Checklist · Healthcare

Bringing a Device to Market or Pursuing a Device Injury Claim: A Practical Checklist

21 U.S.C. § 360

Type
Checklist
Jurisdiction
National
Date
2025-10-07
Topic
Healthcare

This checklist runs a medical device matter from either direction. For the injury claim it opens with the pathway determination that decides whether a case exists at all, then the public record search that can be completed before filing, the timeline that identifies what the manufacturer knew and when, and the explant preservation protocol that decides more device cases than any legal argument. It sets out how to plead a parallel claim against an approved device with the specificity strict jurisdictions demand, and how to answer the learned intermediary defense. For the manufacturer it covers the intended use statement, the classification and pathway decision as a permanent liability choice, design controls, corrective action with effectiveness verification, reporting, and recall procedure. A diagnostics section separates laboratory failures from test failures.

Bringing a Device to Market or Pursuing a Device Injury Claim: A Practical Checklist

Healthcare > Medical Devices, Diagnostics, and Laboratory Testing | Published 7 October 2025 - Updated 16 July 2026 | UpLaw - uplaw.us

Which part do you need?

☐ An injury claim — Parts 1-7. ⚠️ Start with the pathway, not the injury. ☐ Bringing a device to market — Parts 8-10. ☐ A diagnostic or laboratory problem — Part 11. ☐ Defending — Part 12.

⚠️ The orienting fact: liability tracks the regulatory pathway, not the harm. The most rigorously reviewed devices are the hardest to sue over. Any analysis that reasons from injury severity to claim strength will be wrong here more often than anywhere else in product law.

Part 1 — Pathway determination

☐ Identify the device — brand ☐ model ☐ manufacturer ☐ product code ☐ unique device identifier ☐ lot ☐ serial ☐ ☐ Classification confirmed under 21 U.S.C. § 360c ☐ Class ☐ I ☐ II ☐ III ☐ Pathway: • ☐ Premarket notification (cleared) → Medtronic, Inc. v. Lohr: traditional claims generally survive. Registration and notification under 21 U.S.C. § 360 and 21 C.F.R. Part 807. • ☐ Premarket approval → Riegel v. Medtronic, Inc.: design, warning, and strict liability claims preempted under 21 U.S.C. § 360k. Approval under 21 U.S.C. § 360e, procedures at 21 C.F.R. Part 814. • ☐ Exempt Class I ☐ Risk-based classification for a novel device ☐ Investigational ☐ Device or drug? — chemical action or metabolism makes it a drug; check the definition at 21 U.S.C. § 321 ☐ combination product? lead center? ______ ☐ ⚠️ Do this before evaluating the medicine. The answer determines whether there is a claim.

Part 2 — The public record, before filing

☐ Clearance or approval summary obtained ☐ Approval order and all supplements for an approved device ☐ ☐ ⚠️ PREDICATE CHAIN TRACED — each predicate, its clearance date, and whether any was later recalled ☐ Compare the stated intended use across generations. An indication that expanded incrementally without new clinical evidence is a story the public record tells. ☐ Adverse event database searched — by device ☐ manufacturer ☐ product code ☐ brand ☐ Reporting duties at 21 U.S.C. § 360i, rules at 21 C.F.R. Part 803. • ⚠️ Look for a PATTERN PREDATING your client's injury, not a single event ☐ • Note the limits honestly: unverified, duplicative, no denominator. They prove notice, not rates ☐ ☐ Corrections and removals reports under 21 C.F.R. Part 806 ☐ ☐ Recall notices obtained — classification ☐ affected lot and date ranges ☐ manufacturer's own description of the problem ☐ Authority at 21 U.S.C. § 360h. ☐ Inspection observations and warning letters for the manufacturing site ☐ ⚠️ A warning letter citing inadequate corrective action, dated before the implant, is close to a pleaded parallel claim.

Part 3 — The timeline

Event Date
Device first cleared or approved
First adverse event report of this failure mode
Warning letter or inspection observation
Client's implant
Symptom onset
Recall issued (and its date range)
Revision or removal

☐ ⚠️ THE INTERVAL BETWEEN THE FIRST SIGNAL AND THE MANUFACTURER'S RESPONSE IS THE CASE. ☐ If the implant predates the recall, the complaint file for the intervening period is the discovery target ☐

Part 4 — Preserve the explant

⚠️ This decides more device cases than any legal argument. Hospitals return failed implants to manufacturers as a matter of routine, where they are analyzed by the manufacturer's engineers and sometimes destroyed.

