Medtronic, Inc. v. Lohr

Citations: 135 L. Ed. 2d 700; 116 S. Ct. 2240; 518 U.S. 470; 1996 U.S. LEXIS 4260Docket: 95-754

Court: Supreme Court of the United States; June 26, 1996; Federal Supreme Court; Federal Appellate Court

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The Medical Device Amendments of 1976 (MDA) classify medical devices based on risk, with Class III devices undergoing a strict premarket approval (PMA) process. However, many existing Class III devices, including Medtronic's pacemaker, have not completed PMA due to exceptions for pre-1976 devices and those substantially equivalent to them. The 510(k) process allows manufacturers to demonstrate substantial equivalence to avoid PMA. In a case involving a failure of a Medtronic pacemaker, the Lohr family asserted negligence and strict liability claims in state court, which Medtronic removed to federal court. The federal court dismissed the claims based on 21 U.S.C. 360k(a), which pre-empts state requirements differing from federal ones regarding device safety and effectiveness. The Court of Appeals partially reversed this decision, concluding that negligent design claims were not pre-empted, while negligent manufacturing and failure to warn claims were. The Supreme Court affirmed in part and reversed in part, holding that the MDA does not pre-empt the Lohrs' common-law claims. The Court emphasized that the FDA's substantial equivalence determination does not constitute a federally enforceable design requirement, and the 510(k) process does not focus on safety, allowing for state-law negligent design claims to proceed.

Section 360k(a) does not pre-empt state regulations that simply replicate FDA manufacturing practices and labeling rules. State requirements can be more stringent without being deemed different under 360k. The inclusion of a damages remedy does not constitute an additional requirement but reinforces compliance with existing federal laws. The FDA's regulations support this interpretation, emphasizing that pre-emption occurs only if a state requirement disrupts a specific federal interest.

The claims made by the Lohrs concerning manufacturing and labeling are not pre-empted, as the statutory language suggests that general federal requirements do not automatically pre-empt state requirements. State rules must pertain to medical devices and be distinct from federal requirements to be pre-empted, particularly if they relate to the safety or effectiveness of a device. Federal manufacturing and labeling requirements are general concerns that do not address specific devices, which Congress intended to protect from conflicting state requirements.

Florida's common-law requirements do not specifically address medical devices and thus are not the type of requirements Congress aimed to shield from state interference. Justice Stevens, joined by Justices Kennedy, Souter, and Ginsburg, found Medtronic's argument that common-law actions constitute a requirement under 360k(a) implausible, as it would grant the entire industry immunity from design defect liability contrary to Congress's intent for stricter regulation.

Justice Breyer also concluded that while the MDA may pre-empt some state tort suits, it does not pre-empt the claims at hand. The MDA's pre-emption provision is ambiguous, indicating that courts should seek guidance on which federal requirements pre-empt state ones. The FDA's regulations suggest that the agency does not view its requirements as pre-emptive over the state claims in question. Additionally, general principles of conflict and field pre-emption support the argument that the plaintiffs' tort claims are not pre-empted.

Justice Stevens delivered the Court's judgment and opinion regarding Parts I, II, III, V, and VII, joined by Justices Kennedy, Souter, Ginsburg, and Breyer. He also provided an opinion for Parts IV and VI, joined by Justices Kennedy, Souter, and Ginsburg. Chief Justice Rehnquist and Justices O'Connor, Scalia, and Thomas partially joined Stevens’ opinion. Justice Breyer filed a concurring opinion, while Justice O'Connor filed a partial concurrence and dissent, joined by Rehnquist, Scalia, and Thomas.

The case revolves around the Medical Device Amendments of 1976, aimed at ensuring the safety and effectiveness of medical devices for human use. The primary legal question is whether this federal statute pre-empts a state common-law negligence claim against Medtronic, Inc. for an allegedly defective pacemaker that failed and injured Lora Lohr.

