Petition for Writ of Certiorari — Anita Louise Jackson, Petitioner v. United States

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APPENDIX A

PUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

No. 23-4467

UNITED STATES OF AMERICA,

Plaintiff - Appellee,

v.

ANITA LOUISE JACKSON,

Defendant - Appellant.

PHYSICIANS AGAINST ABUSE, INC.,

Amicus Supporting Appellant.

No. 23-4587

UNITED STATES OF AMERICA,

Plaintiff — Appellee,

v.

ANITA LOUISE JACKSON,

Defendant - Appellant.

PHYSICIANS AGAINST ABUSE, INC,

Amicus Supporting Appellant.

Appeal from the United States District Court for the

Eastern District of North Carolina, at

Raleigh. James C. Dever, III, District Judge. (5:21-cr00259-D-l)

Argued: November 1, 2024 Decided: January 21, 2025

Before DIAZ, Chief Judge, AGEE, and BENJAMIN,

Circuit Judges.

Affirmed by published opinion. Judge Agee wrote the

opinion in which Chief Judge Diaz and Judge Benjamin

joined.

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ARGUED: Elliot Sol Abrams, CHESHIRE PARKER

SCHNEIDER, PLLC, Raleigh,

North Carolina, for Appellant. Katherine Twomey Allen,

UNITED STATES

DEPARTMENT OF JUSTICE, Washington, D.C., for

Appellee. ON BRIEF: Ripley E.

Rand, WOMBLE BOND DICKINSON (US) LLP, Raleigh,

North Carolina, for Appellant.

Nicole M. Argentieri, Principal Deputy Assistant Attorney

General, Lisa H. Miller,

Criminal Division, UNITED STATES DEPARTMENT OF

JUSTICE, Washington, D.C.;

Michael F. Easley, Jr., United States Attorney, David A.

Bragdon, Assistant United States

Attorney, Appellate Chief, OFFICE OF THE UNITED

STATES ATTORNEY, Raleigh,

North Carolina, for Appellee. Eric O. Husby, HUSBY

LAW, Land O Lakes, Florida, for

Amicus Curiae

AGEE, Circuit Judge:

Dr. Anita Jackson appeals her convictions for various

offenses arising from the operation of her private medical

practice in North Carolina. She raises multiple arguments

challenging her conviction for violating the Food, Drug,

and Cosmetics Act (“FDCA”) by holding for re-sale

adulterated medical devices, in violation of 21 U.S.C. §

331(k). Flowing from her challenge to the FDCA

conviction, she also asserts that the prejudicial spillover

effect of evidence introduced to support that count

requires vacatur of her other convictions. And, assuming

her case is remanded for a new trial, she submits that

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the Court should reassign the case to a different district

judge. Separately, Jackson challenges her convictions for

two counts of aggravated identity theft, in violation of 18

U.S.C. §§ 1028A(a)(l) and 2.

Finding no reversible error as to any of the challenged

convictions, we affirm.

I.

Jackson is a board-certified otolaryngologist, commonly

referred to as an ear, nose, and throat physician. During

the relevant timeframe, she ran a multi-location private

practice in Lumberton and Rockingham, North Carolina.

At one time, Jackson was the leading Medicare biller in

the nation for a procedure known as balloon sinuplasty

surgery, which treats chronic sinusitis.2 The procedure

consists of the doctor inserting a device through the

patient’s nose into one or more of the sinuses and inflating

a small balloon to widen the cavity. The device Jackson

used for this procedure during the relevant timeframe was

an Entellus XprESS Multi-Sinus Dilation

Tool (“Entellus” or “the device”). The insertable part of

this device has a small tip, an inflatable balloon, and a

thin hollow metal tube. The balloon slides up and down

the tube and is inflated after it is placed in the patient’s

sinus cavity. The rest of the Entellus remains outside the

patient’s body and consists of the slide mechanism for the

balloon, a suction port, and a light fiber that runs through

the hollow tube to allow the physician to see into

the sinus during the procedure. The device also has small

retractable parts that often come into contact with and

trap bodily fluids and hair from the patient during the

procedure. These parts are fragile and may break easily,

particularly if the Entellus is reused. The device was,

accordingly, designed for single use and is labeled by the

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Food and Drug Administration as being approved only for

single use. Physicians who perform sinuplasty surgeries

can be reimbursed by Medicare. In fact, this particular

procedure does not require preapproval to submit a claim.

Medicare reimbursement levels for sinuplasty and other

procedures factor in “three main parts: The amount of

time and effort it takes to provide service, the costs

associated with that service that the doctor will incur, and

the costs that the[] doctor incurs for malpractice.” J.A.

1402.

This formula, which takes into account the cost of the

equipment needed to perform the procedure, was used to

calculate Medicare’s reimbursement amounts for a

sinuplasty using the Entellus. Becoming the nation’s

leading Medicare biller for sinuplasty surgery was far

from happenstance, as Jackson’s employees recounted

how she incentivized recruiting Medicare patients to

agree to the procedure. For her employees, Jackson tied

work hours to surgery marketing efforts, set surgery

quotas for her offices, and paid bonuses related to how

many sinuplasty procedures were performed. She

encouraged employees to recruit patients throughout the

community, targeting rural localities and seeking out

individuals likely to have Medicare because it did not

require preapproval for the procedure. Employees

testified, for example, that they were told to pitch balloon

sinuplasty to potential patients at locations like Wal-Mart

parking lots, churches, barbershops, and doctor’s offices.

In addition, Jackson offered some potential patients

financial enticements such as not requiring any front

payment or limiting fees to a $50 copayment rather than

the higher Medicare-directed copayment amounts. By

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agreeing to have the sinuplasty procedure, patients could

also receive free transportation to Jackson’s office and gift

cards to local stores. In conjunction with these efforts to

drum up new sinuplasty patients, Jackson streamlined

the process she followed before deeming a patient eligible

for the procedure. Early on, Jackson ordered diagnostic

scans and considered alternative treatments before

performing the procedure. Later, Jackson would simply

perform the procedure on a patient’s first visit,

implementing what Jackson’s employees termed an

“assembly line” to “get to ‘yes ” for the sinuplasty to be

performed, thereby skipping a bona fide assessment

of the patients’ medical condition, alternative treatments,

or even determining whether the procedure was medically

appropriate. J.A. 1766, 1953-55.

In many cases, Jackson’s recruitment efforts left patients

without understanding that the proposed procedure was

actually a surgery. Instead, it was described to them as a

“sinus spa” or “rinse.” J.A. 1749—50, 2045. Many patients

were also unaware that the procedure worked by having

the balloon micro-fracture bones. And they were similarly

unaware that Jackson elected to perform the procedure

using the same device on more than one patient. Instead,

patients were informed that a “small sterile balloon”

would be used during the procedure. S.J.A. 172. When

investigators searched Jackson’s offices, they discovered

that aged, used devices were being stored loose in

drawers. Those conditions were typical. Employees

reported that many Entelluses used on patients were

rusted and the retractable parts no longer operated

smoothly. After use, Jackson’s employees would wash the

device using a variety of cleaning methods because they

were not given clear instructions for how to do so. They

lacked appropriate tools to assist in cleaning

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the devices’ hollow and delicate parts, and they could not

see many areas of an Entellus to ensure that it was clean,

much less sterile. Usually, employees would wash the

device with tap water and soap while gently scrubbing it

so as not to break any of its parts. They would then place

it in two chemical solutions for around thirty minutes

(well below the solutions’ recommended cleaning times),

rinse with tap water, and then leave the device to dry on

top of a pad on the counters of exam rooms. Once dry, the

Entelluses were put in drawers where they were

interspersed with other supplies. This process created a

significant likelihood that some reused devices still

contained prior patients’ bodily fluids.

