`United States Court of Appeals
`FOR THE DISTRICT OF COLUMBIA CIRCUIT
`
`
`
`
`Argued April 23, 2021
`
`
`Decided July 6, 2021
`
`No. 20-1087
`
`THE JUDGE ROTENBERG EDUCATIONAL CENTER, INC.,
`PETITIONER
`
`v.
`
`UNITED STATES FOOD AND DRUG ADMINISTRATION, ET AL.,
`RESPONDENTS
`
`
`
`
`Consolidated with 20-1088
`
`
`
`On Petitions for Review of an Order
`of the Food & Drug Administration
`
`
`
` Max D. Stern argued the cause for petitioners Luis Aponte,
`et al. With him on the briefs were Joseph M. Cacace, and
`Alexandra H. Deal.
`
` Michael P. Flammia argued the cause for petitioner The
`Judge Rotenberg Educational Center, Inc. With him on the
`
`
`
`

`

`2
`
`briefs were Christian B. W. Stephens, Matthew D. Rodgers,
`Edward J. Longosz, II, and Jeffrey N. Gibbs.
`
`Richard A. Samp was on the brief for amicus curiae The
`
`New Civil Liberties Alliance in support of petitioners.
`
`Daniel Aguilar, Attorney, U.S. Department of Justice,
`
`argued the cause for respondents. With him on the brief were
`Sarah E. Harrington, Deputy Assistant Attorney General, and
`Scott R. Mcintosh, Attorney.
`
`Felicia H. Ellsworth was on the brief for amici curiae
`
`American Academy of Pediatrics, et al. in support of
`respondents.
`
`Before: SRINIVASAN, Chief Judge, KATSAS, Circuit Judge,
`
`and SENTELLE, Senior Circuit Judge.
`
`Opinion for the Court filed by Senior Circuit Judge
`
`SENTELLE.
`
`
`
`
`Dissenting opinion filed by Chief Judge SRINIVASAN.
`
`SENTELLE, Senior Circuit Judge: The Judge Rotenberg
`Educational Center and the parents and guardians of its patients
`both petition for review of a Food and Drug Administration
`(FDA) rule banning electrical stimulation devices used to treat
`aggressive or self-injurious behavior. In its rule, the FDA
`determined that the devices present an unreasonable and
`substantial risk of illness or injury, but only when used to treat
`aggressive or self-injurious behaviors. The petitioners contend
`that banning a medical device for a particular purpose regulates
`the practice of medicine in violation of 21 U.S.C. § 396. We
`agree, grant the petitions for review, and vacate the FDA’s rule.
`
`
`
`
`

`

`
`
`
`3
`
`I.
`
`Background
`
`
`A. Factual background
`
`
`The Judge Rotenberg Educational Center is a facility in
`Massachusetts
`that
`treats patients with severe mental
`disabilities. The Center admits patients that other facilities
`could not successfully treat. According to the Center, some of
`its patients suffer from severe self-injurious and aggressive
`behaviors that are difficult or impossible to treat using
`conventional behavioral and pharmacological techniques. The
`most common self-injurious behaviors include head-banging
`and self-biting. The behaviors of some patients are extreme
`enough that they have suffered self-inflicted brain trauma,
`broken and protruding bones, and blindness.
`
`Before the ban at issue in this case, the Center treated some
`of its patients exhibiting severe self-injurious or aggressive
`behavior with an electrical stimulation device. The device,
`called a graduated electronic decelerator, briefly shocks
`patients causing them to reduce or cease their self-injurious
`behaviors. Banned Devices; Electrical Stimulation Devices for
`Self-Injurious or Aggressive Behavior, 85 Fed. Reg. 13,312,
`13,314 (March 6, 2020). The Center is the only facility in the
`country that uses electric shock therapy to treat individuals who
`severely self-injure or are aggressive. Other health care
`practitioners not affiliated with
`the Center, however,
`administer electrical stimulation devices to treat a wide variety
`of other conditions, including tobacco, alcohol, and drug
`addictions, as well as inappropriate sexual behaviors following
`traumatic brain injuries. Id. at 13,317. The Center manufactures
`its own devices. The Center treats approximately 20% of its
`patients with this treatment at any given time.
`
`
`
`

