FDA preemption means federal law can block some state-law injury claims over medical devices. For devices that received FDA premarket approval, many claims challenging safety or effectiveness are preempted. For devices cleared through the 510(k) process, the U.S. Supreme Court has allowed certain state claims to proceed.
That means how a device reached the market can shape a Nevada patient’s claim. This guide explains the difference, what patients can check, and which deadlines may apply. It is not medical guidance, so talk with your healthcare provider about any concerns with a device.
Key Takeaways
- 21 U.S.C. § 360k(a) limits state requirements that differ from or add to federal device requirements.
- Riegel v. Medtronic held that common-law claims challenging a premarket-approved device’s safety or effectiveness are barred.
- Medtronic v. Lohr held that certain claims about a 510(k) device were not preempted.
- A device recall can matter, but it does not prove a claim by itself.
- Nevada generally allows 2 years to sue for personal injury, and when that period begins can be disputed.
What Is FDA Preemption for Medical Devices?
Under 21 U.S.C. § 360k(a), a state may not establish or continue any requirement for a device that is different from, or in addition to, a federal requirement and that relates to the device’s safety or effectiveness or to another matter included in a federal requirement. Courts have applied this language to some state-law injury claims.
How Does the Device’s FDA Pathway Affect a Claim?
| Pathway | Key case | Effect on state claims |
|---|---|---|
| Premarket approval | Riegel v. Medtronic, Inc. | Common-law claims challenging the safety or effectiveness of a medical device are generally preempted when the device received FDA premarket approval. :chatgpt-content-reference{index=”0″} |
| 510(k) substantial equivalence | Medtronic, Inc. v. Lohr | The Court held that the state-law claims at issue, including negligent design, manufacturing, and labeling claims, were not preempted under the 510(k) pathway. :chatgpt-content-reference{index=”1″} |
In Riegel, the syllabus explains that premarket approval imposes specific requirements. In Lohr, the syllabus explains that the 510(k) process is focused on equivalence, not safety. Which pathway applied to your device can be an early and important question.
Does Preemption End Every Claim?
No. Preemption depends on the device and the type of claim. Riegel involved claims challenging a premarket-approved device’s safety or effectiveness. Claims that a company violated federal requirements, often called parallel claims, raise separate questions, and the Court’s syllabus says it did not decide whether the suit there raised them. A lawyer can explain how these rules apply.
How Can You Find Out About Your Device?
- Device details. Your medical records or implant card may list the maker, model, and lot number.
- FDA reports. The MAUDE database contains reports of device problems.
- Recalls. The FDA publishes information on device recalls and corrections.
- Problem reports. The FDA encourages patients to report device problems through MedWatch.
What Does a Device Recall Mean?
The FDA describes recalls as actions taken by a firm to remove a product from the market, and its device pages also refer to corrections. It classifies them by risk. Class I covers a reasonable probability of serious adverse health consequences or death, Class II covers temporary or medically reversible effects or a remote chance of serious harm, and Class III covers products unlikely to cause adverse health consequences.
A recall can help show a problem, but it does not prove the device caused your injury.
What Happens if a Device Is Removed?
If a device is removed, it can become key evidence. A patient may ask the hospital in advance about keeping it, or about how it will be stored. A lawyer can explain how to request preservation before the device is lost or discarded.
How Does Nevada Law Apply?
Nevada recognizes strict liability for defective products. In Ford Motor Co. v. Trejo, the Nevada Supreme Court applied the consumer-expectation test to a design defect claim. Whether a state-law claim about a device can proceed may depend on federal preemption first. See our Nevada defective products page.
A claim may also involve a doctor or hospital, which can bring separate rules under NRS Chapter 41A.
How Long Do You Have to File?
Under NRS 11.190(4)(e), Nevada generally allows 2 years to sue for injuries caused by the wrongful act or neglect of another. Under Nevada’s discovery rule, discussed in Adkins v. Union Pacific Railroad Co., the period generally does not begin until a person knew, or reasonably should have known, of facts giving rise to the injury. With implants, that date can be disputed. A lawyer can explain how it applies.
Talk With a Nevada Defective Product Lawyer
Vaksman Khalfin, PC handles Nevada defective product claims and has an office in Las Vegas. A lawyer can review your situation and explain the options that may be available. Contact us or visit our Nevada defective products page to learn more.
General information, not legal advice. This page is provided for general informational purposes only and is not medical advice. No attorney-client relationship is formed by reading this page or contacting the firm. Prior results do not guarantee a similar outcome.
Reviewed by Robert B. Vaksman, Partner, Vaksman Khalfin, PC (admitted in Nevada). Last reviewed: 11/05/2026
Frequently Asked Questions
You may be able to, but federal preemption can limit some claims. The answer often depends on how the FDA reviewed the device and what the claim says. A lawyer can explain your options.
Premarket approval involves specific FDA requirements for a device. The 510(k) process focuses on whether a device is substantially equivalent to an existing one. The U.S. Supreme Court has treated claims differently under each.
Start with the maker and model from your medical records or implant card. A lawyer can review FDA records to confirm how the device reached the market.
No. A recall is not required, and a recall does not by itself prove your injury was caused by a defect. You would still need evidence of defect and causation.