Jackson’s billing practices related to sinuplasty surgeries

drew the attention of federal investigators, and she was

audited four times between 2016 and 2018. After a 2016

audit, Jackson was forced to repay over $30,000 in

Medicare reimbursements because of noncompliant

(incomplete) recordkeeping. The 2016 audit did not cause

Jackson to implement better recordkeeping measures;

instead, she and her employees began falsifying

documents to support her billing practices. The record

shows that each time Jackson was informed of an audit

and asked to produce complete copies of her medical

records supporting various claims, she submitted altered

records.3 Specifically, Jackson created entirely new

records, omitted incomplete records, and changed other

records. In response to one of the 2018 audits (the “2018

Palmetto audit”), Jackson submitted declarations

purporting to be from sinuplasty patients. The

declarations represented that the patients had chronic

sinusitis and had been unsuccessfully treated with

antibiotics before Jackson performed the sinuplasty

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surgery. The declarations contained a statement

representing the truth and correctness of the contents,

under penalty of perjury. Some of the declarations,

including those belonging to patients with the initials of

L.J. and W.F., contained false notarizations and forged

signatures.3 As a result of the audits and related

investigations into Jackson’s practice, a grand jury

returned an indictment charging Jackson with an array of

federal crimes. The twenty count superseding indictment

alleged the following offenses:

• Count 1: violating 21 U.S.C. § 331(k) by holding for

resale adulterated medical

devices, namely, the Entellus with which Jackson

performed the sinuplasty

surgeries;

• Counts 2-11: violating the federal anti-kickback

statute, 42 U.S.C. § 1320a-7b, by billing Medicare for

procedures without advising patients of their copayment

responsibilities and without collecting copayments from

patients, as required by federal law;

• Counts 12—14: making materially false statements, in

violation of 18 U.S.C. §§ 1035(a)(2) and 2, during the

course of the three 2017 to 2018 Medicare audits;

• Counts 15—16: committing aggravated identity theft,

in violation of 18 U.S.C. §§ 1028A(a)(l) and 2, by

submitting forged and fabricated documents purportedly

from patients L.J. and W.F. as part of Jackson’s response

to the 2018 Palmetto audit described in Count 14;

• Counts 17—19: committing mail fraud, in violation of

18 U.S.C. §§ 1341, 1349, and 2, relating to mailing

falsified documents responding to the audits described

in Counts 12 to 14; and

• Count 20: conspiring to commit the federal offenses

described in the prior counts, in violation of 18 U.S.C. §

371.

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During the multi-week trial that ensued, the jury heard

evidence from multiple witnesses, including Jackson’s

employees and patients, as well as the designer of the

Entellus. In addition, Jackson testified in her defense.

After the presentation of evidence, the jury convicted

Jackson on all charges, specifically finding that she acted

with the intent to defraud or mislead as to the FDCA

violation (Count 1) and that she had obtained

$4,794,039.31 as “gross proceeds traceable to the

commission of the federal health care offenses.” J.A.

3657.4 Jackson moved for a judgment of acquittal as to

Counts 2 through 19 (but, notably, not Count 1) and

included a blanket cross-reference to “the entirety of her

preserved objections, submissions, legal arguments,

motions, denials of said motions, requests, and rights

preserved in the trial record ... as grounds for [a] motion

for new trial.” J.A. 3674. The district court denied these

motions. Jackson was sentenced to a below-Guidelines

sentence of twenty-five years’ imprisonment and ordered

to pay $5,726,218.26 in restitution. Jackson noted a timely

appeal, and the Court has jurisdiction under 28 U.S.C. §

1291.

II.

In this appeal, Jackson does not directly challenge

seventeen of her convictions.5 As to the FDCA conviction

(Count 1) and aggravated identity theft convictions

(Counts 15 and 16), she raises multiple arguments.

Although Jackson also broadly contends that she is

entitled to vacatur and remand for a new trial as to all of

her convictions, those arguments all flow solely from

errors that she claims occurred as to Count 1, which she

contends prejudicially infected the rest of the trial.

We begin by considering Jackson’s challenge to Count 1,

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in which she was charged with violating the FDCA. Two

elements of the offense are undisputed—that the conduct

at issue involves a “device” as that term is defined in the

FDCA, and that the devices had been shipped in

interstate commerce. The remaining elements are, in

relevant part, that the defendant (1) engaged in

prohibited conduct with respect to the device, (2) while the

device was “held for sale (whether or not the first sale),”

and (3) the prohibited conduct resulted in the device

“being adulterated.” § 331(k).6 The prohibited conduct set

out above encompasses “two distinct offenses,” the first

relating to the label itself and potential misbranding and

the second—the conduct at issue here—relating to

adulteration, which “is concerned solely with

deterioration or contamination of the commodity itself.”

United States v. Wiesenfeld Warehouse Co., 376 U.S. 86,

89-90 (1964). The FDCA states that a “device shall be

deemed to be adulterated” “if it has been prepared,

packed, or held under insanitary conditions whereby it

may have been contaminated with filth, or whereby it may

have been rendered injurious to health.” 21 U.S.C. §

351(a)(2)(A).6 Jackson raises several arguments aimed at

undermining her conviction on Count 1, asserting

alternatively that problems with the indictment require

dismissal of the charge outright or that trial errors require

vacatur of the conviction and remand for a new trial. As

reflected in the analysis that follows, most of Jackson’s

arguments are raised here for the first time on appeal. The

fact that she failed to preserve those issues affects our

standard of review, as outlined below.

In broad terms, Jackson presses the following

arguments: (1) the Entellus devices were not “held for

sale,” as required to violate § 331(k); (2) her actions were

protected under 21 U.S.C. § 396, which she claims

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insulates certain physician conduct that would

otherwise violate § 331(k) so long as it occurs within a

legitimate

doctor-patient

relationship;

(3)

the

Government relied on a defective theory of per se

adulteration arising from re-use of a device labeled for

single use; (4) she should have been permitted to

demonstrate her cleaning and sanitation process as part

of her defense; (5) she should have been permitted to

introduce documentary evidence about the prevalence of

re-using single use devices and proper sanitization as part

of her defense; (6) the jury should not have been instructed

that it was “irrelevant” that none of her patients were

harmed or that she believed the device was clean; and (7)

the Government made an improper “Golden Rule”

argument during closing argument. We address each of

these contentions in turn.7 Jackson posits that the

indictment was deficient, the jury instructions erroneous,

and the evidence insufficient to support the verdict. She

argues that each of these alleged errors permitted the

element of § 331(k) requiring that the device be “held for

sale” to be satisfied by conduct falling outside the scope of

that statutory language. In sum, Jackson asserts that, at

most, she held the Entelluses for use during sinuplasty

surgeries and that they were not “held for sale” to her

patients. Her rationale is that she did not hold the devices

for sale because ownership of or title to an Entellus never

transferred to the patient as a part of the procedure. In

her view, because “re-use” falls outside the scope of

holding the device “for sale,” the indictment should have

been dismissed because it did not charge her with conduct

that the statute prohibits. She further asserts that this

mismatch between the statutory language and her

conduct carried forward to the jury instructions, which

stated that “[t]he phrase ‘held for sale’ includes a single-

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use device that a doctor used in the course of treating a

Medicare patient. A device is ’held for sale’ at the time the

holder of the device, including a doctor, intends it to be

sold or used in the course of treating a Medicare patient.”

J.A. 3515. For the same reasons, she asserts the trial

record is insufficient to support her conviction.

