Toolkit · Healthcare

The Device Classification, Recall Response, and Preemption Analysis Toolkit

21 U.S.C. § 360

Type
Toolkit
Jurisdiction
National
Date
2025-08-31
Topic
Healthcare

This toolkit supplies the working documents for a medical device matter. It opens with a pathway determination sheet and a predicate chain map, because those two pages decide whether an injury claim exists at all, followed by a preemption decision tree and a parallel claim pleading template with the specificity strict jurisdictions require. It provides an explant preservation letter and chain-of-custody form, an adverse event database search log, a recall matching worksheet that compares affected date ranges against the implant date, and a device timeline that isolates the interval between the first signal and the manufacturer's response. For the manufacturer side it includes an intended use statement worksheet, a quality system audit grid covering design controls and corrective action, a reporting decision log, and a promotional review checklist. A laboratory audit sheet and an authority reference sheet close it.

The Device Classification, Recall Response, and Preemption Analysis Toolkit

Healthcare > Medical Devices, Diagnostics, and Laboratory Testing | Published 31 August 2025 - Updated 15 July 2026 | UpLaw - uplaw.us

How to use this toolkit

Tools 1 through 4 decide whether an injury claim exists. Tools 5 through 8 build the evidence. Tools 9 through 12 are the manufacturer's file. Tool 13 is laboratories. Tool 14 is the authority.

⚠️ One orienting fact. Liability tracks the pathway, not the harm. The most rigorously reviewed devices are the hardest to sue over, which is why Tool 1 comes before any assessment of the medicine.

Tool 1 — Pathway determination sheet

Device ______ Manufacturer ______ Model ______ Product code ______ Unique device identifier ______ Lot ______ Serial ______ Implant date ______

Classification — ☐ Class I ☐ Class II ☐ Class III (criteria at 21 U.S.C. § 360c)

Pathway — ☐ Premarket notification (cleared) → Medtronic, Inc. v. Lohr: traditional State claims generally survive. (Registration and notification: 21 U.S.C. § 360, 21 C.F.R. Part 807.) ☐ Premarket approval → Riegel v. Medtronic, Inc.: design, warning, and strict liability claims preempted by 21 U.S.C. § 360k. (Approval: 21 U.S.C. § 360e, 21 C.F.R. Part 814.) ☐ Exempt Class I ☐ Risk-based classification of a novel device ☐ Investigational

Device or drug? Primary mode of action ______ ☐ chemical action or metabolism → drug (definition at 21 U.S.C. § 321) ☐ combination product, lead center ______

⚠️ Complete this before reading a single medical record.

Tool 2 — Predicate chain map

Generation Device / clearance Year Intended use as stated Technological change Later recalled?
Subject device
Predicate 1
Predicate 2
Predicate 3
Terminal predicate

☐ Terminal predicate precedes the modern framework? ☐ Yes ☐ No ☐ Intended use drift across generations ______ ☐ Any predicate later recalled ______ ⚠️ A recalled predicate does not automatically invalidate devices cleared against it — but it is a document, and it is public.

⚠️ Substantial equivalence is not a finding that the device is safe or effective. It is a comparison to something already sold. The chain, and the drift along it, is frequently where the case actually lives.

Tool 3 — Preemption decision tree

1. Was the device approved (PMA)? ☐ No, it was cleared → Lohr. Plead ordinary product claims. Stop here. ☐ Yes → continue.

2. Does the claim seek to impose a duty different from or in addition to a federal requirement? ☐ Yes → preempted under Riegel. Reframe or abandon. ☐ No → continue.

3. Does the claim exist SOLELY because federal law was violated? ☐ Yes → impliedly preempted under Buckman Co. v. Plaintiffs' Legal Committee. ☐ No → a parallel claim may proceed.

4. Which parallel shape? ☐ Manufacturing departure from approved specifications or from 21 C.F.R. Part 820 ☐ Failure to report under 21 U.S.C. § 360i / 21 C.F.R. Part 803, in a State recognizing a warning duty discharged through reporting ☐ Failure to satisfy a condition of approval, such as a postapproval study

5. Claims outside preemption entirely ☐ off-label promotion ☐ express warranty voluntarily made ☐ non-safety advertising under 15 U.S.C. § 45

⚠️ The two escape routes are mutually exclusive, which is what makes the parallel claim hard to plead and easy to attack. Draft it knowing the defense will argue both directions at once.

Tool 4 — Parallel claim pleading template

Use in every jurisdiction, including permissive ones. Specificity costs nothing and defeats the motion.

1. The federal requirement. "The device was approved under 21 U.S.C. § 360e. The approval order required ______. The quality system regulation at 21 C.F.R. Part 820, section ______, required ______."