☐ 1. Before the revision surgery where possible, written preservation demand to the hospital ☐ the surgeon ☐ the operating room ☐ Retain the explant. Do not return it to the manufacturer. Do not clean or reprocess it. ☐ 2. Chain of custody from the moment of removal — who took it ☐ container ☐ label ☐ storage ☐ every transfer documented ☐ ☐ 3. ⚠️ No destructive testing without a written protocol agreed by all parties, with opposing experts able to observe ☐ ☐ 4. Photograph before any handling — device ☐ packaging ☐ labels ☐ identifiers ☐ ☐ 5. Capture identifiers — unique device identifier ☐ lot ☐ catalog ☐ serial ☐ These tie the client to a manufacturing run, a recall date range, and a complaint file. ☐ 6. Paired documents: operative report from implantation ☐ from revision ☐ implant log or sticker sheet ☐ device history record for that lot ☐ hospital purchasing records ☐ sales representative's notes ☐ ⚠️ A representative is often present in the operating room and keeps records nobody requests. ☐ ⚠️ A device case without the device is an argument about statistics. A device case with the device is an engineering case — and engineering cases settle.

Part 5 — Choosing defendants and theories

☐ Manufacturer ☐ Component supplier ☐ Distributor ☐ ☐ Reprocessor where a single-use device was reused ☐ ⚠️ Reprocessors are manufacturers for regulatory purposes, with their own obligations under 21 C.F.R. Part 820 and 21 C.F.R. Part 803. ☐ Hospital where handling, reprocessing, or credentialing is implicated ☐ ☐ Physician, in a separate malpractice claim under different rules, where technique, device selection, or consent is at issue ☐

For a CLEARED device ☐ design defect ☐ manufacturing defect ☐ failure to warn ☐ negligence ☐ misrepresentation ☐ express and implied warranty ☐

For an APPROVED device — the parallel claim only: ☐ ⚠️ Two conditions at once: it must not impose a requirement different from or in addition to federal law, and it must not exist solely because federal law was violated ☐ ☐ Shapes that work: • Manufacturing departure from the approved specifications or from 21 C.F.R. Part 820 ☐ • Failure to submit required reports under 21 U.S.C. § 360i, in a State recognizing a duty to warn through regulatory reporting ☐ • Failure to comply with a condition of approval, such as a required postapproval study ☐ ☐ ⚠️ NEVER plead fraud on the agency — Buckman Co. v. Plaintiffs' Legal Committee forecloses it, and it can taint otherwise viable claims ☐ ☐ ⚠️ Plead as though you are in the strictest jurisdiction: name the regulation ☐ the requirement ☐ the specific deviation ☐ the causal link ☐ ☐ Claims outside preemption — off-label promotion ☐ express warranties the manufacturer chose to make ☐ non-safety advertising claims under 15 U.S.C. § 45 and State consumer statutes ☐ ☐ Adulteration and misbranding predicates — 21 U.S.C. § 351 ☐ 21 U.S.C. § 352 ☐ prohibited acts 21 U.S.C. § 331 ☐

Part 6 — The learned intermediary defense

☐ Understand it: in most States the manufacturer's warning duty runs to the physician, not the patient ☐ ☐ Answer one — the physician's warning was itself inadequate ☐ what did the labeling disclose about this failure mode? ______ ☐ Answer two — the physician would have acted differently had the known failure rate been disclosed ☐ ☐ ⚠️ Depose the implanting surgeon early, and ask what they were told about failure rates — not whether they read the label ☐ ☐ Anticipate alternative causation — technique ☐ device selection ☐ patient anatomy and activity ☐ infection ☐ comorbidity ☐ postoperative compliance ☐

Part 7 — Clocks, liens, and aggregation

☐ State limitations ______ ⚠️ Repose ______ In some jurisdictions product claims run from implantation rather than discovery. ☐ Malpractice period where a physician is a defendant ______ notice of intent ☐ affidavit of merit ☐ ☐ Wrongful death and survival periods where applicable ☐ ☐ Liens quantified before any settlement number — health plan ☐ public payer ☐ provider ☐ ☐ Aggregation posture — is a coordinated proceeding forming? ☐ bellwether schedule? ☐ ⚠️ Filing timing relative to an emerging aggregation materially affects value. ☐ Damages built out — revision surgery and its complication rate ☐ extended recovery ☐ lost income ☐ permanent limitation ☐ life care plan where further revisions are foreseeable ☐ fear of future failure where the device remains implanted ☐ loss of consortium ☐ ☐ Punitive theory — complaint volume ☐ internal risk analyses ☐ deferred mitigations ☐ the gap between what was reported and what was known ☐