Because Jackson makes each of these arguments

centered on the Entellus being “held for sale” for the first

time on appeal, we apply plain-error review. See Puckett

v. United States, 556 U.S. 129, 134—35 (2009) (stating that

appellate courts review “unpreserved claim[s] of trial

error” for plain error). Before proceeding with that review,

however, we briefly discuss our basis for concluding that

she failed to preserve any argument with respect to

whether the Entellus was “held for sale.” Jackson first

maintains that she preserved her argument related to the

indictment by moving to dismiss Count 1 for failure to

state an offense. Reviewing Jackson’s arguments in

support of that motion reveals that she asserted three

reasons why Count 1 should be dismissed. First, she

claimed that § 331(k) was “[u]nconstitutionally [v]oid for

[v]agueness,” J.A. 138, because it failed to adequately

notify individuals when a device is left in sufficiently

unsanitary conditions so as to be deemed “adulterated.”

Second, she argued the indictment did not sufficiently

allege her intent to defraud or mislead her patients. Third,

she claimed that the indictment did not allege that she

failed to engage in a permitted off-label use of the

Entellus. None of these arguments challenges any aspect

of the “held for sale” element of § 331(k), let alone reflects

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some variant of the specific grounds she raises on appeal

about this element. We therefore reject her contention

that her motion to dismiss the indictment was sufficient

to preserve the issue she now brings before the Court.8 As

for the jury instructions on this matter, Jackson did not

object to them and instead expressed that she was

“satisfied with” the instructions to which she did not

object. J.A. 3401. So that part of her argument likewise

was never brought before the district court. Lastly,

Jackson did not move for judgment of acquittal on a basis

remotely related to whether the Entellus was “held for

sale,” so she also failed to preserve that component of her

argument.

The Supreme Court set out the standard for plain­

error review in United States v. Olano, 507 U.S. 725

(1993). First, there must be an error. Id. at 732-33.

Second, the error “must be clear or obvious, rather than

subject to reasonable dispute.” Puckett, 556 U.S. at 135

(citing Olano, 507 U.S. at 734). “Third, the error must

have affected the appellant’s substantial rights, which in

the ordinary case means he must demonstrate that it

‘affected the outcome of the district court proceedings.’” Id.

(quoting Olano, 507 U.S. at 734). Fourth, even when “the

above three prongs are satisfied, the court of appeals has

the discretion to remedy the error—discretion which

ought to be exercised only if the error seriously affect[s]

the fairness, integrity or public reputation of the judicial

proceedings.” Id. (cleaned up) (emphasis in original).

Notably, only one circuit court has confronted the

merits of this particular “held for sale” issue in a directly

analogous context, and it has rejected Jackson’s

argument. In United States v. Kaplan, 836 F.3d 1199 (9th

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Cir. 2016), the Ninth Circuit rejected the argument that a

physician merely held for “use” (and not for “sale”) single­

use devices used during biopsy exams. Id. at 1208. The

Ninth Circuit held that § 331(k)’s requirement that the

allegedly adulterated device be ‘“held for sale’ included a

physician’s use of a device in treating patients.” Id. In

doing so, it relied on the statutory text and the purpose of

the FDCA, noting that the statute “is to be interpreted

broadly in order to protect public health.” Id. It also

recounted the reasoning of other courts that had

interpreted this phrase, recognizing that it “extends to

physicians using both drugs and devices in the treatment

of patients” given the commercial nature of a physician’s

treatment of patients. Id. at 1209. Agreeing with this

reasoning, the Ninth Circuit described the doctor-patient

relationship as setting up a “sale” of services, with the

device being part and parcel of those services. Id. at 1210

(a “physician [is] engaged in the business of providing

medical services in exchange for payment: a commercial

actor in a commercial setting, using a commercial

product”). The Ninth Circuit also placed particular

significance on the “single-use nature” of the device at

issue in that case, observing that such devices are “meant

to be ‘consumed’ in the course of treating a patient—just

like a drug.” Id. It then elaborated:

Once the single-use device is used or consumed

there is nothing left to be done with the device. It

no longer possesses a functional purpose in the

medical practice and, rather than giving the used

device to the patient, the doctor disposes of it.

Therefore, when a physician uses a disposable

device on a patient, the device is “held for sale”

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within the meaning of the FDCA provided that

there is a commercial relationship between the

doctor and the patient and that the device is one

that is meant to be ‘consumed’ in the process.

Id.

While

acknowledging

the

common-sense

persuasiveness of the Ninth Circuit’s reasoning and the

body of caselaw from other courts on which it rests, we do

not ultimately need to determine whether we would hold

the same. Even were we to assume that Kaplan

was wrongly decided and that Jackson can demonstrate

error, her argument fails at the second prong of plain­

error review—she cannot show a clear or obvious, i.e., a

“plain,” error. See Olano, 507 U.S. at 734 (“‘Plain’ is

synonymous with ‘clear’ or, equivalently, ‘obvious.’”). In

discussing this prong, the Supreme Court has recognized

that, “[a]t a minimum, court[s] of appeals cannot correct

[unpreserved] error pursuant to Rule 52(b) unless the

error is clear under current law.” Id. Thus, we have

previously recognized that “[a]n error is plain ‘if the

settled law of the Supreme Court or this circuit

establishes that an error has occurred.’” United States v.

Carthorne, 726 F.3d 503, 516 (4th Cir. 2013) (quoting

United States v. Maxwell, 285 F.3d 336, 342 (4th Cir.

2002) (citation omitted)).

Applying this understanding of what constitutes

“plain” error to this case, we observe that it’s not “obvious”

that Jackson’s conduct falls outside the meaning of “held

for sale” as it is used in § 331(k). Neither the Supreme

Court nor we have taken a position

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on this issue, placing it outside the ordinary

circumstances in which we would conclude error is “plain.”

And we have previously recognized that a “district court

does not commit plain error by following the reasoning of

another circuit” “where we have yet to speak directly on a

legal issue and other circuits are split.” United States v.

Strieper, 666 F.3d 288, 295 (4th Cir. 2012) (citing United

States v. Rouse, 362 F.3d 256, 263-64 (4th Cir. 2004)); cf.

United States v. Alli-Balogun, 72 F.3d 9, 12 (2d Cir. 1995)

(per curiam) (stating, “we do not see how an error can be

plain error when the Supreme Court and this court have

not spoken on the subject, and the authority in other

circuit courts ig split”). If a position in line with one side

of an existing sister-circuit split cannot cause error to be

plain, a fortiori, a position in line with the sole circuit

court to address an issue cannot be obviously wrong. In

short, where the only circuit court to address the issue

goes against the defendant, as does a substantial body of

case law across courts addressing underlying points that

the circuit court relied on, any error by the district court

in this case was not “plain.” Accord United States v. Green,

996 F.3d 176, 185 (4th Cir. 2021) (recognizing that an

error is “clear” or “obvious” when, even though there is no

binding precedent from the Supreme Court or the Fourth

Circuit, circuit courts of appeals “have uniformly taken a

position” contrary to the district court’s).

We therefore reject Jackson’s assertion that the

conduct relied on to support the indictment and her

conviction falls outside the scope of § 331(k) because it

does not involve the device being “held for sale.”

B.

Jackson next argues that the district court erred by

failing to recognize that 21 U.S.C. § 396 protects

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physicians from being prosecuted under § 331(k) for offlabel use of medical devices that occur within a doctor­

patient relationship. That central premise forms the basis

of another multi-faceted assertion of error: (1) that the

district court should have dismissed the indictment for

failure to allege that the relied-on conduct occurred

outside a doctor-patient relationship, (2) that the court

abused its discretion by rejecting her proposed jury

instruction that “[i]n order to find [her] guilty of the

[FDCA] offense . . . [it] must find that the defendant was

not acting within the scope of ... a legitimate doctor

patient relationship when she re-used the medical device

at issue in this case,” J.A. 238; and (3) that the court

should have entered a judgment of acquittal because

insufficient evidence existed to prove that Jackson acted

outside of a legitimate doctor-patient relationship.9

All three facets of this argument rest on a

fundamental misunderstanding of the relationship

between §§ 396 and 331(k). Moreover, adopting Jackson’s

position would thwart congressional intent and create a

huge loophole in the FDCA. See United States v.

