testing specific to the device type, and sterility or packaging testing where relevant. The FDA recognises hundreds of voluntary consensus standards — if a manufacturer follows a recognised standard, they can submit a Declaration of Conformity rather than full test reports. Your assignment should identify which standards apply to a given device type.
Prepare the 510(k) Submission Package
The FDA specifies the required sections of a 510(k) submission in 21 CFR 807.87 and the guidance document “Refuse to Accept Policy for 510(k)s.” A complete submission includes the device description, intended use statement, substantial equivalence comparison, performance data, labelling, and applicable declarations of conformity with recognised standards. The submission is filed electronically through the FDA’s eSTAR (electronic Submission Template and Resource) system. Missing a required section is grounds for Refuse to Accept (RTA) — the FDA will not begin its substantive review until the submission is complete.
FDA Acceptance Review
Once the submission is filed, the FDA conducts a preliminary acceptance review within 15 days to confirm it is complete. If it fails this review — called an RTA — the submitter must correct and resubmit. The 90-day review clock does not start until the FDA accepts the submission. This is why submission quality matters: an RTA adds weeks or months to the overall timeline and can be commercially costly. For assignments on regulatory strategy, the RTA rate for a given device category (available in FDA performance data) is a meaningful indicator of submission complexity.
Substantive Review and FDA Decision
The FDA’s target is to complete its substantive review within 90 days of acceptance. During this period, the reviewer may issue an Additional Information (AI) request — asking the manufacturer for more data or clarification. Responding to an AI request pauses the review clock. The FDA’s final decision is one of three outcomes: Substantially Equivalent (SE) — device is cleared; Not Substantially Equivalent (NSE) — device is not cleared and cannot be marketed; or a request to reclassify the device. An NSE decision does not mean the device can never reach the market — the manufacturer can go back, find a different predicate, conduct additional testing, or pursue the De Novo pathway.
510(k) Clearance Is Not FDA Approval — This Distinction Matters
One of the most common errors in student assignments is using the words “approval” and “clearance” interchangeably for the 510(k). The FDA is precise about this. Devices cleared through the 510(k) process are cleared, not approved. Only devices that go through the Premarket Approval (PMA) process are technically “FDA approved.” The distinction matters legally, commercially, and in public communication. Calling a 510(k)-cleared device “FDA approved” is technically inaccurate and has been the subject of FDA warning letters to companies. In any regulatory affairs assignment, using these terms correctly is a basic test of whether you understand the process.
Substantial Equivalence — The Argument Your Submission Must Make
If the 510(k) process has a centre of gravity, it is this concept. Understanding what substantial equivalence means legally and practically is the most important analytical task in any 510(k) assignment. The FDA’s definition comes from Section 513(i) of the FD&C Act and is worth working through carefully.
A device is substantially equivalent to a predicate if it meets both of the following conditions. First, it has the same intended use as the predicate device. Second, it either has the same technological characteristics as the predicate, OR it has different technological characteristics but those differences do not raise new questions of safety and effectiveness, and the device is at least as safe and effective as the predicate.
That second condition is where the analytical work lives. The FDA has published a guidance document specifically on this — “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications” (2014, updated) — and it walks through the decision logic in a flowchart that is genuinely useful to cite in assignments. The logic goes: same intended use? If no, NSE. If yes, same technological characteristics? If yes, SE. If no — do the different characteristics raise new safety or effectiveness questions? If yes, NSE. If no, and performance data supports equivalence, then SE.
The 510(k)’s fundamental premise is that a device’s risk profile is adequately captured by its similarity to what already exists — a reasonable assumption for incremental innovation, a contested one for genuinely novel technologies.
— Paraphrased synthesis from Zuckerman et al., “Medical Device Recalls and the FDA Approval Process,” Archives of Internal Medicine (2011)What “Same Intended Use” Actually Means
Intended use is not the same as indications for use, though the two are related. Intended use refers to the general purpose of the device — what disease or condition it is designed to diagnose, treat, cure, mitigate, or prevent. Indications for use are more specific — they describe the patient population, the clinical context, and the specific conditions under which the device is used. A new cardiac monitoring device and an existing one might share an intended use (monitoring cardiac rhythm) but have different indications (one might be indicated for adult ICU patients, the other for ambulatory use). Assignments that conflate these two concepts will miss important nuance in the substantial equivalence analysis.
When Different Technological Characteristics Become a Problem
This is where many 510(k) submissions — and many student analyses — get complicated. The FDA does not define “technological characteristics” narrowly. Materials, design, energy source, operating principles, and software components all count. A device that uses a fundamentally different operating principle from its predicate — even if it achieves the same intended use — faces a much higher evidentiary burden. It needs to demonstrate that the new technology does not introduce new risks AND that it performs at least as well as the predicate. For software-based medical devices and AI/ML-enabled devices in particular, demonstrating substantial equivalence to older, non-software predicates has become one of the most contested areas in FDA regulatory practice.
