4088 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

1 Medtronic, Inc. v. Lohr, 518 U.S. 470, 476 

(1996). 

2 Id. at 476–77. 

2021, will receive a notification about 

an opportunity to participate in the 

public comment session of the meeting. 

If you wish to speak during the public 

comment session, follow the 

instructions in the notification and 

identify which topic(s) you wish to 

address. We will do our best to 

accommodate requests to make public 

comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

comments and request time jointly. All 

requests to make a public comment 

during the meeting must be received by 

March 7, 2021, 11:59 p.m. Eastern Time. 

We will determine the amount of time 

allotted to each commenter, the 

approximate time each comment is to 

begin, and will select and notify 

participants by March 21, 2021. No 

commercial or promotional material 

will be permitted to be presented at the 

public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be held via Adobe Connect webcast: 

https://collaboration.fda.gov/ 

pdufavify21/. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

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

forindustry/userfees/prescription

druguserfee/ucm446608.htm. 

Dated: January 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00831 Filed 1–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

RIN 0991–ZA52 

Making Permanent Regulatory 

Flexibilities Provided During the 

COVID–19 Public Health Emergency by 

Exempting Certain Medical Devices 

From Premarket Notification 

Requirements; Request for 

Information, Research, Analysis, and 

Public Comment on Opportunities for 

Further Science and Evidence-Based 

Reform of Section 510(k) Program 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice; request for information. 

SUMMARY: To provide Americans with 

expanded access to certain medical 

devices to respond to the COVID–19 

Public Health Emergency, FDA issued 

guidance documents providing 

numerous regulatory flexibilities, 

including a temporary waiver of 

premarket notification requirements 

under section 510(k) of the Food, Drug, 

and Cosmetic Act. For seven class I 

devices for which 510(k) premarket 

review as temporarily waived during the 

PHE, the Department of Health and 

Human Services is permanently 

exempting those seven (7) class I 

devices from the 510(k) requirement and 

is also proposing to exempt an 

additional 83 class II devices and 1 

unclassified device class from the 510(k) 

requirement, for which premarket 

review had also been waived during the 

PHE. The Department is soliciting the 

public’s views on whether premarket 

review should be permanently waived 

for some or all of these 83 devices and 

views on ways to improve the 510(k) 

premarket notification program. 

DATES: Part III.A of this Notice shall be 

effective immediately on publication in 

the Federal Register. To be considered, 

responses and comments related to Part 

III.B of this Notice must be received 

electronically, within sixty days of 

publication in the Federal Register as 

provided below. The Department will 

consider information submitted by the 

public in response to Part IV of this 

Notice on a rolling basis, and until 

further notice. 

ADDRESSES: You may submit comments 

through the Federal eRulemaking Portal: 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulatory 

Information Number (RIN) for this 

rulemaking. All comments received will 

be posted to http://regulations.gov, 

including any personal information 

provided. For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov. Comments must 

be identified by 0991–ZA52. Because of 

staff and resource limitations, all 

comments must be submitted 

electronically to www.regulations.gov. 

Follow the ‘‘Submit a comment’’ 

instructions. 

Warning: Do not include any 

personally identifiable information 

(such as name, address, or other contact 

information) or confidential business 

information that you do not want 

publicly disclosed. All comments may 

be posted on the internet and can be 

retrieved by most internet search 

engines. No deletions, modifications, or 

redactions will be made to comments 

received. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including 

personally identifiable or confidential 

business information that is included in 

a comment. You may wish to consider 

limiting the amount of personal 

information that you provide in any 

voluntary public comment submission 

you make. HHS may withhold 

information provided in comments from 

public viewing that it determines may 

impact the privacy of an individual or 

is offensive. For additional information, 

please read the Privacy Act notice that 

is available via the link in the footer of 

http://www.regulations.gov. Follow the 

search instructions on that website to 

view the public comments. 

FOR FURTHER INFORMATION CONTACT: Dan 

Barry, 200 Independence Ave. SW, 

Washington, DC 20201; or by email at 

daniel.barry@hhs.gov; or by telephone 

at 1–877–696–6775. 

SUPPLEMENTARY INFORMATION: The 

Administration is committed to creating 

a data-based regulatory process that 

appropriately balances benefits and 

costs. Consistent with the President’s 

executive order on COVID–19 regulatory 

flexibilities, and Congress’ direction in 

the 21st Century Cures Act, the 

Department is issuing this Notice to 

permanently exempt or proposing to 

permanently exempt certain class I and 

class II medical devices from the 

premarket notification requirement in 

section 510(k) of the Food, Drug, and 

Cosmetic Act, 21 U.S.C. 360(k). Under 

this notice, the Department is 

immediately making permanent the 

exemption of 7 class I device classes 

from the section 510(k) requirement and 

proposes to exempt an additional 84 

class II and unclassified device classes 

from the same requirement on a 

permanent basis. These 91 devices were 

all subject a 510(k) waiving during the 

PHE. 

I. Background 

A. Statutory Framework 

Under the Food, Drug, and Cosmetic 

Act (FD&C Act), medical devices are 

placed ‘‘in three categories based on the 

risk that they pose to the public.’’ 1 Class 

I devices, products ‘‘that present no 

unreasonable risk of illness or injury,’’ 2

are subject to general controls. FD&C 

Act 513(a)(1)(A), 21 U.S.C. 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4089 

3 Lohr, 518 U.S. at 477; see also FD&C Act 

513(a)(1)(B), 21 U.S.C. 360c(a)(1)(B). 

4 Lohr, 518 U.S. at 477. 

5 Id. 

6See 21 CFR 807.97 (providing that 

‘‘determination by the Commissioner that the 

device intended for introduction into commercial 

distribution is substantially equivalent’’ to a 

predicate device ‘‘does not in any way denote 

official approval of the device’’). 

7 Id. 

8 Josh Makower, Aabed Meer & Lyn Denend, FDA 

Impact on U.S. Medical Technology Innovation: A 

Survey of Over 200 Medical Device Companies, at 

7 (Nov. 2010), https://www.medtecheurope.org/wpcontent/uploads/2015/07/01112010_FDA-impacton-US-medical-technology-innovation_

Backgrounder.pdf. During a 2011 hearing before a 

House subcommittee, the Director for the Center for 

Devices and Radiological Health (CDRH) raised 

concerns regarding the methodology used in this 

study. FDA Medical Device Approval: Is There a 

Better Way?, Hearing Before the H. Subcomm. on 

Health Care, District of Columbia, Census and the 

National Archives, 112th Cong. 29 (2011) 

(hereinafter the ‘‘2011 Hearing’’). The CDRH 

Director’s criticisms largely focused on the report’s 

comparison of FDA’s regulation of medical devices 

to the European Union’s regulatory system. The 

CDRH Director otherwise acknowledged that FDA 

does not ‘‘do cost analyses for what the 

manufacturers are doing’’ and that the agency 

‘‘would not know of the total cost to a particular 

company.’’ Id. at 32. Here, the Department is citing 

this study for 510(k) cost and time estimates, not 

for purposes of comparing the U.S. and E.U. 

medical device regulatory systems. 

9 Id. at 22. 

10 Id. at 7. 

11 Id. at 22. 

12 Id. at 29, fig. 10. 

13 Id. 

14Aylin Sertkaya et al., Analytical Framework for 

Examining the Value of Antibacterial Products, at 

5–3 (Apr. 15, 2014). 