Historically, states have exercised their police powers to safeguard public health and safety, indicating a strong local interest in such matters. However, in recent decades, the federal government has taken a more active role in public health protection, starting with the Food and Drug Act of 1906. The 1938 Federal Food, Drug, and Cosmetic Act expanded regulations to include medical devices, reflecting growing concerns over their safety and efficacy. The legislative history shows an increasing acknowledgment of the risks associated with medical devices as technology advanced, leading to significant legislative efforts to regulate their introduction and use.

In 1970, the Dalkon Shield, an intrauterine contraceptive device, was marketed as a safe contraceptive but led to numerous unintended pregnancies, serious infections, and some fatalities. This prompted consumer and regulatory scrutiny of various medical devices, including catheters and pacemakers, leading to the enactment of the Medical Device Amendments of 1976 (MDA). The MDA categorizes medical devices into three classes based on their risk to public health: Class I devices are minimally regulated; Class II devices must meet federal performance standards; and Class III devices, which pose significant risks, require manufacturers to demonstrate safety and efficacy through a rigorous premarket approval (PMA) process. Pacemakers are classified as Class III devices, necessitating that manufacturers submit extensive safety and efficacy data to the FDA, which spends approximately 1,200 hours reviewing each submission. Notably, not all Class III devices have undergone PMA due to two exceptions: a grandfathering provision allows devices marketed before 1976 to remain available without approval, and devices deemed substantially equivalent to existing ones can bypass the PMA process.

Substantially equivalent Class III medical devices can be marketed without the stringent premarket approval (PMA) review, unlike new Class I and Class II devices, which are subject to the 510(k) premarket notification process. This process requires manufacturers to submit a notification to the FDA, which evaluates whether the new device is substantially equivalent to an existing one. If so, the device can enter the market without further regulatory scrutiny, although this is contingent upon the FDA's future PMA process for the original device. The 510(k) process is significantly less time-consuming than PMA, averaging about 20 hours compared to the 1,200 hours needed for PMA reviews. The 510(k) process is attractive to manufacturers due to its minimal information requirements, rapid processing, and low incidence of negative responses from the FDA. Over the years, a substantial majority of Class III devices have been approved via the 510(k) process rather than PMA; for example, a 1990 report indicated that 80% of new Class III devices were introduced without PMA review. Medtronic utilized this expedited 510(k) process in 1982 to market its Model 4011 pacemaker lead, which the FDA deemed substantially equivalent to existing devices, allowing its market entry while clarifying that this determination did not imply safety endorsement.

Lora Lohr relies on a Medtronic pacemaker, implanted in 1987, which failed in 1990, leading to a heart block and emergency surgery. Lohr and her husband filed a complaint in Florida state court in 1993, alleging negligence and strict liability against Medtronic. The negligence claim contended that Medtronic breached its duty to ensure the pacemaker's safety and to warn about potential failures, while the strict liability claim asserted that the device was defectively designed and dangerous upon sale. A breach of warranty claim was dismissed. Medtronic removed the case to federal court, arguing that the claims were pre-empted by 21 U.S.C. § 360k(a), which prohibits state requirements differing from federal standards for medical devices. The District Court initially denied Medtronic’s motion but later reversed its decision after the Eleventh Circuit ruled that some common-law claims are pre-empted under § 360k(a). The appellate court determined that state common law constitutes state requirements and that negligence claims cannot evade pre-emption by citing violations of federal standards. However, it found that the negligent design claims were not pre-empted, indicating that federal requirements must be specific to a device to pre-empt state claims. The court rejected Medtronic's arguments regarding the FDA's assessment of the pacemaker's safety and ongoing surveillance as sufficient federal requirements.

Negligent manufacturing and failure to warn claims were deemed pre-empted by the FDA's good manufacturing practices and labeling regulations, which set forth requirements for medical device manufacture and warnings. The court held that while strict liability claims based on unreasonably dangerous design were not pre-empted, negligent manufacturing and failure to warn claims could not be pursued under strict liability. Medtronic sought review of the appellate court's affirmation of the district court's ruling, while the Lohrs cross-petitioned regarding the upholding of the pre-emption defense. The Supreme Court granted both petitions due to a split among appellate courts on the pre-emption of state common-law claims under the Medical Device Amendments (MDA). The Court emphasized the need to interpret the statute's pre-emptive language while considering historical state police powers and Congress's intent, adhering to a presumption against pre-emption in traditionally state-regulated areas. The analysis also highlighted that Congress’s purpose is central to determining pre-emption scope.