Part 8 — Bringing a device to market: the decisions

☐ ⚠️ WRITE THE INTENDED USE STATEMENT FIRST ______ Every regulatory question resolves from this sentence, and marketing must be held to it. ☐ Device or drug? — primary mode of action ☐ combination product ☐ lead center ______ (definition at 21 U.S.C. § 321) ☐ Is the software a device? — analyzes a signal, computes a diagnosis, or drives therapy → yes ☐ records, administration, general wellness, or display and storage → generally no ☐ ☐ Classification determined by product code and regulation, confirmed rather than assumed — 21 U.S.C. § 360c ☐ ☐ ⚠️ PATHWAY CHOSEN DELIBERATELY — THIS IS A PERMANENT LIABILITY DECISION • Notification: faster, cheaper, and forgoes preemption protection for the product's life • Approval: slower, expensive, and confers the Riegel shield ⚠️ Companies routinely make this trade without anyone in the room understanding the second half of it. ☐ Predicate identified and defensible ☐ intended use matches ☐ technological differences raise no new questions ☐ ☐ No predicate? → risk-based classification route for a novel low- or moderate-risk device ☐ ☐ Clinical study needed? → investigational device exemption ☐ review board oversight ☐ informed consent ☐ ☐ Registration and listing — 21 U.S.C. § 360, 21 C.F.R. Part 807 ☐ unique device identification ☐ labeling compliance ☐

Part 9 — Quality system, before first sale

21 C.F.R. Part 820

Design controls ☐ Design and development plan ☐ Design inputs (requirements) ☐ Design outputs (specifications) ☐ ☐ Design review at defined stages with an independent reviewer ☐ ☐ Verification (built it right) ☐ Validation under actual or simulated use conditions (built the right thing) ☐ ☐ Design transfer ☐ Design change control ☐ Design history file ☐ ☐ ⚠️ Risk analysis with mitigations actually IMPLEMENTED AND CLOSED ☐ The worst document in device litigation is a risk analysis naming the failure mode that injured the plaintiff beside a deferred mitigation.

Complaints and corrective action ☐ Formal complaint receipt, review, and evaluation by a designated unit ☐ ☐ Contemporaneous reportability determination, with the reasoning documented ☐ ☐ Investigation where a possible failure to meet specifications is involved ☐ ☐ Quality data analyzed — complaints ☐ returns ☐ service records ☐ process monitoring ☐ ☐ ⚠️ CAPA EFFECTIVENESS VERIFIED BEFORE CLOSURE ☐ Opening a corrective action looks good. Closing one without verifying it worked creates a document proving the company identified the failure and never confirmed the fix.

Postmarket ☐ Reporting under 21 C.F.R. Part 803 — manufacturer ☐ importer ☐ user facility obligations understood ☐ ☐ Corrections and removals under 21 C.F.R. Part 806 ☐ ☐ ⚠️ Report generously. Under-reporting is a violation, a parallel claim, and a credibility problem in one act. Over-reporting costs administrative effort and nothing else. ☐ Recall decision procedure written before it is needed — 21 U.S.C. § 360h ☐ ☐ Postapproval study commitments tracked ☐ ☐ Adaptive software? → predetermined change control plan describing permitted modifications, methodology, and impact assessment ☐ ⚠️ A model operating outside its declared plan is an unauthorized device. ☐ Cybersecurity — premarket documentation ☐ postmarket vulnerability management ☐

Part 10 — Promotion

☐ Every promotional claim maps to the cleared or approved intended use ☐ ☐ ⚠️ No off-label promotion — a physician's off-label use is the practice of medicine; the manufacturer's promotion makes the device misbranded under 21 U.S.C. § 352 and distribution a prohibited act under 21 U.S.C. § 331 ☐ ☐ Truthful scientific exchange distinguished from promotion, in writing, with a policy ☐ ☐ Wellness positioning audited — the line is crossed in a marketing meeting, in writing ☐ ☐ Performance claims substantiated — exposure under 15 U.S.C. § 45 and State consumer statutes ☐ ⚠️ This is the exposure for a device that worked exactly as designed and was oversold — and preemption does not touch it. ☐ Commercial organization trained ☐ Promotional materials reviewed before release ☐

Part 11 — Diagnostics and laboratories

☐ ⚠️ FIRST QUESTION: was the failure in the TEST or in the LABORATORY? The defendants, the standard of care, and the limitations period all differ, and a complaint against the wrong one loses time some jurisdictions do not return.