15 Id. at 5–4. 

16 40 FR 26142, 26148 (June 20, 1975). 

17 Id. 

360c(a)(1)(A). Class II devices are 

‘‘potentially more harmful’’ than class I 

devices, and ‘‘must comply with federal 

performance regulations known as 

‘special controls.’’’ 3 Class III devices 

carry the highest risk, in that they are 

for ‘‘use in supporting or sustaining 

human life or for a use which is of 

substantial importance in preventing 

impairment of human health, or 

present[ ] a potential unreasonable risk 

of illness or injury.’’ FD&C Act 

513(a)(1)(C)(ii)(I)–(II), 21 U.S.C. 

360c(a)(1)(C)(ii)(I)–(II). 

Medical devices are generally subject 

to FDA premarket review in one of two 

forms. The first is premarket approval 

(PMA) review under section 515 of the 

FD&C Act, 21 U.S.C. 360e. This form of 

‘‘rigorous’’ review, analogous to FDA 

review of a New Drug Application for a 

‘‘new drug,’’ requires manufacturers to 

‘‘submit detailed information regarding 

the safety and efficacy of their devices, 

which the FDA then reviews.’’ 4 During 

the mid-1990s, FDA reported spending 

‘‘an average of 1,200 hours on each 

[PMA] submission,’’ 5 though the time 

for review has likely increased since 

Lohr was decided. 

The second form of premarket review 

is the premarket notification process, 

which is commonly referred to as the 

510(k) process after section 510(k) of the 

FD&C Act, 21 U.S.C. 360(k). Generally, 

under the 510(k) process, a device that 

is ‘‘substantially equivalent’’ to another 

legally marketed predicate device is 

‘‘cleared’’ (as opposed to ‘‘approved’’) 6

by FDA for legal marketing in the 

United States. See FD&C Act 510(k), 

513(i), 21 U.S.C. 360(k), 360c(i). FDA 

regulations specify the required 

contents of 510(k) notifications, 

including labeling, intended use, and 

clinical and performance data 

requirements. 21 CFR 807.92. FDA 

previously reported requiring ‘‘an 

average of only 20 hours’’ to complete 

a 510(k) review,7 which would be 

around 60 times less than the time 

required for PMA review. 

Obtaining either a PMA approval or a 

510(k) clearance to legally market a 

medical device is expensive and timeconsuming. According to a 2010 survey 

of medical device companies, ‘‘the 

average total cost from concept to 

approval [of a PMA device] was 

approximately $94 million, with $75 

million spent on stages linked to the 

FDA.’’ 8 For PMAs, survey respondents 

reported ‘‘that it actually took them an 

average of 54 months to work with the 

FDA from first communication to 

approval.’’ 9

While 510(k) devices trod a swifter, 

less expensive path to market than PMA 

devices do, the same survey found that 

‘‘the average total cost for participants to 

bring a low-to-moderate-risk 510(k) 

product from concept to clearance was 

approximately $31 million, with $24 

million spent on FDA dependent and/or 

related activities.’’ 10 Respondents also 

reported ‘‘an average of 10 months from 

first filing to clearance’’ for a 510(k) 

device.11 The survey authors 

acknowledged that respondents ‘‘were 

most likely those companies working on 

innovative, new medical technologies 

that required clinical data to get through 

the FDA rather those seeking relatively 

simple extensions to low-risk, 

ubiquitous product lines already in 

existence.’’ 12 Nevertheless, the survey 

found the average total cost connected 

to the ‘‘Process of Obtaining [a] 510(k) 

[clearance]’’ to be more than $4 million 

per product.13 Even if these estimates 

overstate costs by a factor of ten, a firm 

could still spend $2.4 million ‘‘on FDA 

dependent and/or related activities,’’ to 

include an estimated $400,000 on the 

510(k) clearance process itself. 

Similarly, even if the survey 

respondents overstated delays, and the 

actual time were much closer to FDA’s 

goal date of 90 days for review, it is 

undisputed that the 510(k) clearance 

process delays a device’s introduction to 

the market. 

A 2014 report on antibacterial 

products produced for the Assistant 

Secretary for Planning and Evaluation 

(ASPE) contains similar findings. The 

report noted that, to conduct a pivotal 

clinical study to support a 510(k) 

submission for a MRSA point-of-care 

diagnostic, a manufacturer could expect 

to spend ‘‘from a low of $250,000 to as 

high as $4.0 million.’’ 14 The report 

estimated the cost to prepare and submit 

a 510(k) application ‘‘at $100,000’’ 

while acknowledging the amount 

‘‘could be highly variable depending on 

device characteristics.’’ 15

These costs are barriers to new market 

entrants. To the extent imposing the 

section 510(k) premarket notification on 

a device does not create corresponding 

safety and efficacy benefits for 

Americans, those barriers are 

unjustified. Such barriers warrant 

scrutiny, particularly when market 

incumbents have an interest in retaining 

them. As FDA acknowledged in a 1975 

proposed rule in the analogous context 

of drug approvals, ‘‘the manufacturer 

who holds the ‘pioneer’ NDA for a drug 

may well have an economic interest in 

retaining the new drug status of that 

drug’’ because ‘‘[a]s long as either a full 

or an abbreviated NDA is required, entry 

into the market place, and thus 

increased competition is impeded.’’ 16

FDA noted its belief ‘‘that it was not the 

intention of Congress that section 505 of 

the [FD&C Act] would be used as an 

economic trade barrier.’’ 17

4090 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

18H.R. Conf. Rep. 105–399, at 96 (1997). 

19FDA, Enforcement Policy for Clinical 

Electronic Thermometers During the Coronavirus 

Disease 2019 (COVID–19) Public Health Emergency, 

at 3 (Apr. 2020), https://www.fda.gov/media/ 

136698/download. 

20 Id. 

21 85 FR 31353, 31356 (May 22, 2020). 

Congress has taken action to ensure 

that the section 510(k) premarket 

notification process does not create 

undue economic barriers for new 

medical devices. Under the FD&C Act, 

the Secretary is authorized to exempt 

class I and II medical devices from the 

510(k) requirement if the Secretary finds 

those devices ‘‘no longer require[ ] a 

report under section [510](k) to provide 

reasonable assurance of safety and 

effectiveness.’’ FD&C Act 510(l)(2), 

510(m)(1)(A)(i), 21 U.S.C. 360(l)(2), 

360(m)(1)(A)(i). Congress did this in 

part to ‘‘allow the Secretary to expend 

limited premarket review resources on 

potentially risky and technologically 

advanced devices’’ so that ‘‘the public 

continues to be adequately protected 

and will still benefit from the earlier 

availability of new products.’’ 18 In 

section 3054 of the 21st Century Cures 

Act, Public Law 114–255, 130 Stat. 

1033, 1126–27 (Dec. 13, 2016), Congress 

imposed additional requirements on the 

Secretary to take action to affirmatively 

review class I and II devices to 

determine whether they are exempt 

from the 510(k) requirement. This 

Notice is responsive to these previous 

mandates. 

B. Waiver of Premarket Notification 

Requirement During COVID–19 PHE 

Beginning in March 2020, in response 

to the COVID–19 Public Health 

Emergency (PHE), FDA issued a series 

of guidance documents designed to 

provide the private sector with 

regulatory flexibility to meet the 

sudden, increased need for personal 

protective equipment, disinfectant 

products, and other devices to combat 

the pandemic. The table below presents 

the various guidance documents issued 

in April 2020 to assist in the response 

to the PHE. 