`

`4
`
`
`The devices are subject to extensive federal and state
`regulation. The FDA regulates aversive conditioning devices,
`including ones that use electrical shocks, as Class II devices.
`21 C.F.R. § 882.5235. That classification includes all medical
`devices that the FDA determines are reasonably safe and
`effective when subject to special controls like postmarket
`surveillance and patient registries. 21 U.S.C. § 360c(a)(1)(B).
`In addition to the federal regulation, Massachusetts requires
`several entities to approve electrical shock treatment. See
`Judge Rotenberg Educ. Ctr. v. Comm’r of the Dep’t of Dev.
`Servs., Dkt. No. 86E-0018-GI, at 2–8 (Bristol, Mass. Prob. &
`Fam. Ct., June 20, 2018). Before the Center treats a patient with
`the devices, Massachusetts requires multiple health care
`practitioners to certify that no other treatments were effective
`or that the shock treatment is not contraindicated. It further
`requires that peer review and that human rights committees
`ratify the treatment. Further, a state court must determine that
`the treatment was appropriate. Id. The intricate system of state
`regulation arose as a combination of state statutes, regulations,
`and a consent decree that the Center and Massachusetts entered
`in 1987. Id.
`
`B. Procedural background
`
`
`In April 2016, the FDA proposed banning electrical
`stimulation devices for self-injurious or aggressive behavior.
`See Banned Devices; Proposal to Ban Electrical Stimulation
`Devices Used to Treat Self-Injurious or Aggressive Behavior,
`81 Fed. Reg. 24,386 (Apr. 25, 2016). The notice of proposed
`rulemaking stated
`that
`the
`therapy presented several
`“psychological and physical risks: Depression, fear, escape and
`avoidance behaviors, panic, aggression, substitution of other
`behaviors (e.g., freezing and catatonic sit-down), worsening of
`underlying symptoms (e.g., increased frequency or bursts of
`
`
`
`

`

`5
`
`self-injury), pain, burns, tissue damage, and errant shocks from
`device misapplication or failure.” Id. at 24,387. Literature
`addressing other electrical devices that shock patients further
`suggested treatment with such devices could result in
`posttraumatic stress disorder. Id.
`
`The FDA also reviewed the evidence of the devices’
`effectiveness and concluded that the evidence was weak.
`According to the FDA, some studies showed that the devices
`immediately interrupt the targeted behavior, but that the
`evidence was
`inconclusive as
`to whether
`the devices
`“achieve[d] durable long-term reduction of [self-injurious or
`aggressive behaviors].” Id. at 24,387. In reaching those
`conclusions, the FDA reviewed the medical literature at large
`and data from the Center itself. Id. Based on the evidence of
`harm to patients, and what it regarded as weak evidence of
`durable effectiveness, the FDA determined that the devices
`presented a substantial and unreasonable risk to self-injurious
`and aggressive patients, justifying banning the devices for that
`purpose. In 2020, the FDA promulgated its final rule. See 85
`Fed. Reg. 13,312. The final rule adopted the conclusions set
`forth above on the risks and efficacy of electrical stimulation
`devices to treat self-injury and aggression. Id. at 13,315. The
`FDA, in reviewing comments, also concluded that it had the
`legal authority to ban a device for a particular purpose. Id. at
`13,345.
`
`Both the Center and parents and guardians of patients who
`receive or seek to receive treatment using an electrical
`stimulation device now petition this court to review the FDA’s
`ban raising several issues. We determine that a single issue is
`determinative of the case. That issue is: Does the FDA have
`legal authority to ban an otherwise legal device from a
`particular use? The other arguments will not require separate
`analysis.
`
`
`
`