Understanding the scope of a pre-emption statute hinges on discerning congressional intent, primarily from the statute's language and its broader statutory context. The structure and purpose of the statute also inform this understanding, which impacts businesses, consumers, and legal frameworks. Medtronic asserts that the Court of Appeals incorrectly found that the Lohrs' claims of negligent design were not pre-empted by 21 U.S.C. 360k(a). This statute prohibits states from imposing any requirements differing from those established at the federal level concerning medical devices, particularly regarding safety and effectiveness. Medtronic argues that any common-law claims represent additional requirements that conflict with federal standards imposed by the FDA under the Medical Device Amendments (MDA). However, this argument is considered implausible, as it would effectively eliminate state consumer protections against defective medical devices and deny judicial recourse for injured parties. The absence of an explicit private cause of action in the MDA further undermines Medtronic's position, suggesting Congress did not intend to provide manufacturers with complete immunity from design defect liability. The interpretation that 360k entirely pre-empts common-law claims would imply a significant and unlikely withdrawal of judicial remedies for injuries caused by unlawful conduct. Lastly, the language of the statute suggests an expectation that states may impose specific duties on manufacturers, indicating that the statute does not broadly pre-empt common-law claims as Medtronic contends.

The pre-emption statute in Cipollone was specifically aimed at certain state requirements related to smoking and health, particularly concerning the advertising of cigarettes that comply with federal labeling laws. The Court determined that the petitioner could pursue some common-law claims that did not conflict with the pre-emption statute. In contrast, Medtronic's broad interpretation of the statute would significantly impede state legal remedies and infringe on state sovereignty, potentially eliminating remedies for the Lohrs’ injuries. The ambiguity of the statute suggests that Congress did not intend to restrict states from protecting consumers from medical device dangers. Unlike Cipollone, which focused on specific state statutes, the Medical Device Amendments (MDA) repeatedly reference requirements related to state-enacted positive law, not general common law. The FDA is also granted the authority to exclude certain requirements from pre-emption, and no exemptions resemble common-law claims. The MDA’s primary purpose was to ensure the safety and effectiveness of medical devices, not to protect device innovation from common-law claims. Legislative history indicates concerns were more about avoiding redundant regulations rather than fears of product liability hindering device development. Ultimately, concerns for consumer safety outweighed any industry protection measures reflected in the Act.

Legislative history indicates that section 360(k) was not designed to pre-empt general common-law duties enforced through damages actions against manufacturers and distributors of defective medical devices. There is no evidence in legislative discussions suggesting a broad intention to eliminate traditional common-law remedies, especially given Congress's awareness of ongoing product liability litigation. This ambiguity implies that some common-law claims against medical device manufacturers may still proceed post-enactment of the Medical Device Amendments (MDA).

In this case, Medtronic presents arguments for the pre-emption of the Lohrs' claims, while the Lohrs contend that their entire complaint should survive scrutiny regarding 360(k)'s pre-emptive scope. The Lohrs assert that their negligent design claims are not pre-empted since the 510(k) premarket notification process does not impose specific design requirements on Medtronic's pacemaker. They argue that even if federal regulations on manufacturing and labeling impose requirements that pre-empt state laws, 360(k) does not extend to state rules that merely duplicate federal standards. Furthermore, they maintain that state laws imposing common-law duties do not conflict with federal manufacturing and labeling regulations, thereby avoiding pre-emption.