TABLE 1—LIST OF FDA MEDICAL DEVICE ENFORCEMENT POLICIES RESPONSIVE TO PHE 

Title of guidance Date 

Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 

(COVID–19) Public Health Emergency.

April 2020. 

Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID–19) 

Public Health Emergency.

April 2020. 

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID– 

19) Public Health Emergency (Revised).

May 2020. 

Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease 

(COVID–19) Public Health Emergency.

March 2020. 

Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the 

Coronavirus Disease 2019 (COVID–19) Public Health Emergency.

March 2020. 

Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the 

Coronavirus Disease 2019 (COVID–19) Public Health Emergency.

April 2020. 

Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass 

Devices During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency.

April 2020. 

Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 

(COVID–19) Public Health Emergency.

April 2020. 

Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support 

Patient Monitoring During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency.

April 2020. 

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID–19) Public Health Emergency (Revised).March 2020 (original). 

June 2020 (revised). 

October 2020 (revised). 

Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 

2019 (COVID–19) Public Health Emergency.

April 2020. 

Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the 

Coronavirus Disease 2019 (COVID–19) Public Health Emergency.

April 2020. 

Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the 

Coronavirus Disease 2019 (COVID–19) Public Health Emergency.

March 2020. 

As FDA explained in its clinical 

thermometer guidance, FDA provided 

these flexibilities to ‘‘ensure the 

availability of equipment that might 

offer some benefit to health care 

providers and the general public during 

the public health emergency.’’ 19 To that 

end, among other things, FDA 

announced that the agency ‘‘does not 

intend to object to the distribution and 

use of clinical thermometers that are not 

currently 510(k) cleared.’’ 20 Some of the 

flexibilities, such as those extended to 

remote patient monitoring, have helped 

facilitate telemedicine during the PHE. 

FDA extended similar flexibility to 

additional devices in other guidance 

documents shown in Table 1. 

II. HHS’ Review of 510(k) Premarket 

Notification Flexibilities 

On May 19, 2020, the President issued 

Executive Order No. 13924, instructing 

‘‘[t]he heads of all agencies’’ to ‘‘review 

any regulatory standards that they have 

temporarily rescinded, suspended, 

modified, or waived during the public 

health emergency,’’ in order to 

‘‘determine which, if any, would 

promote economic recovery if made 

permanent.’’ 21 Further, Congress 

already instructed the Secretary to 

consider whether to exempt class I and 

II devices from the section 510(k) 

requirement ‘‘at least once every 5 

years.’’ FDCA 510(l)(2), 510(m)(1)(A), 21 

U.S.C. 360(l)(2), 360(m)(1)(A). 

Consistent with the President’s 

executive order, and Congress’ direction 

in the 21st Century Cures Act, the 

Department conducted a data-driven 

review to determine whether temporary 

waiver of the section 510(k) premarket 

notification requirement for some 

devices during the PHE should be made 

permanent. The flexibilities given by 

FDA during the PHE presented the 

Department with a unique opportunity 

to analyze the adverse event records of 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4091 

22FDA, Product Classification Database, https:// 

www.fda.gov/medical-devices/classify-yourmedical-device/product-code-classificationdatabase. 

23FDA, MAUDE—Manufacturer and User Facility 

Device Experience, https://www.accessdata.fda.gov/ 

scripts/cdrh/cfdocs/cfmaude/search.cfm. 

24 Id. 

25E.g., 85 FR 70003, 70006 (Dec. 20, 2019). 

26See Patrick J. McGrather, The FDA’s MAUDE: 

Useful Insights for Medical Devices (Oct. 31, 2017), 

https://www.americanbar.org/groups/litigation/ 

committees/mass-torts/practice/2017/manufactureand-user-facility-device-experience/. 

27 2011 Hearing at 30. 

28FDA, Manufacturer and User Facility Device 

Experience Database—(MAUDE), https://

www.fda.gov/medical-devices/mandatory-reportingrequirements-manufacturers-importers-and-deviceuser-facilities/manufacturer-and-user-facilitydevice-experience-database-maude. 

devices in periods of time with and 

without the premarket notification 

requirement. In view of this, the 

overarching question for HHS was 

whether premarket notification 

provided corresponding safety and 

efficacy benefits. Below the Department 

describes the methodology for its review 

and the results of the same. 

A. Methodology 

HHS first reviewed the thirteen FDA 

guidance documents listed in Table 1 to 

determine which device types are 

subject to those enforcement policies. 

The Department identified 221 unique 

device types. HHS analyzed those 

device types using FDA’s Product Code 

Database 22 to determine how many of 

those devices require premarket review. 

Of those 221 device types, the 

Department determined that 5 require a 

PMA, 29 are exempt from the 510(k) 

requirement, 3 are marketed subject to 

FDA’s enforcement discretion, and 184 

require 510(k) clearance prior to 

marketing. Of the 184 devices types that 

would require 510(k) clearance without 

the guidance documents list in Table 1, 

10 are class I devices, 173 are class II 

devices, and 1 is unclassified. These 184 

devices are referred to collectively in 

this Notice as the ‘‘Review Devices.’’ 

FDA maintains a publicly available 

adverse event reporting database called 

the Manufacturer and User Facility 

Device Experience database or MAUDE. 

MAUDE ‘‘houses [medical device 

reports or] MDRs submitted to the FDA 

by mandatory reports (manufacturers, 

importers and device user facilities) and 

voluntary reporters such as health care 

professionals, patients and 

consumers.’’ 23 Like any ‘‘passive 

surveillance system,’’ MAUDE has 

‘‘limitations, including the potential 

submission of incomplete, inaccurate, 

untimely, or biased data,’’ which means 

‘‘incidence or prevalence of an event 

cannot be determined from this 

reporting system 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.’’ 24 Even with the system’s 

limitations, MAUDE is an important 

source of data. FDA has previously used 

data from MAUDE to inform the 

agency’s decision making.25 Products 

liability plaintiffs also make use of the 

database.26 As the CDRH Director 

previously explained to Congress, 

systems like MAUDE set the United 

States apart from jurisdictions like the 

European Union that ‘‘do not have 

publicly available centralized data 

base[s] for that kind of information.’’ 27

In this review, the Department 

performed searches of the Review 

Devices in FDA’s online searchable 

MAUDE database. Updated on a 

monthly basis, the online ‘‘searchable 

database data contains the last 10 year’s 

data’’ of reports ‘‘on medical devices 

which may have malfunctioned or 

caused a death or serious injury.’’ 28

HHS entered the three-letter product 

code for each Review Device into the 

online MAUDE database. HHS then 

collected data on the number of reports 

for each Review Device from November 

1, 2010 to November 30, 2020, 

tabulating the reports from November 1, 

2010 to the beginning of the PHE, and 

for the time period subsequent the 

beginning of the PHE to November 30, 

2020. 

B. Results 

Of the 184 Review Devices, HHS 

found there were 120 or more MAUDE 

reports for 74 devices and less than 100 

MAUDE reports for the 110 other 

devices during the last ten years. This 

means roughly 60% of the Review 

Devices have less than 100 MAUDE 

reports over the last ten years. Of those 

110 devices, 35 devices had no MAUDE 

reports from November 1, 2010 to 

November 30, 2020. Those 35 devices 

are shown in Table 2 below. 