`

`
`
`6
`
`II.
`
`Analysis
`
`
`The answer to the controlling issue is determined by the
`
`application of two statutes: 21 U.S.C. § 360f, which authorizes
`the FDA to ban medical devices, and 21 U.S.C. § 396, which
`prohibits the FDA from regulating the practice of medicine. We
`begin by setting forth the relevant portion of each statute.
`
`Section 360f, which Congress passed in the Medical
`
`Device Amendments of 1976 to the Food, Drug, and Cosmetic
`Act, grants the FDA authority to ban medical devices. The
`section provides: “Whenever the Secretary finds . . . that a
`device intended for human use presents substantial deception
`or an unreasonable and substantial risk of illness or injury,” and
`that risk cannot be “corrected or eliminated by labeling,” the
`Secretary “may initiate a proceeding to promulgate a regulation
`to make such device a banned device.” 21 U.S.C. § 360f(a).
`“Device” is a defined term within the Food, Drug, and
`Cosmetic Act, meaning “an instrument, apparatus, implement,
`machine, contrivance, implant, in vitro reagent, or other similar
`or related article, including any component, part, or accessory,
`which is . . . intended for use in the diagnosis of disease or
`other conditions, or in the cure, mitigation, treatment, or
`prevention of disease.” Id. § 321(h)(1). A banned device is
`considered adulterated, authorizing the FDA to seize the device
`if it has been or may be introduced into interstate commerce
`and making it a crime to introduce the device into interstate
`commerce or manufacture it. Id. §§ 331(a), (g); 333; 334(a)(1);
`351(g).
`
`Section 396 constrains the FDA’s authority by prohibiting
`
`it from regulating the practice of medicine. In the Food and
`Drug Modernization Act of 1997, Congress provided:
`
`
`
`
`

`

`7
`
`Nothing in this chapter shall be construed to
`limit or interfere with the authority of a health
`care practitioner to prescribe or administer any
`legally marketed device to a patient for any
`condition or disease within a legitimate health
`care practitioner-patient
`relationship. This
`section shall not limit any existing authority of
`the Secretary
`to establish and enforce
`restrictions on the sale or distribution, or in the
`labeling, of a device that are part of a
`determination of
`substantial equivalence,
`established as a condition of approval, or
`promulgated through regulations.
`
`21 U.S.C. § 396. Section 396 ensures that once the FDA
`permits a device to be marketed for one use, health care
`practitioners have the flexibility to draw on their expertise to
`prescribe or administer the device for any condition or disease,
`not just the use the FDA approved—in short, to practice
`medicine. See Buckman Co. v. Plaintiffs’ Legal Comm., 531
`U.S. 341, 349–50 (2001). Such “‘off-label’ usage of medical
`devices . . . is an accepted and necessary corollary of the
`FDA’s mission,” and indeed, duty, “to regulate in this area
`without directly interfering with the practice of medicine.” Id.
`at 350. Section 396 protects the liberty of doctors and patients
`to use approved devices in any manner they wish. See
`Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1344 (10th Cir.
`2015) (Gorsuch, J.); see also H.R. Rep. No. 105-399, at 97
`(1997) (“[T]he off-label use of a medical device by a physician
`using his or her best medical judgment in determining how and
`when to use the medical product for the care of a particular
`patient is not the province of the FDA.”).
`
`The FDA argues that section 396 does not restrict its
`
`authority under section 360f at all. It argues that section 396
`only prohibits the FDA from limiting the authority of a
`
`
`
`