The Court of Appeals determined that the Lohrs' defective design claims were not pre-empted because the federal requirements were not sufficiently concrete to constitute pre-emptive authority. Medtronic counters this by referencing the FDA's determination of substantial equivalence for Model 4011 to an earlier device and its authority to withdraw the device from the market if its design is altered. However, the court highlighted that the 510(k) process focuses on equivalence rather than safety, which provides limited public protection, and that the design of Model 4011, like other substantially equivalent devices, has not undergone formal safety or efficacy review under the MDA. The FDA's letter to Medtronic clarified that it required compliance with general standards, the lowest protection level, and explicitly stated that it did not constitute FDA approval of the device.

Misleading representations implying official FDA approval based on compliance with premarket notification regulations constitute misbranding. The FDA's examination of 510(k) applications for Class III devices, including Medtronic's pacemaker, does not mandate a specific form or process; rather, it allows marketing without the premarket approval (PMA) process due to the device's substantial equivalence to pre-1976 models. Congress intended this to enable limited competition among manufacturers of existing devices. The substantial equivalence exemption was designed to maintain the status quo regarding marketing and does not absolve manufacturers from defending against state-law claims of negligent design. The Court of Appeals found that Congress's intent is crucial in pre-emption cases, confirming that the substantial equivalence provision does not pre-empt the Lohrs' design claims. The Lohrs argue that state requirements related to manufacturing and labeling are not pre-empted if they align with federal regulations. They assert that their claims could include violations of FDA regulations, which can coexist with state law without resulting in pre-emption. Florida law allows for a damages remedy for violations of common law duties that parallel federal requirements, and any additional state-law elements, like proving negligence, do not broaden state requirements but rather narrow them compared to federal standards. Thus, the presence of a damages remedy does not constitute an additional requirement that would trigger pre-emption.

FDA regulations clarify the scope of pre-emption under 360k, supporting the Lohrs' interpretation. The inconsistent views of various Courts of Appeals indicate ambiguity in the language of 360k. Congress has assigned the FDA a significant role in defining the pre-emptive effect of this statute, which does not automatically pre-empt state laws but does so only when the FDA has issued relevant federal requirements. The FDA is tasked with evaluating whether state laws obstruct the objectives of Congress, a duty reinforced by the authority to exempt certain state regulations from pre-emption. FDA regulations allow states or individuals to seek advisory opinions on whether specific state requirements are pre-empted, as indicated in 21 CFR 808.5 (1995). The uncertainty in the statute and the FDA's delegated authority lend substantial weight to the agency's interpretation. The FDA's rules suggest that 360k does not pre-empt state or local laws that are equivalent to federal requirements. At this stage, the Court of Appeals should not have dismissed the Lohrs' claims regarding manufacturing and labeling based on pre-emption, particularly as these claims allege non-compliance with federal standards. The Court of Appeals viewed these claims as conflicting with federal regulations governing medical device labeling and manufacturing, which include strict labeling requirements and adherence to Good Manufacturing Practices (GMPs).

The excerpt outlines the legal framework regarding the pre-emption of state law by federal law in the context of medical devices as governed by the FDA. It highlights that the FDA enforces general requirements against manufacturers, but these requirements do not necessarily pre-empt state claims unless they specifically conflict with state regulations applicable to the same device. The Lohrs argue that since federal requirements are general and cover various devices, they do not meet the pre-emption threshold outlined in 21 U.S.C. § 360k(a)(1), which necessitates that a federal requirement must be applicable to the specific device in question. Furthermore, they assert that general state laws related to other products or unfair trade practices are not pre-empted by federal regulations, which only apply when specific counterpart regulations for a device exist. The FDA's regulations clarify that state requirements related to the safety or effectiveness of a device are only pre-empted if they create substantive requirements for that specific device. The excerpt also notes that the FDA has not granted exemptions for state laws of general applicability, with existing exemptions solely applying to particular state regulations concerning hearing aids. Overall, the text emphasizes that pre-emption is limited to specific conflicts between state and federal requirements concerning medical devices, reinforcing the necessity for state requirements to be distinct and relevant to the devices in question.