TABLE 2—REVIEW DEVICES WITH ZERO ADVERSE EVENT REPORTS IN MAUDE FOR THE TIME PERIOD NOVEMBER 1, 

2010 TO NOVEMBER 30, 2020 

Device description Device class Product 

code 

Section in 

21 CFR 

Powder-Free Polychloroprene Patient Examination Glove .............................................................. I ........................ OPC ....... 880.6250 

Ventilator, Continuous, Minimal Ventilatory Support, Home Use .................................................... II ....................... NQY ....... 868.5895 

Airway Monitoring System ................................................................................................................ II ....................... OQU ....... 868.5730 

Impedance Measuring Device Utilizing Oscillation Techniques ....................................................... II ....................... PNV ....... 868.1840 

Gauge, Pressure, Coronary, Cardiopulmonary Bypass ................................................................... II ....................... DXS ....... 870.4310 

Valve, Pressure Relief, Cardiopulmonary Bypass ........................................................................... II ....................... MNJ ....... 870.4400 

Oximeter, Tissue Saturation, Reprocessed ..................................................................................... II ....................... NMD ....... 870.2700 

Multivariate Vital Signs Index ........................................................................................................... II ....................... PLB ........ 870.2300 

Electrocardiograph Software For Over-The-Counter Use ................................................................ II ....................... QDA ....... 870.2345 

Sterilizer, Dry Heat ........................................................................................................................... II ....................... KMH ....... 880.6870 

Check Valve, Retrograde Flow (In-Line) .......................................................................................... II ....................... MJF ........ 880.5440 

Intravascular Administration Set, Automated Air Removal System ................................................. II ....................... OKL ....... 880.5445 

Neuraxial Administration Set—Intrathecal Delivery ......................................................................... II ....................... PYR ....... 880.5440 

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid ................... II ....................... PSW ....... 892.1570 

Pediatric/Child Facemask ................................................................................................................. II ....................... OXZ ....... 878.4040 

Normalizing Quantitative Electroencephalograph Software ............................................................. II ....................... OLU ....... 882.1400 

Computerized Cognitive Assessment Aid ........................................................................................ II ....................... PKQ ....... 882.1470 

Physiological Signal Based Seizure Monitoring System .................................................................. II ....................... POS ....... 882.1580 

Computerized Behavioral Therapy Device For Psychiatric Disorders ............................................. II ....................... PWE ....... 882.5801 

Monitor, Phonocardiographic, Fetal ................................................................................................. II ....................... HFP ........ 884.2640 

Monitor, Cardiac, Fetal ..................................................................................................................... II ....................... KXN ....... 884.2600 

Digital Pathology Display .................................................................................................................. II ....................... PZZ ........ 864.3700 

Digital Pathology Image Viewing And Management Software ........................................................ II ....................... QKQ ....... 864.3700 

4092 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

TABLE 2—REVIEW DEVICES WITH ZERO ADVERSE EVENT REPORTS IN MAUDE FOR THE TIME PERIOD NOVEMBER 1, 

2010 TO NOVEMBER 30, 2020—Continued 

Device description Device class Product 

code 

Section in 

21 CFR 

System, Imaging, Holography, Acoustic .......................................................................................... II ....................... NCS ....... 892.1550 

Lung Computed Tomography System, Computer-Aided Detection ................................................. II ....................... OEB ....... 892.2050 

Chest X-Ray Computer Aided Detection ......................................................................................... II ....................... OMJ ....... 892.2050 

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer ................................ II ....................... POK ....... 892.2060 

Radiological Computer-Assisted Triage And Notification Software ................................................. II ....................... QAS ....... 892.2080 

Radiological Computer Assisted Detection/Diagnosis Software For Fracture ................................. II ....................... QBS ....... 892.2090 

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer.II ....................... QDQ ....... 892.2090 

Radiological Computer-Assisted Prioritization Software For Lesions .............................................. II ....................... QFM ....... 892.2080 

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device .................... II ....................... QHA ....... 892.1600 

Automated Radiological Image Processing Software ...................................................................... II ....................... QIH ........ 892.2050 

Image Acquisition And/Or Optimization Guided By Artificial Intelligence ........................................ II ....................... QJU ........ 892.2100 

Apparatus, Vestibular Analysis ......................................................................................................... Unclassified ...... LXV ........ N/A 

Another 43 devices had no reports in 

MAUDE following declaration of the 

PHE, and the waiver of the 510(k) 

premarket notification requirement, 

with anywhere from 1 to 86 reports in 

MAUDE prior to the PHE for those same 

devices. For the ten-year period 

spanning November 1, 2010 to 

November 30, 2020, there were a total 

of 637 reports in MAUDE associated 

with theses 43 devices listed in Table 

3.1. This equates to about 1.5 MAUDE 

reports per year per device. Table 3.1 

below shows each device with the 

corresponding number of adverse events 

before and after the PHE. 

TABLE 3.1—REVIEW DEVICES WITH ZERO ADVERSE EVENTS POST-PHE AND 86 OR FEWER ADVERSE EVENTS PRE-PHE 

IN MAUDE 

Device description Device 

class 

Product 

code 

Section in 

21 CFR 

MAUDE 

events 

November 1, 

2010 to PHE 

MAUDE 

events 

Post-PHE 

to November 

30, 2020 

Patient Examination Glove, Specialty ..................................................... I .............. LZC ........ 880.6250 46 0 

Radiation Attenuating Medical Glove ...................................................... I .............. OPH ....... 880.6250 1 0 

Powder-Free Non-Natural Rubber Latex Surgeon’s Gloves ................... I .............. OPA ....... 878.4460 1 0 

Powder-Free Guayle Rubber Examination Glove ................................... I .............. OIG ........ 880.6250 2 0 

Latex Patient Examination Glove ............................................................ I .............. LYY ........ 880.6250 48 0 

Meter, Peak Flow, Spirometry ................................................................. II ............. BZH ........ 868.1860 27 0 

Monitor, Apnea, Facility Use ................................................................... II ............. FLS ........ 868.2377 86 0 

Monitor, Apnea, Home Use ..................................................................... II ............. NPF ........ 868.2377 41 0 

Oximeter, Reprocessed ........................................................................... II ............. NLF ........ 870.2700 65 0 

Stethoscope, Electronic ........................................................................... II ............. DQD ....... 870.1875 2 0 

Defoamer, Cardiopulmonary Bypass ...................................................... II ............. DTP ........ 870.4230 4 0 

Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass ......... II ............. JOD ........ 870.4270 2 0 

Detector, Bubble, Cardiopulmonary Bypass ........................................... II ............. KRL ........ 870.4205 44 0 

Cpb Check Valve, Retrograde Flow, In-Line .......................................... II ............. MJJ ........ 870.4400 12 0 

Sterilizer, Ethylene-Oxide Gas ................................................................ II ............. FLF ........ 880.6860 29 0 

Cabinet, Ethylene-Oxide Gas Aerator ..................................................... II ............. FLI .......... 880.6100 2 0 

Purifier, Air, Ultraviolet, Medical .............................................................. II ............. FRA ........ 880.6500 1 0 

Cleaner, Air, Medical Recirculating ......................................................... II ............. FRF ........ 880.5045 7 0 

Controller, Infusion, Intravascular, Electronic .......................................... II ............. LDR ........ 880.5725 27 0 

Cleaners, Medical Devices ...................................................................... II ............. MDZ ....... 880.6992 5 0 

Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position.II ............. OMF ....... 880.5970 9 0 

N95 Respirator With Antimicrobial/Antiviral Agent For Use By The 

General Public In Public Health Medical Emergencies.