2. The deviation. "Defendant departed from that requirement by ______, as documented in ______ [inspection observation, warning letter, recall notice, device history record]."

3. The State law duty. "State law independently imposes a duty to ______ [manufacture the product free of defects / warn of known risks], which parallels and does not exceed the federal requirement identified above."

4. Causation. "That deviation caused the device implanted in plaintiff on [date], lot ______, to ______, which caused ______."

5. The disclaimers. "Plaintiff does not seek to impose any requirement different from or in addition to federal requirements, and does not assert a claim for fraud on the agency."

⚠️ What defeats this motion is the exhibit, not the language. A warning letter naming the corrective-action subsection, dated before the implant, at the plant that made the lot, does more work than three pages of argument.

Tool 5 — Explant preservation letter and custody form

Letter — send to the hospital, the surgeon, the operating room, and the risk manager, before revision surgery where possible.

"Our client is scheduled for removal of [device, model, serial] on [date]. Please ensure that upon removal the device is: (1) retained by the facility and NOT returned to the manufacturer under any returned-goods program; (2) not cleaned, sterilized, reprocessed, or altered; (3) placed in a sealed, labeled container with the date, time, and name of the person removing it; (4) photographed before packaging; and (5) held pending a written testing protocol agreed among the parties. Please also preserve the operative reports, the implant log or sticker sheet, purchasing records identifying the lot, and any manufacturer representative's records relating to this procedure."

Chain of custody form

Date / time Item From To Container / seal no. Purpose Signature

☐ Photographs taken before handling ☐ device ☐ packaging ☐ labels ☐ all identifiers ☐ No destructive testing absent a written protocol with observation rights ☐

⚠️ A device case without the device is an argument about statistics. A device case with the device is an engineering case.

Tool 6 — Adverse event search log

Reporting duties at 21 U.S.C. § 360i, rules at 21 C.F.R. Part 803; corrections and removals at 21 C.F.R. Part 806.

Search term Date range Reports found Same failure mode? Earliest matching report
Device brand
Manufacturer
Product code
Model number

Earliest report of this failure mode ______ Client's implant date ______ Interval ______

☐ Reports compared against complaint volume produced in discovery — ratio ______ ⚠️ This ratio is the under-reporting case. ☐ Limits acknowledged — unverified ☐ duplicative ☐ incentive-driven ☐ no denominator, so no rate can be computed ☐ They establish notice. They do not establish frequency.

Tool 7 — Recall matching worksheet

Authority at 21 U.S.C. § 360h.

Recall number ______ Date initiated ______ Classification ☐ I ☐ II ☐ III Manufacturer's stated reason ______ Affected lots / serials ______ Affected date range ______ Client's lot / serial ______ Client's implant date ______

☐ Client's device inside the recall range? ☐ Yes ☐ No — then the complaint file for the interval before the recall is the discovery target ☐ Root cause stated as a manufacturing departure? ☐ ⚠️ If so, that is the factual predicate a parallel claim needs — the deviation is from the federal requirement itself. ☐ Was the recall voluntary or ordered? ______ ☐ Corrections and removals report filed under 21 C.F.R. Part 806? ______

⚠️ A recall proves knowledge and scope. It does not prove that this device injured this patient. Both sides overstate it in opposite directions.

Tool 8 — Device timeline

Event Date Source
Device cleared or approved summary
Earliest adverse event report, this failure mode database
Inspection observation public record
Warning letter public record
Client's implant operative report
Symptom onset medical records
Recall initiated recall notice
Revision or removal operative report

⚠️ The interval between the first signal and the manufacturer's response is the case. Everything else in this toolkit exists to fill in the two dates on either side of that gap.

Tool 9 — Intended use statement worksheet

Draft the sentence first. Everything else follows from it.

Intended use: "[Device] is intended for ______ in ______ patients, for the purpose of ______."

☐ Population ______ ☐ Condition ______ ☐ Setting ______ ☐ User ☐ clinician ☐ patient ☐ lay ☐ Mode of action ______ ⚠️ Chemical action or metabolism makes it a drug — 21 U.S.C. § 321. ☐ If software: does it analyze a signal, compute a diagnosis, or drive therapy? ☐ Yes → device ☐ No, it records, administers, displays, or supports general wellness → generally not ☐ Clinical decision support? — can a clinician independently review the basis, inputs, and logic? ☐ Yes → generally outside ☐ No → regulated ⚠️ The line turns on explicability, not accuracy. A highly accurate opaque model is on the regulated side. ☐ Every marketing claim mapped against this sentence ☐ Claims outside it removed ☐

