Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 40061 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Jarrod Collier 

at ctgtac@fda.hhs.gov (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15783 Filed 7–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–Z–0025] 

Medical Devices; Class I Surgeon’s 

and Patient Examination Gloves 

AGENCY: Department of Health and 

Human Services (HHS), Food and Drug 

Administration (FDA). 

ACTION: Final order, determination. 

SUMMARY: The Department of Health and 

Human Services (HHS or ‘‘the 

Department’’) issued a Notice in the 

Federal Register of January 15, 2021, 

(‘‘the January 15 notice’’) which 

identified seven types of reserved class 

I devices that the Department had 

determined no longer require premarket 

notification. The Department and the 

Food and Drug Administration (FDA or 

‘‘the Agency’’) issued a Notice in the 

Federal Register of April 16, 2021 (‘‘the 

April 16 notice’’) explaining the basis 

for our current view that the seven types 

of reserved class I devices identified in 

the January 15 notice require a 

premarket notification, and explaining 

why the reasoning supporting the prior 

determination was unsound. HHS and 

FDA sought comment on the matters 

discussed in the April 16 notice, and 

have considered the comments that 

were submitted to the docket. HHS and 

FDA are issuing this final order and 

determination that the seven types of 

class I surgeon’s gloves and patient 

examination gloves listed in the January 

15 notice are reserved class I devices for 

which a premarket notification is 

required. 

DATES: Compliance date: All devices 

subject to this order shall comply with 

the order no later than August 25, 2021. 

ADDRESSES: For access to the docket to 

read background documents or the 

electronic and-written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Angela Krueger, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1660, Silver Spring, 

MD 20993, 301–796–6380, or by email 

at RPG@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background Regarding Section 510(l) 

of the FD&C Act 

Under section 513 of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 360c), FDA must classify 

devices into one of three regulatory 

classes: Class I, class II, or class III. FDA 

classification of a device is determined 

by the amount of regulation necessary to 

provide a reasonable assurance of safety 

and effectiveness. The Medical Device 

Amendments of 1976 (‘‘1976 

amendments’’) (Pub. L. 94–295), and the 

Safe Medical Devices Act of 1990 (Pub. 

L. 101–629), require FDA to classify 

devices into class I (‘‘general controls’’) 

if there is information showing that the 

general controls of the FD&C Act are 

sufficient to assure safety and 

effectiveness; into class II (‘‘special 

controls’’), if general controls, by 

themselves, are insufficient to provide 

reasonable assurance of safety and 

effectiveness, but there is sufficient 

information to establish special controls 

to provide such assurance; and into 

class III (premarket approval), if there is 

insufficient information to support 

classifying a device into class I or class 

II and the device is a life sustaining or 

life supporting device, or is for a use 

which is of substantial importance in 

preventing impairment of human 

health, or presents a potential 

unreasonable risk of illness or injury. 

Unless a device is exempt from 

premarket notification, section 510(k) of 

the FD&C Act (21 U.S.C. 360(k)) and the 

implementing regulations, part 807 of 

Title 21 of the Code of Federal 

Regulations (CFR), require persons who 

intend to market a new device to submit 

a premarket notification (510(k)) 

demonstrating the new device is 

‘‘substantially equivalent’’ within the 

meaning of section 513(i) of the FD&C 

Act to a legally marketed device for 

which premarket approval is not 

required. Section 510(l)(1) of the FD&C 

Act, added to the statute by the Food 

and Drug Administration Modernization 

Act of 1997 (FDAMA), provides that a 

510(k) is not required for a class I 

device, except for any class I device 

intended for a use that is of substantial 

importance in preventing impairment of 

human health, or any class I device that 

presents a potential unreasonable risk of 

illness or injury. FDA refers to these as 

the ‘‘reserved criteria’’ and to class I 

devices subject to 510(k) as ‘‘class I 

reserved devices.’’ Thus, class I devices 

are exempt from the 510(k) 

requirements except for class I device 

types that meet the reserved criteria 

under section 510(l)(1). 

As discussed in the April 16 notice, 

since 2017, FDA has evaluated which 

devices meet the reserved criteria 

several times. See 86 FR 20167 at 20168. 

Each time, FDA has made its 

determinations available to the public 

through publication in the Federal 

Register. See 63 FR 5387, 63 FR 63222, 

65 FR 2296, 82 FR 17841, 84 FR 71794. 

In 1998, after FDAMA was enacted, 

FDA evaluated all class I devices in 

interstate commerce at that time, and 

published a notice in the Federal 

Register containing: (1) A list of device 

types that FDA believed met the 

reserved criteria and thus would remain 

subject to premarket notification and (2) 

a list of device types that FDA believed 

did not meet these criteria and thus 

would be exempt from such 

requirements. See 63 FR 5387. Although 

devices that did not meet the reserved 

criteria became exempt on February 19, 

1998, FDA also issued proposed and 

final rules amending the applicable 

classification regulations for these 

devices, as well as for five device types 

that FDA had exempted prior to 

FDAMA that, post-FDAMA, FDA 

determined meet the reserved criteria. 