II ............. ORW ...... 880.6260 1 0 

Two Or More Sterilant Sterilizer .............................................................. II ............. PJJ ......... 880.6860 6 0 

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist.II ............. OUJ ........ 892.1570 3 0 

Gown, Patient .......................................................................................... II ............. FYB ........ 878.4040 1 0 

Surgical Mask With Antimicrobial/Antiviral Agent ................................... II ............. OUK ....... 878.4040 1 0 

Cerebral Oximeter ................................................................................... II ............. QEM ....... 870.2700 2 0 

Device, Sleep Assessment ...................................................................... II ............. LEL ........ 882.5050 4 0 

Standard Polysomnograph With Electroencephalograph ....................... II ............. OLV ....... 882.1400 9 0 

Source Localization Software For Electroencephalograph Or 

Magnetoencephalograph.

II ............. OLX ........ 882.1400 2 0 

Automatic Event Detection Software For Polysomnograph With 

Electroencephalograph.

II ............. OLZ ........ 882.1400 1 0 

Amplitude-Integrated Electroencephalograph ......................................... II ............. OMA ....... 882.1400 1 0 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4093 

29For example, there was one MAUDE incident 

where a user reported suffering a third-degree burn 

after ‘‘pouring boiling nitric acid into a beaker and 

without warning a chemical reaction occurred 

causing acid to spill onto the wrist.’’ Nothing in the 

report indicates the gloves themselves caused the 

burn or otherwise exacerbated the burn. 

TABLE 3.1—REVIEW DEVICES WITH ZERO ADVERSE EVENTS POST-PHE AND 86 OR FEWER ADVERSE EVENTS PRE-PHE 

IN MAUDE—Continued 

Device description Device 

class 

Product 

code 

Section in 

21 CFR 

MAUDE 

events 

November 1, 

2010 to PHE 

MAUDE 

events 

Post-PHE 

to November 

30, 2020 

Automatic Event Detection Software For Full-Montage 

Electroencephalograph.

II ............. OMB ...... 882.1400 4 0 

Burst Suppression Detection Software For Electroencephalograph ....... II ............. ORT ....... 882.1400 1 0 

Monitor, Heart Rate, Fetal, Ultrasonic ..................................................... II ............. HEL ........ 884.2660 12 0 

Transducer, Ultrasonic, Obstetric ............................................................ II ............. HGL ....... 884.2960 6 0 

Uterine Electromyographic Monitor ......................................................... II ............. OSP ....... 884.2720 3 0

Tonometer, Ac-Powered .......................................................................... II ............. HKX ....... 886.1930 1 0 

Tonometer, Manual ................................................................................. II ............. HKY ....... 886.1930 8 0 

Automated Digital Image Manual Interpretation Microscope .................. II ............. OEO ....... 864.1860 1 0 

System, X-Ray, Tomographic ................................................................. II ............. IZF ......... 892.1740 35 0 

Analyzer, Medical Image ......................................................................... II ............. MYN ....... 892.2070 1 0 

C-Arm Fluoroscopic X-Ray System ........................................................ II ............. RCC ....... 892.1650 73 0 

The Department further analyzed the 

details of the MAUDE reports listed in 

Table 3.1. For the 5 class I glove devices 

listed, there were 98 reports. As shown 

in Table 3.2 below, after review of the 

detailed narratives for those 98 reports, 

they can be broken down into eight 

categories. 

TABLE 3.2—MAUDE REPORT BREAKDOWN FOR 5 CLASS I DEVICES IN TABLE 3.1 

Device description (Product 

Code) 

MAUDE report category 

Rip/tear/ 

hole 

Discolor/ 

debris 

Allergy/skin 

issue 

Not device 

related 

Improper 

use Mislabeled Odor Total 

Patient Examination Glove, Specialty (LZC) ............................... 22 19 4 1 0 0 0 46 

Radiation Attenuating Medical 

Glove (OPH) ............................. 0 0 0 0 1 0 0 1 

Powder-Free Non-Natural Rubber 

Latex Surgeon’s Gloves (OPA) 0 0 1 0 0 0 0 1 

Powder-Free Guayle Rubber Examination Glove (OIG) ............. 0 0 2 0 0 0 0 2 

Latex Patient Examination Glove 

(LYY) ........................................ 6 7 29 4 0 1 1 48 

Total ...................................... 28 26 36 5 1 1 1 98 

More than half of the reports (55%) 

related to material flaws such as tears, 

discoloration, or foreign debris in the 

gloves. For the 36 allergic reaction 

reports, there was only one report 

connected with a hospital visit for 

which the patient was ultimately 

monitored and discharged. There are 5 

MAUDE events from which the report 

narrative does not provide a basis to 

infer that the device itself caused the 

harm.29 None of the 98 reports involved 

a death. 

The 38 class II devices listed in Table 

3.1 were connected to another 539 

MAUDE reports. Of those reports, 322 

(59.7%) involved device malfunctions, 

71 (13.2%) involved injuries, 22 (4.1%) 

involved deaths, and 124 (23%) have 

the event type listed as ‘‘other’’ or 

‘‘NA.’’ Table 3.3 below provides the 

breakdown of the 539 MAUDE reports 

by device type. 

TABLE 3.3—MAUDE REPORT BREAKDOWN FOR 38 CLASS II DEVICES IN TABLE 3.1 

Device description Product 

code 

MAUDE report category 

Malfunction Injury Death Other NA Total 

Meter, Peak Flow, Spirometry ....................................................... BZH ........ 26 1 0 0 0 27 

Monitor, Apnea, Facility Use ......................................................... FLS ........ 52 9 16 9 0 86 

Monitor, Apnea, Home Use ........................................................... NPF ........ 34 5 2 0 0 41 

Oximeter, Reprocessed ................................................................. NLF ........ 49 14 0 0 2 65 

Stethoscope, Electronic ................................................................. DQD ....... 1 0 0 1 0 2 

Defoamer, Cardiopulmonary Bypass ............................................. DTP ........ 3 1 0 0 0 4 

Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass JOD ........ 1 0 0 1 0 2 

4094 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

TABLE 3.3—MAUDE REPORT BREAKDOWN FOR 38 CLASS II DEVICES IN TABLE 3.1—Continued 

Device description Product 

code 

MAUDE report category 

Malfunction Injury Death Other NA Total 

Detector, Bubble, Cardiopulmonary Bypass ................................. KRL ........ 33 0 0 1 10 44 

Cpb Check Valve, Retrograde Flow, In-Line ................................. MJJ ........ 11 1 0 0 0 12 

Sterilizer, Ethylene-Oxide Gas ...................................................... FLF ........ 7 9 0 1 12 29 

Cabinet, Ethylene-Oxide Gas Aerator ........................................... FLI .......... 0 2 0 0 0 2 

Purifier, Air, Ultraviolet, Medical .................................................... FRA ........ 1 0 0 0 0 1 

Cleaner, Air, Medical Recirculating ............................................... FRF ........ 6 0 0 0 1 7 

Controller, Infusion, Intravascular, Electronic ................................ LDR ........ 27 0 0 0 0 27 

Cleaners, Medical Devices ............................................................ MDZ ....... 4 0 0 1 0 5 

Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position.OMF ....... 3 2 0 4 0 9 

N95 Respirator With Antimicrobial/Antiviral Agent For Use By 

The General Public In Public Health Medical Emergencies.