`

`8
`
`practitioner to prescribe or administer a legally marketed
`device, and a device is not legally marketed if it is banned. The
`FDA also points to the Act’s definition of a “device” with
`reference to its intended use, such that it would be appropriate
`for the FDA to ban devices with reference to particular uses.
`Finally, the FDA also argues that it would be a peculiar
`construction of the statute if the statute authorizes it to ban a
`device completely, or not approve it in the first instance, but
`prohibits the FDA from using its expertise to narrowly tailor a
`ban to those circumstances in which a device presents a
`uniquely substantial risk.
`
`The petitioners contend not only that section 360f does not
`
`authorize use-specific banning, but also contend that the plain
`text of section 396 prohibits the FDA from banning a medical
`device for a particular purpose. They further argue that the
`section reserves the “tailoring” that the FDA suggests is
`appropriate to medical practitioners, not the FDA. Finally, they
`note that the FDA’s construction is not appropriate because it
`interferes with states’ traditional authority to regulate the
`practice of medicine.
`
`
`Ordinarily, we evaluate an agency’s interpretation of a
`statute it administers under Chevron USA Inc. v. Natural
`Resources Defense Council, Inc., 467 U.S. 837, 842–43 (1984).
`Under the framework, we first consider “whether Congress has
`directly spoken to the precise question at issue.” Id. at 842. If
`so, “the court, as well as the agency, must give effect to the
`unambiguously expressed intent of Congress.” Id. at 842–43.
`If Congress has not spoken clearly, we defer to an agency’s
`interpretation if it is “based on a permissible construction of the
`statute.” Id. at 843. In this case, the FDA did not invoke
`Chevron deference or even cite the case in its briefing. Perhaps
`this is because the agency concluded that the relevant statutes
`are unambiguous. We agree that the statutes are unambiguous,
`
`
`
`

`

`9
`
`although this does not mandate the FDA’s conclusion that the
`statute authorizes it to take this action.
`
`A. Statutory analysis
`
`We begin our analysis of the scope of the FDA’s banning
`authority with section 360f, the statute that authorizes banning
`in the first instance. The statute states that the FDA may make
`“such device a banned device,” and the natural reading of that
`language suggests a device either is banned or it is not. It
`speaks of no authority to place a device in an intermediate state
`of “banned in some uses.” But the statute also requires the FDA
`to determine whether the risks a device presents are reasonable,
`presumably in light of the benefits that the device provides to
`individuals that use it. If a device has multiple possible uses,
`each use will present a different benefit-risk profile. The risks
`a device presents could therefore be reasonable for some uses
`but not for others. Focusing on “reasonable” in the statute
`echoes the FDA’s reasoning that it should be permitted to tailor
`a ban to those circumstances in which it applies its expertise to
`find an unreasonable risk.
`
`However, section 396 expressly denies the FDA authority
`
`to construe any part of the Food, Drug, and Cosmetic Act,
`including its authority to ban devices under section 360f, to
`permit the FDA to “limit[] or interfere[]” with practitioners’
`authority
`to prescribe or administer “legally marketed
`device[s]” to patients. The questions for us then, are whether a
`ban “limits or interferes,” and whether a device that the FDA
`has attempted to ban for a particular purpose is “legally
`marketed.”
`
`
`A use-specific ban limits or interferes with a practitioner’s
`authority by restricting the available range of devices through
`regulatory action. Rather than being a peculiar interpretation,
`
`
`
`