Regenerative Sciences, LLC, 741 F.3d 1314, 1320 (D.C.

Cir. 2014) (observing that “classifying [acts prohibited by

other provisions of the FDCA] as the practice of medicine”

for purposes of § 396 would “create an enormous gap in

the FDCA’s coverage”). The mere fact that the individual

charged is a physician cannot be sufficient to prohibit

prosecution under § 331(k). On its face, § 331(k) prohibits

certain conduct, regardless of the individual who engages

in that conduct. So, nothing in § 331(k) itself suggests that

it would not apply to a physician who engaged in the

proscribed conduct.

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Although § 396 protects a doctor’s ability to

practice medicine by limiting how the FDCA is to be

applied to them, the statute does not apply to the

circumstances presented here. In that regard, the statute

provides:

Nothing in [the FDCA] 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 Emit 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. Further, this

section shall not change any existing prohibition on

the promotion of unapproved uses of legally

marketed devices.

§ 396. In discussing this provision, the Supreme Court has

recognized that it protects “offlabel”

usage of medical devices, which it understood to mean

“use of a device for some purpose other than that for which

it has been approved by the FDA.” Buckman Co. v.

Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001).

The principal problem with Jackson’s argument is

that she equates the sort of off label usage that § 396 is

designed to protect with the holding for sale of an

adulterated device, an action not protected by the statute.

Section 396 protects only physicians who

30

“prescribe or administer any legally marketed device”

(emphasis added). The FDCA bars adulterated devices

from the stream of commerce entirely, so they cannot be

lawfully sold. 21 U.S.C. § 331(a), (c). They therefore are

not legally marketed devices within the meaning

of § 396. Judge Rotenberg Educ. Ctr., Inc. v. U.S. FDA, 3

F.4th 390, 397 (D.C. Cir. 2021). And while off-label use is

“an accepted and necessary corollary of the FDA’s mission

to regulate in this area without directly interfering with

the practice of medicine,” Buckman Co., 531 U.S. at 350,

holding adulterated devices for sale is not.

Once again, the Ninth Circuit’s decision in Kaplan

addressed and rejected the view Jackson espouses of how

§§ 331(k) and 396 operate. And on this point, we expressly

agree with its conclusion that “[w]hile a physician may

exercise professional judgment in the off label use of

unadulterated products, nothing in the FDCA or caselaw

suggests that the use of adulterated products is ever

permissible.” 836 F.3d at 1211; accord United States v.

Cal. Stem Cell Treatment Ctr., Inc., 117 F.4th 1213, 1220

(9th Cir. 2024).10 Section 396 simply

does not cover the type of conduct at issue in the charged

violation of § 331(k) proven at trial here. We therefore

reject Jackson’s argument to the contrary.

C.

Allied with her defective § 396 theory, Jackson also

argues that her § 331(k) conviction cannot stand because

it is grounded in a faulty theory that re-use of a device

labeled for single use constitutes per se adulteration. In

her view, “FDA-mandated labels

do not have the force of law as to doctors’ use of devices”

and “it cannot be a per se violation of the FDCA for a

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doctor to use a device in a manner different from the way

its manufacturer intended as provided on the label—

including reusing a device labeled as a ‘single use’ device.”

Opening Br. 45, 47. She contends that because the

indictment, jury instructions, and evidence were directed

to show that she was liable based on this flawed

theory, the Court should vacate her conviction and

dismiss the charges.il

We reject Jackson’s argument because it

misunderstands the basis for her conviction. In short, her

conviction followed statutory requirements and is not

based on the theory she claims as the Government’s basis

for her prosecution. To the contrary, the theory for holding

Jackson liable was that she “held for sale” an adulterated

device—exactly as § 331(k) envisions. That fact is borne

out in both the superseding indictment and the jury

instructions, as well as how the Government prosecuted

the case.

For example, the superseding indictment

repeatedly cited and quoted § 331(k) and

§ 351(a)(2)(A)’s statutory language about when a violation

occurs and when a medical device is adulterated. In

connecting that statutory language to Jackson’s alleged

violation, the indictment described why the Entellus could

not be cleaned effectively or sterilized. It also described

the conditions in Jackson’s practice that caused the device

to be adulterated. This language does not suggest that

mere off-label use such as re-use of a device labeled for

single use was a per se basis for charging Jackson with

violating § 331(k).

32

The jury instructions similarly tracked the

statutory language for what constitutes a § 331(k)

violation and adulteration. At no time was the jury

instructed that it could convict Jackson solely based on

her re-use of a device labeled for single use. Indeed, the

only time the instructions mentioned that the device was

labeled for “single-use” is in the context of finding

Jackson’s intent to defraud—an add-on finding to the

threshold determination that Jackson had violated §

331(k). That instruction provided the example that “if [the

jury] f[ou]nd beyond a reasonable doubt that [Jackson] did

not disclose to a patient that she was

reusing a single-use . . . device that she had used on a

different patient and that one of her reasons for doing so

was to enrich herself, then the Government has proven an

intent to defraud and mislead.” J.A. 3516. This finding

about Jackson’s intent became relevant only after the

jury’s initial determination that the device was

adulterated and that Jackson had violated § 331(k).12

To be sure, that the Entellus was labeled for single

use came up at trial. And rightly so, as it was relevant

background information. But the testimony at trial

centered on why the device had been labeled for single use,

not on the fact that it was labeled so. Parallel with

evidence about the Entelluses’ labeling, the Government

developed a thorough case about what happened to the

device after its first use and the risks associated with

attempting to clean a used device and then reusing it. And

the totality of that evidence was directly relevant to the

issue before the jury—whether Jackson had “do[ne] any

other act with respect to” the device while it was being

“held for sale” that “resulted] in such [device]

being adulterated.” § 33l(k). In addition, evidence about

33

the Entellus’s single-use label was relevant to

establishing how Medicare reimbursed doctors for

performing a sinuplasty procedure on patients, and it

supported the Government’s theory about Jackson’s profit

motive for engaging in the prohibited conduct. But again,

it was not the single-use labeling that formed the basis for

finding that the Entelluses were adulterated.

In sum, Jackson’s argument ignores large swaths of

the Government’s case and myopically focuses on and

takes out of context one component of admitted evidence

to argue that a theory of per se adulteration from re-use

led to her conviction. Based on the totality of the record,

including the language of the superseding indictment and

the jury instructions, we reject this argument.

D.

Jackson also argues that the district court

improperly curtailed her ability to present her defense

when it prohibited her from introducing a video she

recorded in which she demonstrated how she cleaned the

Entellus. She maintains that the district court mistakenly

believed that she wanted to testify as an expert witness

when her purpose was to offer lay testimony about “how

she cleaned and sanitized the device[],” so that the jury

would hear her side of the story. Opening Br. 54.

The record presents a different picture of why the

district court disallowed this evidence. The night after

Jackson began to testify at trial, her attorneys disclosed

for the first time their intent to introduce a video

recording the following day when Jackson resumed her

testimony. The video would depict Jackson demonstrating

her cleaning methods, taking culture samples from the

34

device, and then handing over the samples for testing.