ORW ...... 1 0 0 0 0 1 

Two Or More Sterilant Sterilizer .................................................... PJJ ......... 0 6 0 0 0 6 

High Level Disinfection Reprocessing Instrument For Ultrasonic 

Transducers, Mist.

OUJ ........ 1 1 0 1 0 3 

Gown, Patient ................................................................................ FYB ........ 0 0 1 0 0 1 

Surgical Mask With Antimicrobial/Antiviral Agent .......................... OUK ....... 0 1 0 0 0 1 

Cerebral Oximeter ......................................................................... QEM ....... 1 1 0 0 0 2 

Device, Sleep Assessment ............................................................ LEL ........ 4 0 0 0 0 4 

Standard Polysomnograph With Electroencephalograph .............. OLV ........ 7 2 0 0 0 9 

Source Localization Software For Electroencephalograph Or 

Magnetoencephalograph.

OLX ........ 1 1 0 0 0 2 

Automatic Event Detection Software For Polysomnograph With 

Electroencephalograph.

OLZ ........ 0 1 0 0 0 1 

Amplitude-Integrated Electroencephalograph ............................... OMA ....... 1 0 0 0 0 1 

Automatic Event Detection Software For Full-Montage 

Electroencephalograph.

OMB ....... 1 0 0 1 2 4 

Burst Suppression Detection Software For 

Electroencephalograph.

ORT ....... 1 0 0 0 0 1 

Monitor, Heart Rate, Fetal, Ultrasonic ........................................... HEL ........ 9 2 1 0 0 12 

Transducer, Ultrasonic, Obstetric .................................................. HGL ....... 0 6 0 0 0 6 

Uterine Electromyographic Monitor ............................................... OSP ....... 1 1 1 0 0 3 

Tonometer, Ac-Powered ................................................................ HKX ....... 0 0 0 0 1 1 

Tonometer, Manual ........................................................................ HKY ....... 3 4 0 1 0 8 

Automated Digital Image Manual Interpretation Microscope ........ OEO ....... 1 0 0 0 0 1 

System, X-Ray, Tomographic ........................................................ IZF ......... 31 1 1 1 1 35 

Analyzer, Medical Image ............................................................... MYN ....... 1 0 0 0 0 1 

C-Arm Fluoroscopic X-Ray System ............................................... RCC ....... 0 0 0 1 72 73 

Total ........................................................................................ ................ 322 71 22 23 101 539 

An additional 32 devices had from 1 

to 32 reports in MAUDE after the PHE 

began and anywhere from 1 to 78 

reports in MAUDE from November 1, 

2010 to the start of the PHE. These 

devices are shown in Table 4.1 below. 

TABLE 4.1—REVIEW DEVICES WITH MAUDE REPORTS BEFORE AND AFTER PHE 

Device description Device 

class 

Product 

code 

Section in 

21 CFR 

MAUDE 

events 

November 1, 

2010 to PHE 

MAUDE 

events 

Post-PHE to 

November 30, 

2020 

Vinyl Patient Examination Glove ............................................................. I .............. LYZ ........ 880.6250 40 1 

Mechanical Ventilator .............................................................................. II ............. ONZ ....... 868.5895 2 1 

Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection.II ............. NCP ....... 870.4210 6 1 

Dual Lumen Ecmo Cannula .................................................................... II ............. PZS ........ 870.4100 2 4 

Respirator, N95, For Use By The General Public In Public Health 

Medical Emergencies.

II ............. NZJ ........ 880.6260 1 1 

Sterilizer Automated Loading System ..................................................... II ............. PEC ....... 880.6880 8 1 

Infusion Safety Management Software ................................................... II ............. PHC ....... 880.5725 6 1 

Gown, Isolation, Surgical ......................................................................... II ............. FYC ........ 878.4040 12 1 

Non-Normalizing Quantitative Electroencephalograph Software ............ II ............. OLT ........ 882.1400 12 1 

Monitor, Ultrasonic, Fetal ........................................................................ II ............. KNG ....... 884.2660 16 2 

Whole Slide Imaging System .................................................................. II ............. PSY ........ 864.3700 2 1 

Oxygenator, Long Term Support Greater Than 6 Hours ........................ II ............. BZG ....... 868.1840 10 1 

Transmitters And Receivers, Electrocardiograph, Telephone ................ II ............. BZQ ....... 868.2375 38 8 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4095 

TABLE 4.1—REVIEW DEVICES WITH MAUDE REPORTS BEFORE AND AFTER PHE—Continued 

Device description Device 

class 

Product 

code 

Section in 

21 CFR 

MAUDE 

events 

November 1, 

2010 to PHE 

MAUDE 

events 

Post-PHE to 

November 30, 

2020 

Extracorporeal System For Long-Term Respiratory/Cardiopulmonary 

Failure.

II ............. NFB ........ 868.5905 24 1 

Catheter, Percutaneous, Intraspinal, Short Term ................................... II ............. NHJ ........ 868.5905 18 2 

Implanted Subcutaneous Securement Catheter ..................................... II ............. NHK ....... 868.5905 78 1 

Subcutaneous Implanted Apheresis Port ................................................ II ............. QAV ....... 868.5454 0 1 

Non-Coring (Huber) Needle .................................................................... II ............. BYS ........ 870.4100 0 1 

Administrations Sets With Neuraxial Connectors ................................... II ............. DXH ....... 870.2920 18 5 

Port & Catheter, Implanted, Subcutaneous, Intraventricular .................. II ............. QJZ ........ 870.4100 0 12 

Hood, Surgical ......................................................................................... II ............. MAJ ........ 868.5120 17 1 

N95 Respirator With Antimicrobial/Antiviral Agent .................................. II ............. OKC ....... 880.5970 16 1 

Reduced- Montage Standard Electroencephalograph ............................ II ............. PTD ........ 880.5965 40 32 

Monitor, Uterine Contraction, External (For Use In Clinic) ..................... II ............. PTI ......... 880.5570 36 10 

Coil, Magnetic Resonance, Specialty ...................................................... II ............. PWH ...... 880.5440 0 5 

Solid State Fluoroscopic X-Ray Imager .................................................. II ............. LKG ....... 882.5550 20 1 

Oxygenator, Long Term Support Greater Than 6 Hours ........................ II ............. FXY ........ 878.4040 20 1 

Transmitters And Receivers, Electrocardiograph, Telephone ................ II ............. ONT ....... 878.4040 0 1 

Extracorporeal System For Long-Term Respiratory/Cardiopulmonary 

Failure.

II ............. OMC ...... 882.1400 0 1 

Catheter, Percutaneous, Intraspinal, Short Term ................................... II ............. HFM ....... 884.2720 13 1 

Implanted Subcutaneous Securement Catheter ..................................... II ............. MOS ....... 892.1000 72 1 

Subcutaneous Implanted Apheresis Port ................................................ II ............. QHY ....... 892.1650 0 1 

Table 4.2 presents the devices in 

Table 4.1 broken down by type of 

MAUDE. Of the 630 MAUDE reports 

analyzed, the majority (383 or 60.7%) 

involved product malfunctions with a 

limited number connected to death (24 

or 3.8%). 