The statute and regulations necessitate a thorough comparison between federal requirements and state requirements to assess whether state claims are pre-empted. In this instance, the Lohrs' common-law claims are deemed not pre-empted by federal labeling and manufacturing requirements due to their general nature, which contrasts with cases where the federal government has made specific, unambiguous mandates for particular devices. The federal regulations reflect broad concerns about device regulation rather than specific issues related to individual devices, which Congress and the FDA aimed to protect from conflicting state laws. Additionally, the state common-law obligations in this case are also general and not tailored to medical devices, thus not posing a threat to federal regulations. The legal basis for the Lohrs' claims stems from general manufacturer duties to ensure product safety and to warn users of potential dangers, which do not conflict with federal requirements. These claims are not pre-empted by the Medical Device Amendments (MDA) as they fall outside the intended scope of pre-emption. The Lohrs' argument that common-law duties should never be considered requirements under 360k is noted but not addressed, as the current case does not involve pre-emption, making future hypothetical scenarios unnecessary for resolution.

The excerpt emphasizes the significance of device-specificity in the context of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act, suggesting that few common-law duties are pre-empted by the statute. It notes that courts are unlikely to impose substantive requirements for specific devices, and it remains unnecessary to determine explicit pre-emption unless a relevant case arises. The judgment of the Court of Appeals is reversed regarding the pre-emption of claims while affirming the rejection of the pre-emption defense, with the case remanded for further proceedings.

Justice Breyer concurs, addressing two questions: whether the MDA pre-empts state law tort actions and, if so, whether it pre-empts the specific claims in this case. He agrees that the MDA can pre-empt state tort suits, interpreting the statute's language to include state legal requirements arising from tort law. He references prior Supreme Court cases that support this interpretation, indicating that state regulation can manifest through damage awards. Breyer warns against a contradictory ruling that would allow a state jury to impose standards differing from federal regulations, suggesting that such an outcome would contradict congressional intent to maintain uniformity in federal standards.

The MDA pre-empts state requirements if they conflict with federal standards, including those arising from tort actions based on state law. However, Congress has not explicitly stated its intent regarding the pre-emption of specific tort claims related to the MDA. The pre-emption provision is ambiguous, indicating that while federal requirements may override state ones, it does not clarify the conditions or scope of this pre-emption. The court must consider which federal requirements apply to state laws and how they interact, rather than assuming that a single federal rule precludes all related state regulations. Additionally, the court has suggested that, in the absence of clear congressional direction, administrative agencies, such as the FDA, have the discretion to determine which regulations carry pre-emptive effect. The FDA is tasked with overseeing the MDA and can interpret the implications of both federal and state requirements, signaling its pre-emptive intentions through various communications, including regulations and statements. The FDA also holds the power to exempt certain state laws from pre-emption, necessitating an evaluation of how federal laws affect state requirements.

The FDA has established a regulation indicating that state requirements are preempted only when there are specific federal requirements for a device that diverge from or add to state laws (21 CFR 808.1(d)). The term "divergent" does not clarify when federal and state requirements are closely related enough to warrant preemption analysis. However, the term "specific" narrows the range of federal requirements the FDA intends to displace state law. The FDA's existing requirements, although numerous, are not considered specific enough to preempt state requirements in this context. Justice O'Connor's description of federal standards as comprehensive does not imply an intent to fully preempt state laws, as the court has historically refrained from such inferences based solely on the comprehensiveness of federal regulations. The FDA's preemption-related regulation suggests intent to allow states to enact their own laws.

Furthermore, principles of conflict and field preemption indicate that federal requirements preempt state requirements if (1) compliance with both is impossible or (2) the state law obstructs the objectives of federal law, or if (3) federal regulation is so comprehensive that it implies a lack of space for state laws. Absent contrary congressional or agency intent, the preemption statute and regulation should be interpreted through these principles, as the terms "different from" and "in addition to" align with foundational preemption concerns. The regulation's term "divergent" should also be interpreted in light of these preemption principles.