Initially, Jackson explained to the court that she wanted

to introduce the video as background evidence for

introducing her testimony both about her cleaning

methods and about the results of the culture tests, with

the Government, observing that this request was a

“blatant violation of Rule 16 and [the court’s] scheduling

order,” J.A. 3078, and was “an effort to have [Jackson]

testify as an expert” without following the pre-trial

process, J.A. 3079. Jackson then shifted gears, asking the

court if it would permit a silent version of the video

recording to play while Jackson testified about it as “an

example of how she washes [the device].” J.A. 3080. The

district court denied that request too, observing “there’s a

process of reviewing information or videos like this in a

timely fashion. And to produce it the night before—in the

middle of testimony .... No lawyer has tried to do this,

and it’s because it’s patently improper.” J.A. 3080.

Jackson’s arguments on appeal fail to grapple with

the fundamental ground of untimeliness that the district

court relied on when denying admission of the video,

regardless of whether it was classified as expert testimony

or not. Because Jackson requested discovery from the

Government, Federal Rule of Criminal Procedure

16(b)(l)(A)(ii) required Jackson to allow inspection of any

evidence she wished to use in her “case-in-chief at trial.”

The district court’s scheduling order required Jackson to

make her Rule 16(b) disclosures by July 2022—six months

before Jackson did so. S.A. 2.

District courts have broad discretion “in all rulings

related to the admission and exclusion of evidence, and

this Court will not reverse the decision to exclude such

35

evidence absent abuse of that discretion.” United States v.

Holmes, 670 F.3d 586, 598 (4th Cir. 2012). We see no

abuse of discretion in the district court’s refusal to reward

Jackson for her disregard of the court’s scheduling order.

We reject Jackson’s evidentiary challenge to the exclusion

of her video evidence. 13

E.

Jackson’s second evidentiary argument relates to

the district court’s exclusion of certain documents about

disinfection and sterilization from the Centers for Disease

Control and Prevention (“CDC”). Though their specifics

vary, the documents generally discuss

sterilization techniques for medical equipment. One such

document, titled “Reuse of Single-Use Medical Devices,”

recounts that “[a]pproximately 20 to 30% of U.S. hospitals

reported that they reuse at least one type of single-use

device.” J.A. 3638. When ruling on their admissibility, the

district court excluded them as hearsay and rejected

Jackson’s argument that they were nonetheless

admissible to show their effect on her and thereby had the

potential to negate a finding that she intended to defraud

her patients.

On appeal, Jackson again asserts that these

documents were admissible for a purpose other than for

their truth, i.e., for their effect on her. She contends that

had this evidence been admitted, the jury “may well have

had a reasonable doubt as to whether [she] had a reason

to cover up her re-use of devices, and thus may have

acquitted her of the adulteration offense [.]” Opening Br.

55.

Assuming, without deciding, that the evidence was

admissible, we conclude that any purported error was

36

harmless. To prove nonconstitutional error harmless, “the

Government must demonstrate that the error did not have

a ‘substantial and injurious effect or influence in

determining the jury’s verdict.’” United States v. Curbelo,

343 F.3d 273, 278 (4th Cir. 2003) (quoting Kotteakos v.

United States, 328 U.S. 750, 776 (1946)). “An appellate

court does not inquire into whether absent the error

sufficient evidence existed to convict, but rather whether

we believe it highly probable that the error did not affect

the judgment.” United States v. Ibisevic, 675 F.3d 342, 350

(4th Cir. 2012) (internal quotation marks and citation

omitted). So, to affirm, we “must be able to ‘say, with fair

assurance, after pondering all that happened without

stripping the erroneous action from the whole, that the

judgment was not substantially swayed by the error.’” Id.

(citation omitted). We have the requisite “fair assurance”

here. The CDC documents provide scant support for the

propositions Jackson uses them to advance. None of them

address the disinfection or sterilization of the Entellus or

a similar device. And the document about re-use of single

use devices likewise does not mention this device as one

that is reused by other medical providers. At bottom, the

documents do not show that this device could be sterilized

effectively or that Jackson was justified in believing that

they could be. For this reason, we conclude it is “highly

probable that [their exclusion] did not affect the

judgment.” Ibisevic, 675 F.3d at 350 (quotation marks and

citation omitted).

F.

Next, Jackson asserts the district court prejudiced

her case by instructing the jury that it was “irrelevant”

that no patient was harmed. 14 The instructions she

challenges were given in response to objected-to

questioning during her testimony (i.e., not immediately

before deliberations). Though the specific instructions

37

vary, in each instance, the district court returned the

jury’s attention to the Government’s burden with respect

to the § 331(k) violation, cautioning them, for example,

that evidence that no patients were harmed as a result of

Jackson’s methods “is irrelevant. . . . The United States

does not have to prove in Count 1 that a single patient got

sick because of the defendant’s process.” J.A. 3167.

Jackson contends these instructions erroneously

prohibited her “from showing that the devices were not

adulterated,” “that she had no motive to—and thus did

not—adulterate the devices ... or otherwise scheme to

cover up the fact that she was using dirty devices,”

and that they “misinformed the jury about how they

should consider evidence related to adulteration.”

Opening Br. 60.

Jackson’s argument misapprehends what § 331(k)

required of the Government. As the statutory definition

makes clear, the district court was correct when it

instructed that § 331(k) did not require proof of actual

harm to patients for a jury to find that the Entellus

had been adulterated. Section 351(a)(2)(A) states that a

device “shall be deemed to be adulterated” if it is “held

under insanitary conditions whereby it may have been

contaminated by filth, or whereby it may have been

rendered injurious to health.” (Emphases added). A device

can satisfy this definition without causing someone actual

harm; it is sufficient that the potential for contamination

or injury exist. Thus, the district

court was well within its discretion to instruct the jury to

that effect.

G.

Jackson’s final challenge to this count contends

38

that reversible error occurred during the Government’s

closing argument as a result of an impermissible “Golden

Rule” argument. An invitation “urg[ing] jurors to identify

individually with the victim” is an improper “Golden Rule”

closing argument. United States v. Huskey, 90 F.4th 651,

671 (4th Cir. 2024) (quoting United States v. Al-Maliki, 787

F.3d 784, 795 (6th Cir. 2015)); accord

United States v. Moreno, 947 F.2d 7, 8 (1st Cir. 1991)

(observing that improper “golden rule” arguments

“encourageQ the jury to depart from neutrality and to

decide the case on the basis of personal interest and bias

rather than on the evidence”). “A golden-rule objection

typically arises when a lawyer asks jurors to place

themselves in the plaintiffs position with respect to the

calculation of damages,” with “[t]he rationale for

prohibiting such an argument [being] that the jury’s

sympathy will be unfairly aroused, resulting in a

disproportionate award of damages.” Ermini v. Scott, 937

F.3d 1329, 1340 (11th Cir. 2019) (quoting Burrage v.

Harrell, 537 F.2d 837, 839 (5th Cir. 1976)).

Jackson asserts that two portions of the

Government’s closing argument violated this precept. In

suggesting that every patient would prefer a sterile device

to an adulterated one, the Government asked, “Which one

would you want? .... If you could have a device that had

been here fully coated and contaminated with another

person’s blood and mucous, or you could have that

perfectly pristine device, which one would you want?

Which one would you choose?” J.A. 3418. The Government

then “add[ed] another factor to [the juror’s] choice,”

observing that the unused device was “completely sterile”

and posed “zero risk that another human’s bodily fluids

would get inside your body .... Would that impact your

decision?” J.A. 3418.

39

Assuming, without deciding, that these statements

constitute an impermissible “Golden Rule” argument, we

conclude that they were not prejudicial in context and

therefore do not require reversal. We will reverse a

conviction based on an improper closing argument only

when the impropriety “so prejudicially impacted the

defendant’s substantial rights as to deprive him of a fair

trial.” United States v. Webb, 965 F.3d 262,

267 (4th Cir. 2020) (quotations and citation omitted). And

here our review is further constrained by the plain-error

standard

because

Jackson

neither

lodged

a

contemporaneous objection nor moved for judgment of

acquittal on this ground in the district court. 15 See id.