TABLE 4.2—REVIEW DEVICES IN TABLE 4.1 BY MAUDE REPORT

Device descriptions Device 

class 

Product 

code 

MAUDE Reports 

Malfunction Death Injury Other NA Total 

Vinyl Patient Examination Glove ............................... I .............. LYZ ........ 20 0 19 1 1 41 

Mechanical Ventilator ................................................ II ............. ONZ ....... 1 1 1 0 0 3 

Cannula, Arterial, Cardiopulmonary Bypass (Cpb), 

Embolism Protection.

II ............. NCP ....... 2 0 5 0 0 7 

Dual Lumen Ecmo Cannula ...................................... II ............. PZS ........ 1 1 4 0 0 6 

Respirator, N95, For Use By The General Public In 

Public Health Medical Emergencies.

II ............. NZJ ........ 1 0 1 0 0 2 

Sterilizer Automated Loading System ....................... II ............. PEC ....... 7 0 2 0 0 9 

Infusion Safety Management Software ..................... II ............. PHC ....... 7 0 0 0 0 7 

Gown, Isolation, Surgical ........................................... II ............. FYC ........ 12 0 1 0 0 13 

Non-Normalizing Quantitative 

Electroencephalograph Software.

II ............. OLT ........ 11 2 0 0 0 13 

Monitor, Ultrasonic, Fetal .......................................... II ............. KNG ....... 2 1 15 0 0 18 

Whole Slide Imaging System .................................... II ............. PSY ........ 2 0 1 0 0 3 

Oxygenator, Long Term Support Greater Than 6 

Hours.

II ............. BZG ....... 7 0 2 1 1 11 

Transmitters And Receivers, Electrocardiograph, 

Telephone.

II ............. BZQ ....... 38 5 3 0 0 46 

Extracorporeal System For Long-Term Respiratory/ 

Cardiopulmonary Failure.

II ............. NFB ........ 11 4 9 1 0 25 

Catheter, Percutaneous, Intraspinal, Short Term ...... II ............. NHJ ........ 10 1 9 0 0 20 

Implanted Subcutaneous Securement Catheter ....... II ............. NHK ....... 68 4 6 0 1 79 

Subcutaneous Implanted Apheresis Port .................. II ............. QAV ....... 1 0 0 0 0 1 

Non-Coring (Huber) Needle ...................................... II ............. BYS ........ 1 0 0 0 0 1 

Administrations Sets With Neuraxial Connectors ...... II ............. DXH ....... 9 1 9 0 4 23 

Port & Catheter, Implanted, Subcutaneous, 

Intraventricular.

II ............. QJZ ........ 9 1 2 0 0 12 

Hood, Surgical ........................................................... II ............. MAJ ........ 12 0 6 0 0 18 

N95 Respirator With Antimicrobial/Antiviral Agent .... II ............. OKC ....... 12 0 3 1 1 17 

Reduced- Montage Standard 

Electroencephalograph.

II ............. PTD ........ 52 1 19 0 0 72 

Monitor, Uterine Contraction, External (For Use In 

Clinic).

II ............. PTI ......... 22 0 24 0 0 46 

Coil, Magnetic Resonance, Specialty ........................ II ............. PWH ...... 5 0 0 0 0 5 

4096 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

TABLE 4.2—REVIEW DEVICES IN TABLE 4.1 BY MAUDE REPORT—Continued 

Device descriptions Device 

class 

Product 

code 

MAUDE Reports 

Malfunction Death Injury Other NA Total 

Solid State Fluoroscopic X-Ray Imager .................... II ............. LKG ....... 16 1 4 0 0 21 

Oxygenator, Long Term Support Greater Than 6 

Hours.

II ............. FXY ........ 19 0 2 0 0 21 

Transmitters And Receivers, Electrocardiograph, 

Telephone.

II ............. ONT ....... 0 0 1 0 0 1 

Extracorporeal System For Long-Term Respiratory/ 

Cardiopulmonary Failure.

II ............. OMC ...... 1 0 0 0 0 1 

Catheter, Percutaneous, Intraspinal, Short Term ...... II ............. HFM ....... 10 1 3 0 0 14 

Implanted Subcutaneous Securement Catheter ....... II ............. MOS ....... 13 0 52 7 1 73 

Subcutaneous Implanted Apheresis Port .................. II ............. QHY ....... 1 0 0 0 0 1 

.................................................................................... Total ....... 383 24 203 11 9 630 

III. Exemption from 510(k) Premarket 

Notification Requirement 

A. Class I Devices 

Section 510(l)(2)(A)–(B) of the FD&C 

Act, 21 U.S.C. 360(l)(2)(A)–(B), provides 

that ‘‘the Secretary shall identify 

through publication in the Federal 

Register, any type of class I device that 

the Secretary determines no longer 

requires a report under subsection (k) to 

provide reasonable assurance of safety 

and effectiveness’’ and that ‘‘[u]pon 

such publication—each type of class I 

device so identified shall be exempt 

from the requirement for a report under 

subsection (k); and the classification 

regulation applicable to each such type 

of device shall be deemed amended to 

incorporate such exemption.’’ 

In view of the complete lack of or de 

minimis number of adverse events in 

MAUDE following FDA’s waiver of the 

premarket notification requirement for 

the class I devices listed in Tables 2, 3.1, 

and 4.1, the Department has concluded 

that the premarket notification 

requirement is no longer required to 

provide reasonable assurance of the 

safety and efficacy of those devices. As 

such, as of this Notice, the 7 class I 

devices listed in Table 5 below shall be 

exempt from the 510(k) premarket 

notification requirement. 

TABLE 5—CLASS I DEVICES IMMEDIATELY EXEMPT FROM 510(k) NOTIFICATION REQUIREMENT

Device 

description 

Device 

class 

Product 

code 

Section in 

21 CFR 

Powder-Free Polychloroprene Patient Examination Glove ............................................................................. I .............. OPC ....... 880.6250 

Patient Examination Glove, Specialty ............................................................................................................. I .............. LZC ........ 880.6250 

Radiation Attenuating Medical Glove .............................................................................................................. I .............. OPH ....... 880.6250 

Powder-Free Non-Natural Rubber Latex Surgeon’’s Gloves .......................................................................... I .............. OPA ....... 878.4460 

Powder-Free Guayle Rubber Examination Glove ........................................................................................... I .............. OIG ........ 880.6250 

Latex Patient Examination Glove .................................................................................................................... I .............. LYY ........ 880.6250 

Vinyl Patient Examination Glove ..................................................................................................................... I .............. LYZ ........ 880.6250 

B. Class II Devices 

Section 510(m)(2) of the FD&C Act, 21 

U.S.C. 360(m)(2), provides that, after a 

60-calendar-day-notice comment period, 

‘‘the Secretary may exempt a class II 

device from the requirement to submit 

a report under subsection (k) . . . if the 

Secretary determines that such report is 

not necessary to assure the safety and 

effectiveness of the device.’’ Within 120 

days of publication, ‘‘the Secretary shall 

publish an order in the Federal Register 

that sets forth the final determination of 

the Secretary regarding the exemption of 

the device that was the subject of the 

notice.’’ Given the lack of any adverse 

event reports in MAUDE for class II and 

the unclassified medical devices listed 

in Table 2, and the lack of non-deathrelated adverse event reports for class II 

devices in Tables 3.3 and 4.2, the 

Department has determined that 510(k) 

premarket notification for the 84 class II 

devices and the unclassified device 

listed in Table 6 below is no longer 

necessary to assure the safety and 

effectiveness of those devices. 