`

`10
`
`as the FDA argues, this understanding is consistent with both
`the ordinary meaning of the terms “limit” and “interfere,” as
`well as Supreme Court precedent. To limit is “to restrict the
`bounds or limits of,” or “to curtail or reduce in quantity or
`extent”; to interfere, in turn, is “to interpose in a way that
`hinders or impedes: come into collision or be in opposition.”
`Interfere, Limit, Merriam-Webster.com; see also Buckman,
`531 U.S. at 350. Preventing further manufacture of a device
`and seizing existing devices both “limits” and “interferes” with
`a physician’s ability to prescribe or administer them.
`
`As to the statutory reference to “legally marketed,” a
`device is legally marketed if it is lawful for a manufacturer to
`sell the device or a practitioner to prescribe or administer it.
`The statute does not suggest, not should we read into it, a
`limitation that the device must be marketed for the particular
`use for which the practitioner wants to utilize the device.
`Indeed, that would eviscerate the statute’s protection of off-
`label use. See Buckman, 531 U.S. at 350. Any device that the
`FDA attempts to ban for one but not all uses will, accordingly,
`still be legally marketed. In this case, practitioners can still
`prescribe or administer electrical stimulation devices for other
`conditions, like smoking. 85 Fed. Reg. at 13,317. Electrical
`stimulation devices are therefore legally marketed, and as
`discussed previously, banning them for a particular use limits
`or interferes with a practitioner’s ability to administer or
`prescribe them as the practitioner sees fit. The plain meaning
`of the first sentence of section 396 demonstrates that the FDA
`does not have the authority to limit practitioners’ use of a
`device for a particular purpose.
`
`The FDA’s alternative interpretation of “legally marketed
`device” is unpersuasive. The agency argues that because the
`Act requires a device to have a use, the appropriate
`construction of “device” is a pairing of a particular instrument
`
`
`
`

`

`11
`
`with a particular use. It would follow that an electrical
`stimulation device for self-injurious and aggressive behavior is
`not a “legally marketed device” once the FDA bans that pairing
`of an instrument and use. Congress potentially had such an
`interpretation in mind, as legislative history contains references
`to the FDA being permitted to treat multiple “use[s] . . . as
`constituting a different device for purposes of classification or
`other regulation.” H.R. Rep. No. 94-853, at 14–15 (1976). That
`is not an appropriate interpretation.
`
`First, that construction would allow the FDA to escape the
`constraints of section 396 whenever it bans a device. If
`Congress wished to have section 396 apply to everything
`except the FDA’s banning authority, it could have done so.
`Instead, the statute begins “Nothing in this chapter shall be
`construed,” mandating that this section constrain the FDA’s
`banning authority. Next, interpreting the definition of
`“device” as requiring a pairing of an instrument with a
`particular use is inconsistent with the definition of “device”
`itself. Section 321 defines “device” by reference to “an
`instrument, apparatus,
`implement, machine, contrivance,
`implant, in vitro reagent, or other similar or related article,”
`focusing on the physical item itself rather than any particular
`intended use. It then uses the terms “diagnosis of disease or
`other conditions,” and “cure, mitigation,
`treatment, or
`prevention of disease,” when defining a device, not “a
`condition,” “a disease,” or “a particular disease.” The plurality
`and lack of an article in the statute render its ordinary meaning
`to be that a “device” must be intended to diagnose, cure,
`mitigate, treat, or prevent some number of conditions or
`diseases, not necessarily a particular one. Contact lenses, for
`example, are one medical device even though they treat both
`nearsightedness and farsightedness.
`
`
`
`
`

`

`12
`
`The second sentence of section 396, which authorizes the
`Secretary to “establish and enforce restrictions on the sale or
`distribution . . . of a device that are . . . promulgated through
`regulations,” does not rescue the FDA. Although one could
`colloquially refer to a ban as a restriction, there is significant
`space between the definitions of the two terms. A “restriction”
`is a “limitation or qualification,” while a “ban” is a “legal or
`otherwise official prohibition.” Black’s Law Dictionary (11th
`ed. 2019). More important, however, is the fact that the Act
`structurally segregates bans and restrictions. As usual, we
`presume that the same words, used in the same act of Congress,
`have the same meaning. Atlantic Cleaners & Dyers, Inc. v.
`United States, 286 U.S. 427, 433 (1932). Congress, in a
`subsection titled “Restricted Devices,” authorized the FDA to
`“require that a device be restricted to sale, distribution, or use
`only upon the written or oral authorization of a practitioner
`licensed by law to administer or use such device, or upon such
`other conditions as the Secretary may prescribe in such
`regulation.” 21 U.S.C. § 360j(e).
`
`The restrictions that the FDA promulgates through section
`360j(e) include, for example, requiring the special controls
`appropriate for Class II devices. See id. § 360c(a)(1)(B). By
`contrast, section 360f, authorizes the FDA to ban a medical
`device. The two separate sections would be sufficient to
`demonstrate that restrictions and bans are distinct. Looking
`more closely at the statute reinforces the point. Reading
`“restriction” in section 396 to include bans is inconsistent with
`section 360j(e), which makes clear that a restriction is a
`condition upon which a device may still be sold. If we
`somehow overlook the plain language of section 360j(e) and
`permit a ban as a restriction under section 360j(e), then section
`360f itself would be surplusage as the FDA could find all the
`banning authority it wanted elsewhere.
`
`
`
`
`