A Real Controversy Worth Analysing — The “Predicate Creep” Problem
Critics of the 510(k) system — including researchers who published influential analyses in the Journal of the American Medical Association and Congressional investigators — have documented a phenomenon called “predicate creep.” Because a cleared device can itself become a predicate for the next generation, and that device can become a predicate for the one after, it is theoretically possible for a 2025 device to trace its regulatory lineage back through a chain of 510(k) clearances to a 1970s preamendment device that was never tested against modern safety standards. If your assignment asks you to critically evaluate the 510(k) pathway, this argument — and the FDA’s responses to it — is the central analytical territory.
The Three Types of 510(k) — and When Each Applies
The FDA offers three distinct 510(k) pathways, and which one a manufacturer uses depends on the device’s novelty and the strength of the available performance data. Your assignment should distinguish between them clearly.
| Submission Type | When It Applies | Key Advantage | Key Requirement |
|---|---|---|---|
| Traditional 510(k) | Standard pathway for most devices — when no other pathway is available or applicable | Flexibility in how substantial equivalence is demonstrated; most accepted pathway | Full submission package per 21 CFR 807.87; most comprehensive documentation required |
| Abbreviated 510(k) | Device conforms to FDA-recognised guidance documents, special controls, or mandatory performance standards | Allows manufacturer to reference recognised standards rather than submitting full test data; streamlines review | Declaration of conformity for each referenced standard; summary report of how device meets the guidance |
| Special 510(k) | Manufacturer is modifying their own previously cleared device — same intended use, same or similar technological characteristics | Faster review process; 30-day FDA target review time; reduced documentation burden | Design control documentation demonstrating the modification does not raise new safety questions; only available to the original 510(k) holder |
The Special 510(k) pathway is particularly relevant for assignments on iterative product development or design control systems. It essentially allows a company to update its own cleared device — changing software, materials, or design — without filing a full new 510(k), provided they can demonstrate through their design control process that the change is within the bounds of the original clearance. This is where ISO 13485 (quality management systems for medical devices) intersects with FDA regulatory strategy — a connection worth making explicit in graduate-level assignments.
Key Documents in a 510(k) Submission — What Each One Must Do
The FDA’s 2019 guidance “Refuse to Accept Policy for 510(k)s” lists every required element of a complete submission. Missing elements result in an automatic RTA decision before the substantive review even begins. For assignments requiring a submission plan or document analysis, work through these in order.
| Document Section | Purpose | Common Mistakes |
|---|---|---|
| Cover Letter / Cover Sheet | Identifies the submitter, device type, submission type, and applicant contact; signals to FDA reviewers what they are about to read | Using wrong submission type designation; omitting required identifiers from the eSTAR system |
| Table of Contents | Maps the submission to the FDA’s required format so reviewers can navigate efficiently | Not matching actual section structure; outdated section references after document revision |
| Indications for Use Statement | Precisely defines the intended patient population, clinical setting, and conditions of use — this is the scope of the clearance | Making it so broad it cannot be supported by data; making it so narrow it fails to cover the actual use case |
| Device Description | Technical description of the device — components, materials, operating principle, accessories; must enable a reviewer to fully understand what they are evaluating | Omitting software descriptions for software-containing devices; vague materials characterisation |
| Substantial Equivalence Comparison | Side-by-side comparison of the new device and predicate — intended use, technological characteristics, and performance — with the SE argument explicitly stated | Weak predicate selection; failing to address technological differences head-on; using multiple predicates without clear justification |
| Performance Testing Data | Bench testing, biocompatibility data, electrical safety data, clinical data (where required) — the evidence that the device performs as claimed | Using non-recognised test standards without justification; failing to include worst-case testing conditions |
| Labelling | Final intended labelling — must accurately reflect the cleared indications for use and include required safety warnings | Submitting draft rather than final labelling; inconsistency between labelling claims and testing data |
| Declaration of Conformity (if applicable) | For abbreviated 510(k)s — formal declaration that the device conforms to each referenced FDA-recognised standard | Referencing outdated standard editions; failing to note deviations from the standard |
How to Find Real 510(k) Submissions for Your Assignment
- Go to accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
- Search by device name, product code, or applicant company
- Look for “Decision Summary” documents — these are the FDA’s own analysis of the submission
- Look for “Summary” documents — manufacturers often publish a public summary of their submission
- Use the product code to search for all cleared devices in the same category — this shows you what predicates exist
- Cross-reference with the FDA’s 510(k) Performance Dashboard for review time data by device type
How Long It Takes — And What the Data Actually Shows
Students often cite “90 days” as the 510(k) review time and leave it there. That is technically the FDA’s statutory review target — but the real picture is more complicated and more interesting for analytical purposes.