The laboratory — 42 U.S.C. § 263a, rules at 42 C.F.R. Part 493 ☐ Certificate obtained and current ☐ Type ______ ☐ Complexity level of the test performed ☐ waived ☐ moderate ☐ high ☐ ⚠️ Was the laboratory performing above its certificate level? ☐ If so, the violation predates any patient harm. ☐ Proficiency testing — enrolled in the correct specialties ☐ performance record obtained ☐ failures and corrective action ☐ ☐ Quality control and quality assessment records for the relevant period ☐ ☐ Patient test management — specimen collection ☐ handling ☐ identification ☐ result reporting ☐ critical value protocol ☐ ☐ Personnel qualifications — laboratory director ☐ technical supervisor ☐ testing personnel ☐ ☐ Biennial inspection and survey findings obtained ☐ ⚠️ Often available without discovery.

The test ☐ Was it a distributed kit cleared or approved as a device? ☐ Which pathway? ______ ☐ Or a laboratory developed test designed, made, and used in one laboratory? ☐ ⚠️ Whether such a test is a device is contested, and after Loper Bright Enterprises v. Raimondo a court resolves that statutory question rather than deferring to the agency. ☐ Planning advice either way: build the device-grade file — analytical and clinical validation ☐ design history ☐ complaint handling ☐ adverse event evaluation ☐ change control ☐ If the boundary moves, the evidence exists. If it does not, nothing was lost but effort.

Part 12 — Defending

☐ Raise preemption in the first responsive pleading for an approved device — 21 U.S.C. § 360k, Riegel v. Medtronic, Inc. ☐ attach the approval order and supplements ☐ ☐ Test the parallel claim for both defects at once — different-from-or-in-addition-to, and solely-because-of-federal-law ☐ A well-drafted motion shows the claim fails whichever way the plaintiff characterizes it, because the two escape routes are mutually exclusive. ☐ Learned intermediary record developed early — implanting physician's knowledge of failure rates from literature, colleagues, and experience ☐ would any further warning have changed the decision? ☐ ☐ Reporting record addressed proactively — submission log produced if complete ☐ gaps understood and explained before the plaintiff finds them ☐ ⚠️ A gap explained contemporaneously is a compliance issue. A gap discovered at deposition is a punitive damages exhibit. ☐ Alternative causation developed from treating records, not from experts ☐ ☐ Do not overreach — contesting a well-documented failure mode costs credibility on individual causation ☐ ☐ ⚠️ The mirror-image error: treating this as a science dispute when the decisive material is regulatory. Whoever knows the inspection history, complaint file, and CAPA record better controls the narrative — and all of it existed before the lawsuit did.

Part 13 — Ten failure modes

☐ Reasoning from injury severity to claim strength ☐ ☐ Pleading a parallel claim generically ☐ ☐ Pleading fraud on the agency ☐ ☐ ⚠️ Letting the explant go ☐ ☐ Ignoring the public databases before filing ☐ ☐ Treating a recall as proof of individual causation ☐ ☐ Confusing the test with the laboratory in a diagnostic case ☐ ☐ Choosing the notification pathway for speed without pricing the tort exposure ☐ ☐ Closing corrective actions without effectiveness verification ☐ ☐ Under-reporting adverse events ☐

Part 14 — Day-one intake script

Ask the client and the family these, in this order, at the first meeting.

☐ "What was implanted or used, and do you have any paperwork about it — a card, a sticker, a brochure?" ☐ "Which hospital, which surgeon, and what date?" ☐ "Has it been removed? When, where, and where is it now?" ⚠️ If it has not been removed yet, stop and send the preservation letters today. ☐ "Were you told anything about how often this device fails?" ☐ "Did anyone from the manufacturer contact you — a letter, a recall notice, a phone call?" ☐ "Have you had other surgeries, infections, or complications since?" ☐ "Who paid for the surgeries?" (this starts the lien inventory) ☐ "Have you signed anything, spoken with any lawyer, or joined any registry or settlement program?"

☐ Same day: order the operative reports and the implant sticker sheet, and send preservation letters to the hospital, surgeon, and manufacturer ☐ ☐ Same week: search the adverse event database and the recall list; pull the clearance or approval summary ☐ ☐ ⚠️ Do not evaluate the merits until the pathway is known and the explant is secured. Those two facts decide more than the medicine will.

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