`

`13
`
`As we suggested above, we are not persuaded that because
`the FDA possesses the “greater” power to completely ban a
`medical device, it must have the “lesser” power to tailor a ban
`to only certain uses. Courts regularly recognize that a greater
`power does not imply the existence of a lesser power,
`especially when the exercise of that claimed lesser power
`uniquely offends some external constraint. States may hold
`elections for state judges or they may not, but the First
`Amendment prohibits them from “conduct[ing] elections under
`conditions of state-imposed voter ignorance.” Republican
`Party of Minn. v. White, 536 U.S. 765, 788 (2002) (quoting
`Renne v. Geary, 501 U.S. 312, 349 (1991) (Marshall, J.,
`dissenting)). States can regulate dentists or allow them to
`participate in an unregulated market, but they cannot permit
`dentists to anticompetitively self-regulate in defiance of the
`Sherman Act. N.C. State Bd. of Dental Exam’rs v. FTC, 574
`U.S. 494, 505–06 (2015). Congress may provide Medicaid
`funds to states or it may not, but once states have relied upon
`those sizeable funds, it cannot condition their receipt on an
`expansion of Medicaid without running afoul of the Tenth
`Amendment. See Nat’l Fed’n of Indep. Bus. v. Sebelius, 567
`U.S. 519, 581–83 (2012) (opinion of Roberts, C.J.). As a final
`example, and most relevant to this case, the Attorney General
`may ban all uses of certain controlled substances, but he cannot
`prohibit specific uses that states regard as legitimate medical
`practice. See Gonzales v. Oregon, 546 U.S. 243, 272–73
`(2006). In this case too, no one disputes that section 360f
`permits the FDA to ban a device completely. The FDA could
`even decline to approve a device in the first instance. The
`problem is that once the FDA approves a device and then tries
`to ban it for specific uses, it defies the limitation that section
`396 imposes. Just as in other contexts, section 396 operates as
`an external constraint—preserving the ability of physicians to
`make professional judgments about off-label uses—that
`
`
`
`

`

`14
`
`prevents the FDA from exercising a lesser power merely
`because it possesses a greater one.
`
`B. Federalism concerns
`
`While our analysis thus far has focused on the text of
`section 396, the statute’s role in preserving the balance of
`powers between the federal government and the states provides
`further support for our conclusion. “The Constitution created a
`Federal Government of limited powers.” Gregory v. Ashcroft,
`501 U.S. 452, 457 (1991). “[T]he general government is not to
`be charged with the whole power of making and administering
`laws. Its jurisdiction is limited to certain enumerated objects,
`which concern all the members of the republic, but which are
`not to be attained by the separate provisions of any.” THE
`FEDERALIST NO. 14 (James Madison). Courts have recognized
`this bedrock principle since the earliest years of the republic.
`See Marbury v. Madison, 5 U.S. (1 Cranch) 137, 176 (1803)
`(“The powers of the legislature are defined, and limited; and
`that those limits may not be mistaken, or forgotten, the
`constitution is written.”) (Marshall, C.J.).
`
`The Tenth Amendment instructs us that the powers which
`the Constitution does not delegate to the federal government
`belong to the states. U.S. CONST. amend. X. The very structure
`of the Constitution underscores the balance of powers between
`the federal and state governments “[w]ith
`its careful
`enumeration of federal powers and explicit statement that all
`powers not granted to the Federal Government are reserved.”
`United States v. Morrison, 529 U.S. 598, 618 n.8 (2000).
`Congress may legislate on naturalization, bankruptcy, patents,
`and copyrights, for example, U.S. CONST. Art. I, § 8, but cannot
`generally mandate individuals purchase particular goods or
`regulate the practice of law. See NFIB, 567 U.S. at 557–58
`(opinion of Roberts, C.J.); Am. Bar Ass’n v. FTC, 430 F.3d 457,
`
`
`
`