What the 90 Days Covers
- Starts on date of acceptance, not date of submission
- FDA target only — not a guarantee
- Clock pauses during AI request response periods
- Applies to substantive review only
- FDA publishes quarterly performance data showing actual achievement
What Gets Added On Top
- 15-day acceptance review before clock starts
- AI requests can pause clock for weeks or months
- Total submission-to-clearance often 4–6 months
- Complex devices and novel technologies can run 12+ months
- RTA rejection and resubmission resets entire timeline
According to FDA performance data published in the 510(k) and De Novo Performance Report, the average total time from receipt to decision for traditional 510(k)s has historically ranged from 100 to 135 days for the review period — excluding time spent waiting for additional information from applicants. When those hold periods are included, total elapsed time is considerably longer. The FDA publishes this data annually and it is worth citing directly in any assignment that covers regulatory timelines, because the difference between statutory targets and actual performance is itself a regulatory policy issue.
Third-Party Review — An Accelerator Worth Knowing
Since 1998, the FDA has accredited third-party review organisations to conduct the initial substantive review of certain low-to-moderate-risk 510(k) submissions — typically straightforward Class II devices without novel features. Third-party reviewers aim for a 30-day review, after which the FDA has 15 days to accept or reject the recommendation. In practice, total time from submission to clearance via third-party review is often 60–90 days total — significantly faster than the standard pathway. For assignments on regulatory strategy or market access timelines, this pathway is worth including.
How to Tackle a 510(k) Assignment — Practical Guidance
Regulatory affairs assignments on the 510(k) process have a specific structure problem: the topic is both highly procedural and highly analytical. Students who write purely procedurally — listing steps without analysis — miss the critical thinking marks. Students who analyse without procedural grounding come across as vague. The goal is to do both, in the right sequence.
Pin Down Your Assignment Type Before You Research
Process analysis, case study, and critical evaluation assignments require different source types and different structures. A process analysis needs the FDA’s guidance documents and regulations as primary sources. A case study needs the actual 510(k) database. A critical evaluation needs peer-reviewed regulatory science literature. Knowing which you are writing first will save you significant time. Reread your brief, identify the key verb — “describe,” “apply,” “evaluate,” “compare” — and let that determine your approach.
Use FDA Primary Sources, Not Just Textbook Summaries
The FDA publishes guidance documents, regulations, performance data, and the full 510(k) database all for free. These are primary regulatory sources. Citing a textbook’s summary of the 510(k) process when the actual FDA guidance document is available and citable is a missed opportunity. The FDA’s guidance on “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications” (2014), the “Refuse to Accept Policy for 510(k)s” (2019), and the “Format for Traditional and Abbreviated 510(k)s” are the foundational documents. Cite the actual FDA documents by their title and date.
Structure the Substantial Equivalence Argument Explicitly
If your assignment includes a case study, the substantial equivalence analysis is where you demonstrate that you actually understand the process — not just know its name. Work through it step by step: identify the predicate and justify why it is a valid choice, compare intended uses explicitly, list the technological differences, and then make the argument — with reference to data — for why those differences do or do not raise new safety questions. Use the FDA’s own SE decision logic flowchart as your structural guide. Show your reasoning, not just your conclusion.
Engage with the Regulatory Debates, Not Just the Process
If your assignment has any critical evaluation component, the peer-reviewed literature on 510(k) reform is rich and accessible. Research by Zuckerman, Fargen, and others published in JAMA, Archives of Internal Medicine, and BMJ has documented concerns about predicate creep, recalled devices that were cleared via 510(k), and the adequacy of the SE standard for increasingly complex technologies. The FDA has also published its own reform initiatives — the Medical Device Safety Action Plan (2018) and the CDRH Strategic Priority Reports. Engaging with this debate at a graduate level is what makes the difference between a descriptive and an analytical assignment.
Compare International Frameworks Where Relevant
The EU’s Medical Device Regulation (EU MDR 2017/745) replaced the older MDD/IVDD frameworks and takes a substantially different approach to market access for medical devices — requiring clinical evaluation reports and conformity assessments by independent notified bodies rather than substantial equivalence demonstrations. Health Canada and Australia’s TGA have their own frameworks. If your assignment asks for comparative analysis, the structural differences — SE-based clearance versus clinical evaluation-based conformity assessment — and their implications for innovation timelines and patient safety are the analytical core. Do not just describe both systems; argue for what the differences mean.