The analysis concludes that there is no preemption of state law tort claims by federal regulations concerning medical devices. The court found no conflict between federal requirements and the liability principles underlying the plaintiffs' state law claims. The opinion emphasizes that neither Congress nor the FDA intended to fully occupy the relevant regulatory field, supporting the court's judgment. Justice O'Connor, joined by other justices, concurs in part and dissents in part, arguing that state common-law claims do impose requirements that can be preempted under the Medical Device Amendments (MDA) of 1976. She critiques the majority opinion for not adequately interpreting the statutory language of section 360k(a), which prohibits states from establishing requirements that differ from federal standards. O'Connor references a prior case, Cipollone, to support her view that common-law damages actions do impose requirements, asserting that the majority's interpretation lacks clarity and consistency. The discussion highlights a need to analyze whether state common-law actions can be deemed requirements under the MDA, as the court evaluates the implications of the Lohrs' claims against Medtronic's device.

The phrase "no requirement or prohibition" is interpreted broadly to encompass obligations that arise from common law, suggesting no distinction between statutory requirements and common-law rules. State regulation can effectively be enforced through damage awards as well as preventive relief, with compensation serving as a significant mechanism for influencing conduct and policy. This rationale applies equally to state common-law actions related to product labeling and manufacturing, which compel manufacturers to adhere to common-law duties. The reasoning in Cipollone supports the view that common-law actions impose requirements consistent with statutory language and understanding.

The text argues that if the language of the statute is taken literally, it pre-empts state common-law actions imposing different or additional requirements than those under the Federal Food, Drug, and Cosmetic Act (FDCA), akin to how it would pre-empt conflicting state statutes or regulations. Justice Breyer concurs with this interpretation. The plurality opinion attempts to dispute this reading, claiming Congress did not intend for "requirement" to encompass state common-law claims. Nevertheless, it acknowledges that state common-law actions could represent a requirement, although such cases would be uncommon.

The Court rules that FDCA requirements trigger pre-emption only when a specific conflict exists between state and FDCA requirements for a particular device, but it does not exclude the possibility of general federal or state requirements affecting pre-emption. The plurality emphasizes the need for specificity in understanding the pre-emption framework. To support its interpretation, the Court references FDA regulations, although it stops short of acknowledging deference to these regulations, suggesting uncertainty about their authority in determining pre-emption effects.

An express pre-emption clause in a statute directs that the initial interpretation should focus on the clause's clear language, which reflects Congress' intent regarding pre-emption. If the statute's language is unambiguous, deference to an agency's interpretation is inappropriate. Specifically, Title 21 U.S.C. 360k(a)(1) pre-empts any state requirements that differ from or add to federal requirements under the Federal Food, Drug, and Cosmetic Act (FDCA). The term "requirement" includes state common-law claims. The court incorrectly applies an agency's restrictive interpretation of the statute where such deference is unwarranted.

A thorough reading of 360k indicates that state common-law claims are pre-empted if they impose any requirement different from or in addition to FDCA standards. The analysis then shifts to whether existing FDCA requirements can pre-empt the Lohrs' state-law claims. The court agrees that the Lohrs' defective design claim is not pre-empted by the FDCA's 510(k) process, which only assesses substantial equivalence to devices pre-dating 1976 and does not impose specific requirements on devices.

The court also concurs that the Lohrs' claims are valid when enforcing federal requirements, since such claims do not introduce different or additional requirements beyond federal law. Section 360k allows states to impose different remedies but not additional requirements. However, there is disagreement with the court's view that the Lohrs' claims compel Medtronic to comply with different FDCA requirements. The author contends that many of the Lohrs' common-law claims regarding manufacturing and labeling would indeed require Medtronic to meet standards beyond those established by the FDA, specifically referencing comprehensive FDA Good Manufacturing Practice (GMP) regulations.