Jackson has not met her burden. The allegedly

improper argument consists of three lines in a closing

argument that spans some thirteen pages devoted just to

Count 1. Quite apart from these brief references, the jury

had overwhelming evidence supporting Jackson’s

culpability. Indeed, Jackson admitted to reusing

Entelluses, and it’s undisputed that she did not inform her

patients that she did so. Other evidence supported the

jury’s conclusion that Jackson’s re-use and cleaning

methods nonetheless “adulterated” the device. And still

more evidence supported the jury’s finding that by reusing

the devices, Jackson profited by billing Medicare in full for

the sinuplasty procedure that factored in

the full price of a new device. Jackson profited

handsomely from her approach. On this record, we cannot

discern that Jackson’s substantial rights were impacted

and, absent that showing of prejudice, reversal is not

warranted. See Huskey, 90 F.4th at 671.

&

40

Having rejected each of Jackson’s arguments as to

Count I, we affirm her conviction for violating 21 U.S.C.

§ 331(k).16

III.

Jackson next challenges her convictions for

aggravated identity theft, in violation of 18 U.S.C. §§

1028A(a)(l) and 2, which formed Counts 15 and 16 of the

superseding indictment. This offense imposes a

mandatory consecutive two-year term of imprisonment

if an individual has been convicted of other qualifying

offenses and, during or in relation to those offenses, the

defendant “knowingly transfers, possesses, or uses,

without lawful authority, a means of identification of

another person.” § 1028A(a)(l), (b)(2); see United

States v. Abdelshafi, 592 F.3d 602, 607 (4th Cir. 2010)

(recounting the four elements of

this offense).

The superseding indictment charged that Jackson

aided and abetted in aggravated identity theft by

manufacturing backdated declarations purporting to be

from two patients, using their names and, most

importantly, their forged signatures. Jackson then

submitted those declarations as part of her responses to

the 2018 Palmetto audit.

After the jury convicted Jackson, the Supreme

Court decided Dubin v. United States, 599 U.S. 110

(2023), which clarified what it meant to “use” an

individual’s identity “in relation to” another qualifying

41

offense. Arguing that Dubin invalidated her convictions,

Jackson moved for a judgment of acquittal or a new trial

as to Counts 15 and 16. The district court denied her

motion. It concluded that the concerns present in Dubin

about when a defendant’s “use” of another’s identifying

information is sufficiently close to the qualifying offense

to be deemed “in relation to” to it were not at issue in this

case. In the court’s view, the requisite hook between the

identity theft and qualifying other offense existed here

because Jackson had forged the patients’ signatures on

declarations purporting to be from those patients and

then submitted them as part of the false statements that

constituted the qualifying other offense (making false

statements relating to health care matters).

On appeal, Jackson does not challenge the denial of

her motion for judgment of acquittal. Instead, she relies

on Dubin to make two different arguments: that Dubin

rendered the superseding indictment and the jury

instructions deficient because it requires a specific

finding—by the grand jury and the petit jury,

respectively—that the alleged misuse of the victim’s

identity was what made the qualifying offense criminal.

Because the grand jury did not so find as part of Counts

15 or 16, she contends the Court should vacate those

convictions and remand for the district court to dismiss

those charges. Alternatively, because the jury instructions

did not require the jury to make this finding before

convicting her, she asserts the Court should vacate those

convictions and remand to permit a new trial.

Because Jackson .did not raise either of these

challenges in the district court, we review for plain error.

42

See Greer v. United States, 593 U.S. 503, 507-08 (2021). 17

Jackson has not met her burden of showing any error, let

alone an obvious.one.

* In Dubin, the Supreme Court “clarified the scope of

the statute prohibiting aggravated identity theft? by

resolving a circuit'split (which we were not,part of) about

when a defendant “uses” another’s identifying information

“in relation to” another qualifying offense. United States

i). . O’Lear, 90 F.4th 519, ’532-33 (6th Cir. 2024). The

defendant in Dub in conducted certain psychological tests

on a patient and then-submitted

claims to Medicaid for reimbursement. Dubin, 599 U.S. at

114.-That paperwork referred to the patient by name and

described < the: procedures performed, but fraudulently

inflated the amount to be reimbursed’by misrepresenting

the ■qualifications of the person .performing the

procedures. >Id. Unlike this, case, the patient’s signature

did-not appear on the paperwork. And while the patient’s

name appeared on the*provider-submitted paperwork,

services had been performed on that named patient. Id.

The provider’s “fraud” thus related to,identifying the type

and dates of services identified for reimbursement, not the

identity; or existence of.any.particular patient.

The Government charged the. Dubin defendant

with aggravated identity theft based on the. submitted

paperwork* bearing the name of the patient. Id. at 114-15.

But the Supreme-Court held’that §’1028A(a)(l) does not

cover such conduct, observing identity theft offenses occur

“when the defendant’s misuse of another .person’s means

of identification is at the crux of what makes the conduct

criminal,” i.e., when the means of identification

44

Nor do we discern any reason to believe that Dubin

undercuts the factual basis on which Jackson was charged

or convicted. The “crux” of Jackson’s fraud was in

submitting falsified paperwork as part of a Medicaid

audit. But crucially, for § 1028A purposes, that falsified

paperwork contained the two declarations that then

formed the basis of the aggravated identity theft counts.

And “who” created and signed those declarations was

essential to the qualifying offense’s fraud—Jackson

submitted them claiming that they were declarations

signed by her patients supporting what they represented

and thus supporting her responses to the audit. Instead,

the declarations were not the patients’ representations at

all, nor did they bear the patients’ real signatures. Rather,

it was Jackson (or those under her direction) who both

crafted the declarations purporting to be from her patients

and attested to those representations by forging the

patients’ signatures.

Thus, unlike the circumstances in Dubin, the

circumstances here present a classic case of identity theft,

falling cleanly within the aggravated identity theft

statute’s scope. At bottom, the facts in Dubin differ

significantly from this case, and the concerns the Supreme

Court targeted there are not implicated here. See, e.g.,

United States v. Gladden, 78 F.4th 1232, 1245 (11th Cir.

2023) (concluding that no Dubin-like mismatch existed

where the defendant used others’ identities “to continue

refilling prescriptions in their names,” making that

forgery “the heart of’ the fraudulent practice of billing for

medically unnecessary prescriptions). We reject Jackson’s

contention that the indictment or instructions were

deficient in view of Dubin’s clarifying language about the

scope of the

offense. Discerning no error—plain or otherwise—with

Jackson’s convictions for aggravated identity theft

(Counts 15 and 16), we affirm them.

45

IV. .

For the reasons set forth above, we affirm all of

Jackson’s convictions.

AFFIRMED

46

APPENDIX B

FILED: March 4, 2025

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

No. 23-4467 (L) (5:21-cr-00259-D-l)

UNITED STATES OF AMERICA Plaintiff Appellee

v.

ANITA LOUISE JACKSON Defendant Appellant

........................

PHYSICIANS AGAINST ABUSE, INC. Amicus

Supporting Appellant

No. 23-4587 (5:21-cr-00259-D-l)

UNITED STATES OF AMERICA Plaintiff - Appellee v.

ANITA LOUISE JACKSON

Defendant - Appellant---------- ------------------PHYSICIANS AGAINST ABUSE, INC. Amicus

Supporting Appellant

___________________ORDER

The court denies the petition for rehearing and rehearing

en banc. No judge requested a poll under Fed. R. App. P.

40 on the petition for rehearing en banc.

Entered at the direction of the panel: Chief Judge Diaz,

Judge Agee, and Judge Benjamin.