Verified External Sources for 510(k) Assignments
- FDA CDRH: fda.gov/medical-devices — guidance documents, regulations, the 510(k) database, and performance data
- Zuckerman, DM et al. (2011): “Medical Device Recalls and the FDA Approval Process,” Archives of Internal Medicine 171(11) — foundational critical analysis of the 510(k) pathway
- FDA 510(k) and De Novo Performance Report: Published annually by CDRH — actual review time data by device type
- EU MDR 2017/745: eur-lex.europa.eu — comparative EU regulatory framework
- IMDRF (International Medical Device Regulators Forum): imdrf.org — international regulatory convergence documents
- RAPS (Regulatory Affairs Professionals Society): raps.org — practitioner-level regulatory affairs resources and regulatory intelligence
Common Errors Students Make in 510(k) Assignments — and How to Fix Them
| ❌ Common Error | Why It Matters | ✓ The Fix |
|---|---|---|
| Using “FDA approved” for a 510(k)-cleared device | Factually wrong and demonstrates a fundamental misunderstanding of the regulatory pathway — a basic mark-losing error | Use “FDA cleared” or “510(k) cleared” for devices that went through the 510(k) process; reserve “FDA approved” for PMA devices only |
| Describing the process without citing FDA guidance documents | FDA guidance is the primary source — citing only textbooks signals that you have not engaged with the actual regulatory framework | Cite FDA guidance documents by title and date: “FDA Guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (2014)” and 21 CFR 807.87 for the required submission content |
| Treating substantial equivalence as a synonym for “similar” | SE is a legally defined standard with a specific two-part test — treating it as informal similarity misses the regulatory logic entirely | Define SE precisely using the FD&C Act definition; work through the two-part test (same intended use + same/equivalent technological characteristics with no new safety questions) |
| Ignoring the role of product codes and regulations | Device classification drives the entire submission pathway — without identifying the correct product code and regulation number, a case study analysis lacks grounding | Use the FDA Product Classification database to identify the device’s product code, applicable 21 CFR regulation, and any device-specific special controls or performance standards |
| Confusing the three 510(k) types | Traditional, Abbreviated, and Special 510(k)s have different requirements, timelines, and applicable situations — conflating them shows process misunderstanding | Define each type clearly, state when each applies, and in case studies, justify which pathway is appropriate for the specific device and situation |
| Not engaging with 510(k) controversies in critical assignments | A critical analysis that only describes the process and says it “generally works well” is not analysis — it is description with a label | Engage with documented concerns — predicate creep, recalls of 510(k)-cleared devices, AI/ML device challenges — citing the peer-reviewed literature that documents them, and present the FDA’s own reform responses fairly |
| Leaving software out of the device description | Software as a Medical Device (SaMD) has specific FDA regulatory requirements — ignoring software in a device case study is a significant omission for any device with a digital or software component | For software-containing devices, reference the FDA’s Digital Health Center of Excellence guidance and the “Software as a Medical Device (SaMD): Clinical Evaluation” guidance; identify whether the software functions as a device in its own right |
Pre-Submission Checklist for 510(k) Assignments
- Cleared vs. approved: consistent and correct throughout
- Device classification identified using product code — not assumed
- FDA guidance documents cited as primary sources
- Substantial equivalence analysis follows the two-part legal test
- Predicate device identified from the actual 510(k) database (for case studies)
- Applicable testing standards (ISO, IEC) identified for the device type
- 510(k) type (Traditional / Abbreviated / Special) specified and justified
- Software components addressed if relevant
- Critical arguments (if required) supported by peer-reviewed regulatory science
- International regulatory comparison accurate (EU MDR, Health Canada, etc.) if included
FAQs: 510(k) Medical Device Submission
The 510(k): A Process Worth Understanding Precisely
The 510(k) pathway is not complicated at its core — it is a mechanism for leveraging existing regulatory decisions to reduce the burden on incremental innovation. What makes it complex is the intersection of legal standards, technical evidence requirements, strategic predicate selection, and genuine regulatory policy debates about whether “similar to what already exists” is a robust enough standard for devices that patients depend on.
For your assignment, the difference between a decent grade and a strong one comes down to a few things. Using FDA primary sources rather than textbook summaries. Getting the cleared/approved distinction right consistently. Working through the substantial equivalence analysis as a structured argument rather than a label. And, if the assignment calls for it, engaging honestly with the real debates in the regulatory science literature.
The FDA’s 510(k) database, guidance documents, and performance reports are all free, public, and directly citable. There is no excuse — and no substitute — for using them.
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