`

`15
`
`471–72 (D.C. Cir. 2005). As a result, before we will construe a
`statute to permit federal action in an area that is traditionally
`the province of state law, we require Congress to make its
`intention to “alter the usual constitutional balance between the
`States and the Federal Government . . . unmistakably clear in
`the language of the statute.” Will v. Michigan Dep’t of State
`Police, 491 U.S. 58, 65 (1989) (internal quotations omitted).
`
`“This principle applies with equal force to the so-called
`
`modern administrative state.” Michigan v. EPA, 268 F.3d 1075,
`1081 (D.C. Cir. 2001). Federal agencies are creatures of statute.
`They possess only those powers that Congress confers upon
`them. Bowen v. Georgetown Univ. Hosp., 488 U.S. 204, 208
`(1988). If no statute confers authority to a federal agency, it has
`none. If Congress has forbidden an agency from taking an
`action, the agency cannot so act. See FDA v. Brown &
`Williamson Tobacco Co., 529 U.S. 120, 132–33, 155–56
`(2000). Accordingly, federal agencies like the FDA are doubly
`restricted: they may only exercise powers Congress has
`delegated to them, and that delegation itself must be a lawful
`exercise of Congress’s constitutional authority. Just as we
`require a clear statement when interpreting a statute in the first
`instance, we require an explicit authorization from Congress
`before we will permit an agency to regulate in an area that alters
`the balance of powers between states and the federal
`government. See Am. Bar Ass’n, 430 F.3d at 471–72. In
`American Bar Association, a federal agency, in that case the
`Federal Trade Commission, attempted to regulate the practice
`of law. We held that it could not do so absent explicit
`authorization by Congress. See id. In this case, the Food and
`Drug Administration attempts to regulate the practice of
`medicine, not only without explicit authorization from
`Congress, but in the face of an explicit congressional command
`not to do so.
`
`
`
`
`

`

`16
`
`States, not the federal government, traditionally have
`regulated the practice of medicine. See Gonzales, 546 U.S. at
`275. Choosing what treatments are or are not appropriate for a
`particular condition is at the heart of the practice of medicine.
`See State v. Miller, 542 N.W.2d 241, 246 (Iowa 1995); State v.
`Smith, 135 S.W. 465, 469 (Mo. 1911). Indeed, Massachusetts
`has taken a very active role in regulating the Center’s use of
`electrical stimulation devices. See Judge Rotenberg Educ. Ctr.
`v. Comm’r of the Dep’t of Dev. Servs., Dkt. No. 86E-0018-GI,
`at 2–8 (Bristol, Mass. Prob. & Fam. Ct., June 20, 2018).
`Therefore, before we would permit the FDA to dictate whether
`practitioners may administer electrical stimulation therapy to
`self-injuring and aggressive patients, we would require an
`explicit statement from Congress to that effect. Will, 491 U.S.
`at 65; Am. Bar Ass’n, 430 F.3d at 471–72. When Congress
`chooses to authorize the FDA to explicitly list what conditions
`a physician can use a drug or device to treat, it does so. E.g.,
`21 U.S.C. § 333(e) (requiring human growth hormone to be
`approved for a particular purpose). In this case, we have quite
`the opposite of an explicit authorization—an explicit statement
`from Congress that the FDA cannot act. Section 396 explicitly
`limits the power of the FDA. The FDA has no authority to
`choose what medical devices a practitioner should prescribe or
`administer or for which conditions.
`
`
`CONCLUSION
`
`In the end, despite the length of our discussion, the
`
`resolution of the controlling issue is quite easily expressed.
`When Congress has spoken in a statute, we assume that it says
`what it means and that the statute means what it says. In this
`case, the statute says that the FDA is not to construe its statute
`so as to interfere with the practice of medicine. That means that
`the FDA may not enact the regulation at issue before us.
`Because we conclude that the FDA lacks the statutory authority
`
`
`
`