See 63 FR 63222, 65 FR 2296. 

On December 13, 2016, the 21st 

Century Cures Act (Cures Act) amended 

section 510(l) of the FD&C Act, 

reorganizing section 510(l) into 

paragraphs 510(l)(1) and (2). Section 

510(l)(2) of the FD&C Act requires FDA 

to identify at least once every 5 years, 

through publication in the Federal 

Register, any type of class I device that 

the Agency determines no longer 

requires a report under section 510(k) of 

the FD&C Act to provide reasonable 

assurance of safety and effectiveness. 


jbell on DSKJLSW7X2PROD with NOTICES
40062 Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 

Section 510(l)(2) of the FD&C Act 

further provides that, upon publication 

of the Agency’s determination in the 

Federal Register, these devices shall be 

exempt from 510(k), and the 

classification regulation applicable to 

each such type of device shall be 

deemed amended to incorporate such 

exemption. Accordingly, in 2017, FDA 

published in a notice in the Federal 

Register a list of class I device types that 

it has determined no longer meet the 

reserved criteria and are thus exempt 

from 510(k) (82 FR 17841). In 2019, FDA 

amended the classification regulations 

to reflect its exemption determinations. 

II. Criteria for Exemption From Section 

510(k) of the FD&C Act 

Section 510(l)(1) of the FD&C Act 

provides that a class I device is not 

exempt from the premarket notification 

requirements of section 510(k) of the 

FD&C Act if the device is intended for 

a use that is of substantial importance 

in preventing impairment of human 

health, or it presents a potential 

unreasonable risk of illness or injury. As 

explained in the April 16 notice, section 

510(l)(2) of the FD&C Act directs FDA to 

identify which class I devices that FDA 

previously determined meet the 

reserved criteria no longer meet these 

criteria, in which case a 510(k) is no 

longer required to provide reasonable 

assurance of safety and effectiveness. 

FDA has explained that in determining 

whether either of these criteria are met, 

the Agency considers, for example, its 

experience in reviewing premarket 

notifications for each device, focusing 

on the risk inherent with the device and 

the disease being treated or diagnosed 

(e.g., devices with rapidly evolving 

technology or expansions of intended 

uses). See 63 FR 5387, 82 FR 17841. The 

Agency also considers the history of 

adverse event reports under the medical 

device reporting program for these 

devices, as well as their history of 

product recalls. Id. 

As discussed in the April 16 notice, 

the January 15 notice (86 FR 4088) 

neither discussed the reserved criteria 

nor explained how HHS came to 

determine that the gloves no longer 

meet the reserved criteria; i.e., that the 

gloves are not intended for a use that is 

of substantial importance in preventing 

impairment of human health, or do not 

present a potential unreasonable risk of 

illness or injury. The January 15 notice 

contained no mention of or cite to this 

statutory standard, nor an explanation 

as to why it was left out. The April 16 

notice discussed other procedural and 

substantive deficiencies in the January 

15 notice that contributed to HHS’s and 

FDA’s decision to reverse the 

determinations made in that notice. For 

example, the January 15 notice relied 

solely upon adverse event reports in the 

Manufacturer and User Facility Device 

Experience (MAUDE) as its basis for 

determining the products to be exempt 

from 510(k), and then only adverse 

event reports for a very narrow period 

of time. While adverse event reports are 

a valuable source of information, the 

reports have limitations, including the 

potential submission of incomplete, 

inaccurate, untimely, unverified, or 

biased data. In addition, the incidence 

or prevalence of an event cannot be 

determined from adverse event reports 

alone, due to underreporting of events, 

inaccuracies in reports, lack of 

verification that the device caused the 

reported event, and lack of information 

about frequency of device use. Adverse 

event data is not adequate on its own for 

assessing safety, let alone whether to 

determine a device to be exempt from 

510(k). 

III. Final Order Regarding Surgeon’s 

Gloves and Patient Examination Gloves 

and Premarket Notification 

In the April 16 notice, HHS and FDA 

announced our view that surgeon’s 

gloves and patient examination gloves 

meet the reserved criteria, and sought 

comment on this determination. HHS 

and FDA received eight comments on 

that notice, all of which were supportive 

of the determination that surgeon’s 

gloves and patient examination gloves 

meet the reserved criteria and are 

properly subject to premarket 

notification. 