For the Court

/s/ Nwamaka Anowi, Clerk

47

APPENDIX C

Frequently-Asked-Questions

about

the

Reprocessing and Reuse of Single-Use Devices by

Third-Party and Hospital Reprocessors; Final

Guidance for Industry and FDA Staff Document

issued on July 6, 2001

This document supersedes Frequently-Asked-Questions

about the Reprocessing and Reuse of Single-Use Devices

by Third Party and Hospital Reprocessors; Final

Guidance for Industry and FDA Staff, May 27, 2001.

U.S. Department Of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of Health and Industry Programs

Div. of Device User Programs and Systems Analysis

Preface

Public Comment

Comments and suggestions may be submitted at any time

for Agency consideration to Dockets Management Branch,

Division of Management Systems and Policy, Office of

Human Resources and Management Services, Food and

Drug Administration, 5630 Fishers Lane, Room 1061,

(HFA-305), Rockville, MD, 20852. When submitting

comments, please refer to the exact title of this guidance

document. Comments may not be acted upon by the

Agency until the document is next revised or

updated.

Additional Copies

Additional copies are available from the Internet at

48

(http ://www. fda. gov/cdrh/ohip/guidance/1333.p df).

You

may

also

send an e-mail request to

dsmica@fda.hhs.gov to receive an electronic copy of the

guidance or send a fax request to 301-847-8149 to receive

a hard copy. Please use the document number (1333) to

identify the guidance you are requesting.

Frequently-Asked-Questions about the Reprocessing and

Reuse of Single-Use Devices by Third-Party and Hospital

Reprocessors; Final Guidance for Industry and FDA Staff

This document is intended to provide guidance. It

represents the Agency’s current thinking on this topic. It

does not create or confer any rights for or on any person

and does not operate to bind the Food and Drug

Administration (FDA) or the public. An alternative

approach may be used if such approach satisfies the

requirements of the applicable statute and regulations.

Background

On August 14, 2000, the Food and Drug Administration

released a document entitled “Enforcement Priorities for

Single-Use Devices Reprocessed by Third Parties and

Hospitals” to provide guidance to third-party and

hospitals reprocessors about their responsibilities as

manufacturers engaged in reprocessing devices labeled

for single use under the Federal Food, Drug, and Cosmetic

Act (the Act), as amended by the Safe Medical Devices Act

of 1990, the Medical Device Amendments of 1992, and the

Food and Drug Modernization Act of 1997. Third-party

and hospital reprocessors of single-use devices (SUDs) are

subject to all the regulatory requirements currently

applicable to original equipment manufacturers,

including premarket submission

49

requirements (Section 513 and 515 of the Act; 21 Code

of Federal Regulations Parts 807 and 814).

Since its release on August 14, 2000, the agency has

received numerous questions about the enforcement

priorities guidance. The following questions and answers

are meant as clarification of the original document. This

guidance will be updated as the need arises. The Least

Burdensome Approach We believe FDA should consider

the least burdensome approach in all areas of medical

device regulation. This guidance reflects our careful

review of the relevant scientific and legal requirements

and what we believe is the least burdensome way for you

to comply with those requirements. However, if

you believe that an alternative approach would be less

burdensome, please contact us so we can consider your

point of view. You may send your written comments to the

contact person listed in the preface to this guidance or to

the CDRH Ombudsman. Comprehensive information on

CDRH's Ombudsman, including ways to contact him, can

be found on the Internet at

http://www.fda.gOv/cdrh/resolvingdisputes/ombudsman.h

tml.

Question related to SELECTION OF A THIRDPARTY REPROCESSOR

Question. How can 1 obtain information about thirdparty reprocessors of single-use devices

(SUDs)?

Answer. At this time, FDA cannot provide a list of

reprocessors because our registration and listing

database was not designed to identify third-party

reprocessors. We plan to create a specific code that

will identify reprocessors.

50

To help you select a third-party reprocessor, we suggest

you talk with other hospitals to determine their

experiences with third-party reprocessors and arrange to

visit the reprocessors’ facilities. In addition, you may

consider asking a potential reprocessor the following

questions:

• When did FDA last inspect your facility? What were the

results of that inspection?

• Do you have documentation that demonstrates that

your company has been cleared/approved by FDA to

reprocess SUDs?

• How do you monitor the manufacturing processes and

what records do you maintain in order to comply with

FDA's Quality System regulation?

• What aspects of your overall process have been

validated, for example, cleaning, packaging,

sterilization?

• Has your company set limits on the number of times a

SUD can be reprocessed? If yes, how did you determine

the number of times a SUD can be reprocessed? What

procedures do you have in place to ensure that a SUD is

not reprocessed beyond the set number of times?

To obtain the 483 inspection report from a reprocessor’s

most recent FDA inspection, contact FDA's

Freedom of Information Staff by fax at 301-443-1719 or

301-443-1726. You also can obtain information about a

reprocessor’s

inspection

history

at

http ://www. fda. gov/cdrh/foicdrh. html.

Question related to

MEDICAL DEVICE REPORTING

Question. What are FDA's requirements for reporting an

adverse event with a SUD reprocessed

by the hospital1?

51

Answer. If a hospital reprocesses a device that was

previously marketed as a single-use device, FDA

considers the hospital to be the manufacturer of that

device and subject to the same adverse event

reporting requirements (Medical Device Reporting or

"MDR") as original equipment manufacturers or

commercial reprocessors. A manufacturer is defined in

Title 21 of the Code of Federal Regulations (CFR) at

803.3(d) as "any person who manufactures, prepares,

propa-gates, compounds, assembles, or processes a device

by chemical, physical, biological, or other procedure." The

manufacturer MDR requirements are in addition to the

hospital's current user facility adverse event reporting

requirements. Information on MDR requirements is

available

on

the

Internet

at

http ://www. fda. gov/cdrh/mdr. html and

http://www.fda.gov/cdrh/osb/guidance/1334.pdf.

Questions related to QUALITY SYSTEM

GENERAL

Question. Should my hospital comply with the Quality

System regulation even if the SUDs that we are

reprocessing do not require premarket submissions to the

FDA?

Answer. Yes. Regardless of whether or not the SUDs that

your hospital is reprocessing require premarket

submissions, your hospital should comply with the

requirements of the Quality System regulation [which

also is referred to as the current Good Manufacturing

Practice ( cGMP)] as described in 21 CFR Part 820 (see

Appendix question #7 below). The following Internet web

sites provide information about the requirements of the

regulation:

http://www.FDA.gov/CDRH/dsma/gmpman.html -

52

Medical Device Quality Systems Manual:

A Small Entity Compliance Guide

http://www.FDA.gov/CDRH/comp/designgd.html - Design

Control Guidance for Medical Device Manufacturers

http ://www. FDA. gov/ora/inspect_ref/igs/qsit/qsitguide ,p df

- Quality System Inspection Technique (QSIT) Handbook

http://www.FDA.gov/CDRH/ode/425.pdf - Guideline on

General Principles of Process Validation

Question. Is the CEO of a hospital responsible for quality

policy and implementation under the

Quality System (QS) regulation?

Answer. Under 21 CFR 820.20 (Management

responsibility) management with executive responsibility

is the level of management that has the authority to

establish and make changes to the facility’s quality policy.

The implementation of the quality system may be

delegated; however, it is up to the highest level of

management to establish quality policy and ensure

implementation. Management reinforces understanding

of policies and objectives by demonstrating a commitment

to the quality system visibly and actively on a continuous

basis. This can be demonstrated by providing adequate

training and resources to support quality system

development and implementation.

STERILIZATION

Question. What sterilization activities does FDA expect in

a hospital reprocessor that is

reprocessing single-use devices (SUDs)?