`

`17
`
`to ban a medical device for a particular use, we do not address
`petitioners’ other arguments, including whether the ban was
`arbitrary and capricious or whether substantial evidence
`supported the FDA’s factual determinations. We grant the
`petitions for review and vacate the FDA’s rule banning
`electrical stimulation devices for self-injurious and aggressive
`behavior.
`
`So ordered.
`
`
`
`

`

`
`SRINIVASAN, Chief Judge, dissenting: The Federal Food,
`Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., grants the
`FDA various types of regulatory authority over medical
`devices. The agency, for instance, may classify devices as
`Class I, II, or III devices, depending on the degree of risk a
`device poses. See id. § 360c(a)(1). The riskier the device, the
`greater the FDA’s power to regulate it. See id. The Act also
`vests the FDA with authority to go further: the agency can
`outright ban a device upon determining that it presents “an
`unreasonable or substantial risk of illness or injury.” Id.
`§ 360f(a)(1). A banned device cannot be manufactured,
`introduced, or received in interstate commerce. Id. §§ 331(a),
`(c), (g), 351(g). The FDA has exercised the banning power
`very sparingly in the 45 years of its existence. Medical Device
`Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539
`(codified at 21 U.S.C. § 360c et seq.). The agency has banned
`a device on just three occasions, including, most recently, the
`ban in question in this case. See 85 Fed. Reg. 13,312 (Mar. 6,
`2020) (Rule); 81 Fed. Reg. 91,722 (Dec. 19, 2016); 48 Fed.
`Reg. 25,126 (June 3, 1983).
`
`There is no dispute that the FDA has power under the
`statute to ban a medical device altogether—i.e., across all its
`potential uses. The issue in this case is whether the FDA can
`exercise its banning authority in a more tailored fashion: rather
`than ban a device across the board, can the agency ban the
`device for a particular intended use while allowing it for other
`uses? One can readily envision why the FDA might wish to do
`so. Suppose a device has been approved to treat two distinct
`conditions, meaning it has two intended uses. When treating
`the first condition, the device proves to be of limited
`effectiveness and poses an acute risk of injury. But when
`treating the second condition, the device proves highly
`effective and presents only a negligible risk of injury. The
`FDA presumably would want to ban the device for the first
`intended use but permit it for the second. And it is hard to
`perceive why Congress could want to deny the agency that
`
`
`
`

`

`2
`middle-ground option. Why force the agency to make an all-
`or-nothing choice—either abolish a highly beneficial use so it
`can stamp out a highly risky one, or stomach the highly risky
`use so it can preserve the highly beneficial one?
`
`This case is illustrative. The FDA conducted a years-long
`examination of whether to ban the use of electrical stimulation
`devices intended to treat self-injurious or aggressive behaviors.
`81 Fed. Reg. 24,386, 24,392–93 (Apr. 25, 2016) (Proposed
`Rule). Persons who engage in those behaviors often suffer
`from intellectual or developmental disabilities. Id. at 24,389.
`Electrical stimulation devices deliver a powerful and painful
`electric shock to the wearer’s skin, in an effort to punish and
`thereby discourage self-injurious and aggressive behaviors
`when they manifest. Id. That type of treatment has fallen