As discussed in the April 16 notice, 

because of their importance in 

preventing impairment of human 

health, FDA has long considered 

surgeon’s and patient examination 

gloves to meet the reserved criteria 

under section 510(l) and to be subject to 

the 510(k) requirement. See 63 FR 5387, 

63 FR 63222, 65 FR 2296. In 2017 and 

2019, FDA evaluated all class I reserved 

devices to determine whether they 

continued to meet the reserved criteria. 

See 82 FR 17841, 84 FR 71794. FDA 

specifically evaluated the seven device 

types at issue based on its experiences 

with 510(k) submissions for the gloves, 

the risk inherent to the devices and the 

diseases they prevent, and other 

relevant considerations and determined 

that surgeon’s gloves and patient 

examination gloves met the reserved 

criteria and therefore remained subject 

to premarket notification. 

HHS and FDA continue to believe that 

these gloves are of substantial 

importance in preventing impairment of 

human health or present a potential 

unreasonable risk of illness or injury 

and thus are subject to the reporting 

requirement under section 510(k) of the 

FD&C Act. Based on the risks inherent 

to surgeon’s gloves and patient 

examination gloves and the diseases 

being prevented, FDA’s experience with 

these devices, and other relevant 

considerations, HHS and FDA have 

determined that gloves with the product 

codes LYY, LYZ, OIG, OPC, OPH, LZC, 

and OPA are intended for uses which 

are of substantial importance in 

preventing impairment of human health 

or present a potential unreasonable risk 

of illness or injury, and thus a report is 

required under section 510(k) of the 

FD&C Act. Surgeon’s gloves and patient 

examination gloves are generally 

intended to prevent contamination and 

the spread of pathogens, and can be the 

key barrier protecting against spreading 

infection (Refs. 1–3). See 21 CFR 

878.4460 and 880.6250. As set forth in 

the April 16 notice, surgeon’s gloves 

prevent against contamination in the 

operating room (Refs. 4 and 5), medical 

gloves protect against occupational 

exposure, for example, to chemotherapy 

drugs (Refs. 6 and 7), and these gloves 

play an important role in protecting the 

public. Review under section 510(k) is 

necessary to provide reasonable 

assurance of their safety and 

effectiveness, including by helping to 

assure that the identified gloves are 

durable and impermeable, among other 

things. 

Based on this evaluation and 

considering the comments submitted, 

HHS and FDA have made a final 

determination that surgeon’s gloves and 

patient examination gloves meet the 

reserved criteria and therefore are 

subject to premarket notification. 

IV. Further Information for Regulated 

Entities 

The gloves discussed in this notice 

are reserved, and as such, a 510(k) is 

required for them. In general, FDA 

evaluates the dimensional and physical 

properties of the gloves, and nonclinical 

data regarding barrier performance, 

biocompatibility, and residual powders, 

among other information, to support the 

safety and effectiveness of the gloves for 

their intended use. FDA also evaluates 

the indications for use and labeling to 

ensure the devices are appropriately 

labeled, consistent with their intended 

use. For any gloves that are 

distributed—including any gloves that 

are presented for import—after the 

compliance date of this order without 

premarket review, the Agency will 

consider and take appropriate 

enforcement action, taking into account 

the enforcement policy in its Guidance 

for Industry, ‘‘Enforcement Policy for 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 140 / Monday, July 26, 2021 / Notices 40063 

Gowns, Other Apparel, and Gloves 

During the Coronavirus Disease 

(COVID–19) Public Health Emergency; 

Guidance for Industry and Food and 

Drug Administration Staff’’ (Ref. 8). 

V. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

1. *Centers for Disease Control. ‘‘Perspectives 

in Disease Prevention and Health 

Promotion Update: Universal 

Precautions for Prevention of 

Transmission of Human 

Immunodeficiency Virus, Hepatitis B 

Virus, and Other Bloodborne Pathogens 

in Health-Care Settings.’’ Morbidity and 

Mortality Weekly Report 1988; 

37(25):377–388. 

2. World Health Organization. Glove Use 

Information Leaflet. 2009. https://

www.who.int/gpsc/5may/Glove_Use_

Information_Leaflet.pdf. 

3. *Collins, A.S. ‘‘Preventing Health CareAssociated Infections.’’ In: Hughes, R.G., 

editor. Patient Safety and Quality: An 

Evidence-Based Handbook for Nurses. 

Rockville (MD): Agency for Healthcare 

Research and Quality (US); 2008 April. 

Chapter 41. https://

www.ncbi.nlm.nih.gov/books/NBK2683/ 

pdf/Bookshelf_NBK2683.pdf. 