Tool 10 — Quality system audit grid

21 C.F.R. Part 820

Element Evidence Gap Owner
Design and development plan
Design inputs (requirements)
Design outputs (specifications)
Design review, independent reviewer
Verification
Validation under actual or simulated use
Design transfer
Design change control
Risk analysis, with mitigations implemented and CLOSED
Design history file complete
Purchasing and supplier controls
Production and process controls
Nonconforming product handling
Complaint receipt, review, evaluation by designated unit
Reportability determination documented contemporaneously
CAPA: data analysis, investigation, action
⚠️ CAPA effectiveness verified before closure
Labeling and packaging control
Records and retention
Servicing records

⚠️ Two entries carry most of the litigation risk. A risk analysis naming the failure mode that later injures a patient, next to a deferred mitigation. And a corrective action closed without verifying it worked — a document proving the company found the problem and never confirmed the fix.

Adulteration follows from a nonconforming quality system under 21 U.S.C. § 351; misbranding from false or misleading labeling under 21 U.S.C. § 352; and distribution of either is a prohibited act under 21 U.S.C. § 331.

Tool 11 — Reporting decision log

Complaint no. Received Event described Death / serious injury / malfunction Reportable? Reasoning Reported on Days

☐ Manufacturer reports under 21 C.F.R. Part 803 ☐ importer obligations ☐ user facility obligations understood ☐ Corrections and removals evaluated under 21 C.F.R. Part 806 ☐ ☐ Recall decision procedure written before it is needed — 21 U.S.C. § 360h ☐ ☐ Postapproval study commitments tracked ☐ ☐ Adaptive software: predetermined change control plan on file ☐ model performance monitored against it ☐ ⚠️ A model operating outside its declared plan is an unauthorized device. ☐ Cybersecurity: premarket documentation ☐ postmarket vulnerability management ☐

⚠️ 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.

Tool 12 — Promotional review checklist

☐ Claim maps to the cleared or approved intended use ☐ Substantiation on file ☐ ☐ No promotion for uses outside the labeling ☐ ⚠️ 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. ☐ Truthful scientific exchange separated from promotion by written policy ☐ ☐ Comparative claims supported by head-to-head data ☐ ☐ Wellness language audited against the device definition ☐ ☐ Performance claims substantiated — exposure under 15 U.S.C. § 45 and State consumer statutes ☐ ⚠️ This is the exposure for a device that performed exactly as designed and was oversold. Preemption does not touch it. ☐ Sales training documented ☐ Representative conduct in the operating room addressed by policy ☐

Tool 13 — Laboratory audit sheet

42 U.S.C. § 263a; 42 C.F.R. Part 493

☐ ⚠️ First: was the failure in the TEST or in the LABORATORY? Different defendants, standard of care, and limitations period.

Item Finding
Certificate type and status
Complexity of the test performed ☐ waived ☐ moderate ☐ high
Performed above certificate level?
Proficiency testing enrollment and performance
Proficiency failures and corrective action
Quality control records, relevant period
Quality assessment program
Patient test management: collection, handling, identification, reporting
Critical value notification protocol
Laboratory director qualifications
Technical supervisor qualifications
Testing personnel qualifications
Biennial inspection / survey findings

☐ Laboratory developed test involved? ☐ ⚠️ Whether it is a device is contested, and after Loper Bright Enterprises v. Raimondo a court decides that statutory question rather than deferring to the agency. ☐ Device-grade file built anyway — analytical validation ☐ clinical validation ☐ design history ☐ complaint handling ☐ adverse event evaluation ☐ change control ☐

Tool 14 — Authority reference sheet

Definitions, classification, and pathways

Preemption

Postmarket obligations

Adulteration, misbranding, and promotion

Laboratories and agency scope

Tool 15 — Fast triage

☐ "The FDA approved it, so there's no case." → Tool 3. If it was cleared rather than approved, Lohr leaves the ordinary claims intact — and most devices are cleared. ☐ "The device is severe but it's a PMA product." → Tool 3, step 4, and Tool 4. Look for a manufacturing deviation or a reporting failure, and build it from public inspection records before filing. ☐ "Surgery is next week." → Tool 5, today. Everything else can wait; the explant cannot. ☐ "There's a recall." → Tool 7. Match the lot and date range first; if the implant predates the recall, the pre-recall complaint file is the target. ☐ "We're deciding between 510(k) and PMA." → Tool 1 and Tool 9, and price the tort exposure of the faster path before choosing it. ☐ "The lab missed a cancer." → Tool 13. Determine whether the failure was the test or the laboratory before naming anyone. ☐ "Our algorithm updates itself." → Tool 11. Confirm the change control plan exists and that the model is still inside it.

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