Lohr's common-law claims related to manufacturing are pre-empted because they would create state requirements that differ from or add to federal Good Manufacturing Practice (GMP) standards. Similarly, their failure-to-warn claim is pre-empted by FDA labeling requirements outlined in 21 CFR 801.109, which mandates comprehensive information on device labels, including indications, effects, and precautions. The statutory language of Section 360k(a) indicates that any state common-law claim imposing additional requirements beyond federal standards is pre-empted. The judgment of the Court of Appeals is affirmed regarding the non-pre-emption of Lohr's design claim, while the manufacturing and failure-to-warn claims are pre-empted. The opinion also notes that the FDA has not initiated a Premarket Approval (PMA) process for certain devices, although there are indications of potential future reclassification. The 1990 amendments to the Medical Device Amendments (MDA) aimed to reduce reliance on the 510(k) process while ensuring rigorous review for higher-risk devices. Furthermore, Section 360k(b) allows the FDA to exempt state requirements from pre-emption if they are more stringent or necessary due to local conditions, provided they do not conflict with federal standards.

The FDA has established regulations under the statute 360k(a), which delineate its pre-emptive authority and the conditions under which exemptions may be granted. This authority, originally vested in the Secretary of Health and Human Services, has been delegated to the FDA. The Secretary also has the power to exempt state requirements. The FDA's authority to enforce recalls or refunds for defective devices primarily benefits manufacturers rather than injured plaintiffs, as it does not provide a means for private recovery of damages and is seldom used.

The excerpt references important cases regarding the pre-emptive effects of the 510(k) process. For instance, in *English v. Mentor Corp.* and *Feldt v. Mentor Corp.*, courts interpreted the 510(k) process's role in creating potential pre-emptive requirements. It notes the complexity of claims under 360k(a), stating that some common-law claims may not be covered, as seen in *Kennedy v. Collagen Corp.*.

Additionally, it discusses the historical context of pre-emption statutes, particularly the distinction between the earlier 1965 law and the 1969 Public Health Cigarette Smoking Act. While the latter provided clearer federal pre-emption without needing agency regulations, the Medical Device Amendments (MDA) require FDA interpretation for specifics. This context underscores the FDA's crucial role in implementing the provisions of 360k. Lastly, it highlights that there are 22 exemptions under 21 CFR 808.53-808.101 (1995), specifically related to state regulations concerning the sale of hearing aids.

Special statutory exemptions allow the FDA to permit the use of investigative and experimental devices in commerce without requiring premarket approval (PMA) or demonstrating substantial equivalence, as outlined in 21 U.S.C. 360j(g) and 21 CFR pt. 813 (1995). The existence of a pre-emption statute indicates concerns that state regulations could disrupt the medical device market. If Congress intended the Medical Device Amendments (MDA) to significantly alter state-law remedies, one would expect references to such changes in legislative reviews, which are notably absent in contemporary discussions and hearings. The FDA's 1982 commentary referred to the 510(k) provision as a pro-competition mechanism, allowing quick market entry for "me-too" devices, indicating that devices on the market prior to the amendments should not monopolize the market. Additionally, the FDA allows manufacturers with premarket approval to make certain safety-enhancing changes without prior approval. Good Manufacturing Practices (GMPs) require quality assurance programs, organizational structure, personnel hygiene, and adequate facilities to ensure product safety. The FDA’s interpretation of 21 U.S.C. 360k(a) reflects a limited understanding of the regulation's scope.

State or local regulations are preempted by federal law only when the FDA has specific counterpart regulations for a device or when additional requirements under the act create a conflict. Certain state or local regulations are not preempted under section 521 (a) of the act if they do not apply specifically to devices. Examples of non-preempted requirements include: 

1. General applicability requirements that relate to multiple products (e.g., electrical codes, warranty laws) or unfair trade practices not limited to devices.
2. State or local requirements that are identical or substantially similar to federal requirements.
3. General enforcement provisions, such as state inspections of factory records for all devices.
4. Prohibitions against manufacturing adulterated or misbranded devices, unless they create specific substantive requirements (e.g., labeling).

Additionally, the court's analysis in Cipollone regarding the Public Health Cigarette Smoking Act indicates that general obligations, such as the duty not to deceive, are not preempted by specific federal statutes. The preemption analysis under the Medical Device Amendments (MDA) demands a more thorough examination of the relationship between federal and state requirements compared to the Cipollone case.