4. Alexander, J. Wesley, Joseph S. Solomkin, 

and Michael J. Edwards (2011). 

‘‘Updated Recommendations for Control 

of Surgical Site Infections,’’ Annals of 

Surgery, 253(6):1082–1093. 

5. Sugarbaker, P.H. (2018). ‘‘Increased Safety 

of Surgical Glove Application: The 

Under/Over Method’’ Annals of the 

Royal College of Surgeons of England, 

100(4):339–340. 

6. Landeck, L., E. Gonzalez, and O.M. Koch. 

‘‘Handling Chemotherapy Drugs—Do 

Medical Gloves Really Protect?’’ 

International Journal of Cancer. 2015 

October 15;137(8):1800–5. doi: 10.1002/ 

ijc.29058. Epub 2014 July 22. PMID: 

24978061 

7. Nalin, M., G. Hug, E. Boeckmans, C. 

Machon, et al. ‘‘Permeation 

Measurement of 27 Chemotherapy Drugs 

After Simulated Dynamic Testing on 15 

Surgical And Examination Gloves: A 

Knowledge Update.’’ Journal of 

Oncology Pharmacy Practice. 2020 Aug 

26:1078155220950423. doi: 10.1177/ 

1078155220950423. Epub ahead of print. 

PMID: 32847481. 

8. *FDA Guidance, ‘‘Enforcement Policy for 

Gown, Other Apparel, and Gloves During 

the Coronavirus Disease (COVID–19) 

Public Health Emergency, Guidance for 

Industry and Food and Drug 

Administration Staff,’’ March 25, 2020, 

available at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/enforcementpolicy-gowns-other-apparel-and-glovesduring-coronavirus-disease-covid-19- 

public-health. 

Dated: July 12, 2021. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

Dated: July 21, 2021. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–15891 Filed 7–23–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2149] 

Jonathan Doyle: Final Debarment 

Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) debarring 

Jonathan Doyle for a period of 5 years 

from importing articles of food or 

offering such articles for importation 

into the United States. FDA bases this 

order on a finding that Mr. Doyle was 

convicted of a felony count under 

Federal law for conduct relating to the 

importation into the United States of an 

article of food. Mr. Doyle was given 

notice of the proposed debarment and 

an opportunity to request a hearing 

within the timeframe prescribed by 

regulation. As of April 8, 2021 (30 days 

after receipt of the notice), Mr. Doyle 

has not responded. Mr. Doyle’s failure 

to respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this matter. 

DATES: This order is applicable July 26, 

2021. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, or at https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, Division of Enforcement 

(ELEM–4029), Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 240–402–8743, or 

at debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(C) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(C)) permits FDA to 

debar an individual from importing an 

article of food or offering such an article 

for import into the United States if FDA 

finds, as required by section 

306(b)(3)(A) of the FD&C Act, that the 

individual has been convicted of a 

felony for conduct relating to the 

importation into the United States of 

any food. 

On October 15, 2020, Mr. Doyle was 

convicted as defined in section 

306(l)(1)(A) of the FD&C Act, in the U.S. 

District Court for the Northern District 

of Texas-Dallas Division, when the court 

accepted Mr. Doyle’s plea of guilty and 

entered judgment against him for the 

offense of conspiracy to introduce 

misbranded food into interstate 

commerce with an intent to defraud and 

mislead in violation of 18 U.S.C. 371 (21 

U.S.C. 331(a) and 21 U.S.C. 333(a)(2)). 

FDA’s finding that the debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for this conviction is as 

follows: As contained in the factual 

re ́sume ́, dated February 15, 2019, in Mr. 

Doyle’s case, he was the President of 

USPlabs, LLC (USP Labs), and owned 45 

percent of the company. USP Labs sold 

dietary supplements. Beginning in or 

around October 2008 and continuing 

until at least in or around August 2014, 

Mr. Doyle engaged in a conspiracy with 

others to import and ship in interstate 

commerce a variety of chemicals for use 

and prospective use in dietary 

supplements with false labeling. To 

further this conspiracy, Mr. Doyle’s 

coconspirators ordered chemicals from 

Chinese chemical sellers to be used as 

ingredients in dietary supplements and 

had them labeled falsely as other food 

substances. USP Labs sold dietary 

supplements called Jack3d and OxyElite 

Pro, both of which originally contained 

a substance called 1,3- 

dimethylamylamine (DMAA), which is 

also known as methylhexaneamine. USP 

Labs imported numerous substances 

intended for human consumption, 

including DMAA, using false and 

fraudulent Certificates of Analysis 

(COA) and other false and fraudulent 

documentation and labeling. At least 

some of the false COAs that USP Labs 


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