53

Answer. A hospital reprocessor that reprocesses SUDs is

considered a device manufacturer as defined under 21

CFR 820.3(o). As such, FDA expects that its sterilization

reprocessing of SUDs will meet the requirements of the

Quality System (QS) regulation (21 CFR Part 820). This

regulation is applicable to the sterilization activities in

many ways. Several key elements affect whether a device

is sterile or nonsterile and whether it will function as

intended at the conclusion of the process. The success of a

sterilization process is dependent to a large degree on how

well the hospital reprocessor:

• has validated the sterilizing equipment and process;

• controls the routine processing; and

• reaches decisions to assure that only a sterile product is

released for use.

A hospital SUD reprocessor should prove during

validation studies that each sterilization process is

capable of achieving sterility for each run (21 CFR

820.75). The sterilization process should achieve a

sterility assurance level (SAL) of 10 -6 for devices used in

normally sterile areas of the body. A hospital reprocessor

cannot just assume that standard sterilizer cycles will

effectively and safely reprocess devices; it should

demonstrate with microbiological lethality study data

that the SAL is achieved by the process utilized. Also, a

hospital reprocessor should develop evidence that the

sterilization process does not have an adverse impact on

the materials or functioning of the SUDs being

reprocessed.

Process controls used for routine sterilization should be

adequate to assure that the specifications for process

54

parameters established during validation are always met

[21 CFR 820.70(2)]. By doing validation studies, a

hospital reprocessor can prove that when certain

parameters (for example, temperature or humidity) are

used, sterility will be achieved. A hospital reprocessor

should establish controls over the routine processing to

assure that the specifications for these parameters are

met during each run.

Finally, a hospital reprocessor should have procedures for

releasing the SUDs for use, so that any possibly nonsterile reprocesssed SUD is detectable [21 CFR 820.80(d)].

It should review documentation from each run to be sure

that the parameter specifications have been met. Many

hospital reprocessors also include biological confirmation

of sterility by using biological indicators ( Bls) with each

run. While FDA strongly encourages the use of biological

indicators, there may be circumstances when the

validation studies and the process controls are so rigorous

that Bls might not be needed. In these cases, the process

should meet the parametric releases that are defined in

recognized consensus standards.

Question. What kinds of documentation should a

hospital reprocessor maintain for sterilization

reprocessing of SUDs? Answer. A hospital that

reprocesses SUDs should maintain written procedures

and data to show that it is meeting requirements of

relevant portions of the Quality System (QS) regulation

(21 CFR Part 820).

In the area of sterilization, a hospital reprocessor should

maintain documentation to show that equipment

55

has been installed correctly and operates as intended.

Likewise, it should have documentation that shows the

sterilization process has been validated as being effective

in achieving sterility without adversely affecting the

devices [21 CFR 820.75(a)]. Also, a hospital reprocessor

should maintain documentation for process control

procedures and data to prove that for each run the

specifications for sterilization parameters have been met

[21CFR 820.70(a) and 820.184], FDA may also ask to see

any test results relating to the validation or routine

sterilization of SUDs.

Question. What guidance is applicable to hospital

reprocessors that are sterilizing SUDs?

Answer. FDA has guidance documents that apply

generally to all types of manufacturing processes

including sterilization. For example, the “Guideline on

General Principles of Process Validation” applies

to sterilization activities as well as to other

manufacturing processes. This document is located on the

Internet

at

www.fda.gov/cdrh/ode/425.pdf.

FDA

documents relating to the Quality System (QS)

regulation also are applicable for sterilization processes.

These documents are located on the Internet at

www.fda.gov/cdrh/dsma/cgmphome.html.

General

guidance is available from other sources such as the

Global Harmonization Task Force document entitled

"Process Validation Guidance for Medical Device

Manufacturers." Many national and international

consensus standards provide specific sterilization

processes. We encourage you to become familiar with

these standards. FDA has worked closely with other

experts from industry, healthcare facilities, and academia

in developing these standards for the various

56

types of sterilization processes commonly used for medical

devices. FDA recognizes many of these standards as

providing acceptable guidance for good sterilization

practices. Although acceptable to FDA, these standards

are Voluntary, and there is no regulatory requirement

that they be followed. If these standards

are not followed, FDA expects that processing will meet

the same levels of scientific soundness as the standards.

The FDA consensus standards program is described on

the Internet at www.fda.gov/cdrh/stdsprog.html. A list of

standards useful in the reprocessing sterilization of SUDs

is

located

at

www.fda.gov/cdrh/reuse/reusestandards.shtml . Although consensus standards for the

sterilization of medical devices have been directed either

to healthcare facilities or to industrial users,

many are being rewritten to include both types of

facilities. For example, in the area of sterilization

methods commonly used in hospitals (moist heat or

ethylene oxide), there are standards for both

industrial users and for healthcare facilities, as follows:

STERILIZATION

METHOD

INDUSTRIAL

FACILITY USE

HEALTHCARE

FACILITY USE

ETHYLENE OXIDE

ISO 11135

ANSI/AAMI ST 41

MOIST HEAT

ISO 11134

ANSI/AAMI ST 46

Note that ANSI/AAMI ST 41 states that it does not cover

the reprocessing of

items labeled for single-use only. Revisions of ANSI/AAMI

ST 46 have been written and indicate a similar exclusion

for reprocessing of SUDs.

When deciding which standards to use for sterilization of

SUDs, remember that FDA considers hospitals to be

58

be reprocessed safely. In fact, such a list would be

impossible to develop. Whether or not a device can be

reprocessed safely depends not only on the device but on

the reprocessor and the methods used for cleaning and

sterilizing. Because of materials used or design of the

device, some models within a particular type of device may

be able to be reprocessed safely while others may not.

Question. If a device is identified as "Exempt" on the List

of SUDs (Appendix A), is it exempt from both premarket

and non-premarket requirements?

Answer. No. A "Y" (yes) in the column identified as

"Exempt (Y/N)?" means that the device is exempt

from the premarket requirements only. It does not provide

any information on whether or not the

device is exempt from any of the non- premarket

regulatory requirements. A revised list that includes a

column titled "Premarket Exempt" and another column

titled "GMP Exempt" has been provided to clarify the

types of exemptions that apply to a particular type of

device. That list can be found on the Internet at

www.fda.gov/cdrh/reuse/1168a.html.

Questions related to

SPECIFIC DEVICES

Question. Where can I obtain specific guidance for the

SUD that I am interested in

reprocessing?

Answer. You can search for guidance on a specific device

on our Internet web site at

59

http ://www. fda. gov/cdrh/guidance. html

http ://www.fda. gov/cdrh/devadvice/11. html.

and

Question. How can I obtain information on the status of

a premarket notification [510(k)] submission or a

premarket approval (PMA) application'for a reprocessed

SUD?

Answer. The status of an application under FDA review

is confidential. Once an application has been cleared or

approved, it is included in FDA's releasable database on

the Internet at http://www.fda.gov/cdrh/databases.html.

Click on the Premarket Notifications Database [510(k)s]

or the Premarket Approvals Database (PMA).

Question related to

REGISTRATION AND DEVICE LISTING

Question. How do we register our facility and list the

SUDs that we are reprocessing?

Answer. A medical device establishment that is

registering for the first time should complete form FDA

2891 (Initial Registration of Device Establishment). Enter

the establishment type code "MB" for a reprocessor if the

form you receive does not have the code preprinted on it.

You should list all SUDs that your facility reprocesses.

Submit a form FDA 2892 (Device Listing) for each type of

device being reprocessed. Information on how to obtain

blank registration and listing forms and how to complete

them

is

located

on

the

Internet

at

http://www.fda.gov/cdrh/reglistpage.html .

Note: Additional Questions are available at:

http://www.fda.gov/cdrh/ohip/guidance/1408.html