TABLE 6—CLASS II DEVICES AND UNCLASSIFIED DEVICES PROPOSED EXEMPT FROM 510(k) REQUIREMENT

Device 

description 

Device 

class 

Product 

code 

Section in 

21 CFR 

Ventilator, Continuous, Minimal Ventilatory Support, Home Use ................................................................... II ............. NQY ....... 868.5895 

Airway Monitoring System ............................................................................................................................... II ............. OQU ....... 868.5730 

Impedance Measuring Device Utilizing Oscillation Techniques ..................................................................... II ............. PNV ....... 868.1840 

Gauge, Pressure, Coronary, Cardiopulmonary Bypass .................................................................................. II ............. DXS ....... 870.4310 

Valve, Pressure Relief, Cardiopulmonary Bypass .......................................................................................... II ............. MNJ ....... 870.4400 

Oximeter, Tissue Saturation, Reprocessed .................................................................................................... II ............. NMD ....... 870.2700 

Multivariate Vital Signs Index .......................................................................................................................... II ............. PLB ........ 870.2300 

Electrocardiograph Software For Over-The-Counter Use .............................................................................. II ............. QDA ....... 870.2345 

Sterilizer, Dry Heat .......................................................................................................................................... II ............. KMH ....... 880.6870 

Check Valve, Retrograde Flow (In-Line) ......................................................................................................... II ............. MJF ........ 880.5440 

Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4097 

TABLE 6—CLASS II DEVICES AND UNCLASSIFIED DEVICES PROPOSED EXEMPT FROM 510(k) REQUIREMENT—Continued 

Device 

description 

Device 

class 

Product 

code 

Section in 

21 CFR 

Intravascular Administration Set, Automated Air Removal System ................................................................ II ............. OKL ....... 880.5445 

Neuraxial Administration Set—Intrathecal Delivery ........................................................................................ II ............. PYR ....... 880.5440 

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid .................................. II ............. PSW ....... 892.1570 

Pediatric/Child Facemask ................................................................................................................................ II ............. OXZ ....... 878.4040 

Normalizing Quantitative Electroencephalograph Software ............................................................................ II ............. OLU ....... 882.1400 

Computerized Cognitive Assessment Aid ....................................................................................................... II ............. PKQ ....... 882.1470 

Physiological Signal Based Seizure Monitoring System ................................................................................ II ............. POS ....... 882.1580 

Computerized Behavioral Therapy Device For Psychiatric Disorders ............................................................ II ............. PWE ....... 882.5801 

Monitor, Phonocardiographic, Fetal ................................................................................................................ II ............. HFP ........ 884.2640 

Monitor, Cardiac, Fetal .................................................................................................................................... II ............. KXN ....... 884.2600 

Digital Pathology Display ................................................................................................................................ II ............. PZZ ........ 864.3700 

Digital Pathology Image Viewing And Management Software ....................................................................... II ............. QKQ ....... 864.3700 

System, Imaging, Holography, Acoustic ......................................................................................................... II ............. NCS ....... 892.1550 

Lung Computed Tomography System, Computer-Aided Detection ............................................................... II ............. OEB ....... 892.2050 

Chest X-Ray Computer Aided Detection ........................................................................................................ II ............. OMJ ....... 892.2050 

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer .............................................. II ............. POK ....... 892.2060 

Radiological Computer-Assisted Triage And Notification Software ................................................................ II ............. QAS ....... 892.2080 

Radiological Computer Assisted Detection/Diagnosis Software For Fracture ............................................... II ............. QBS ....... 892.2090 

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer ........... II ............. QDQ ....... 892.2090 

Radiological Computer-Assisted Prioritization Software For Lesions ............................................................. II ............. QFM ....... 892.2080 

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device .................................. II ............. QHA ....... 892.1600 

Automated Radiological Image Processing Software ..................................................................................... II ............. QIH ........ 892.2050 

Image Acquisition And/Or Optimization Guided By Artificial Intelligence ....................................................... II ............. QJU ........ 892.2100 

Apparatus, Vestibular Analysis ....................................................................................................................... Unclassified.LXV ........ N/A 

Meter, Peak Flow, Spirometry ......................................................................................................................... II ............. BZH ........ 868.1860 

Oximeter, Reprocessed ................................................................................................................................... II ............. NLF ........ 870.2700 

Stethoscope, Electronic ................................................................................................................................... II ............. DQD ....... 870.1875 

Defoamer, Cardiopulmonary Bypass .............................................................................................................. II ............. DTP ........ 870.4230 

Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass ................................................................. II ............. JOD ........ 870.4270 

Detector, Bubble, Cardiopulmonary Bypass ................................................................................................... II ............. KRL ........ 870.4205 

Cpb Check Valve, Retrograde Flow, In-Line .................................................................................................. II ............. MJJ ........ 870.4400 

Sterilizer, Ethylene-Oxide Gas ........................................................................................................................ II ............. FLF ........ 880.6860 

Cabinet, Ethylene-Oxide Gas Aerator ............................................................................................................. II ............. FLI .......... 880.6100 

Purifier, Air, Ultraviolet, Medical ...................................................................................................................... II ............. FRA ........ 880.6500 

Cleaner, Air, Medical Recirculating ................................................................................................................. II ............. FRF ........ 880.5045 

Controller, Infusion, Intravascular, Electronic ................................................................................................. II ............. LDR ........ 880.5725 

Cleaners, Medical Devices .............................................................................................................................. II ............. MDZ ....... 880.6992 

Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position ................... II ............. OMF ....... 880.5970 

N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies.II ............. ORW ...... 880.6260 

Two Or More Sterilant Sterilizer ...................................................................................................................... II ............. PJJ ......... 880.6860 

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist ..................................... II ............. OUJ ........ 892.1570 

Surgical Mask With Antimicrobial/Antiviral Agent ........................................................................................... II ............. OUK ....... 878.4040 

Cerebral Oximeter ........................................................................................................................................... II ............. QEM ....... 870.2700 

Device, Sleep Assessment ............................................................................................................................. II ............. LEL ........ 882.5050 

Standard Polysomnograph With Electroencephalograph ............................................................................... II ............. OLV ....... 882.1400 

Source Localization Software For Electroencephalograph Or Magnetoencephalograph ............................... II ............. OLX ....... 882.1400 

Automatic Event Detection Software For Polysomnograph With Electroencephalograph ............................. II ............. OLZ ........ 882.1400 

Amplitude-Integrated Electroencephalograph ................................................................................................. II ............. OMA ....... 882.1400 

Automatic Event Detection Software For Full-Montage Electroencephalograph ........................................... II ............. OMB ....... 882.1400 

Burst Suppression Detection Software For Electroencephalograph .............................................................. II ............. ORT ....... 882.1400 

Transducer, Ultrasonic, Obstetric .................................................................................................................... II ............. HGL ....... 884.2960 

Tonometer, Ac-Powered ................................................................................................................................. II ............. HKX ....... 886.1930 

Tonometer, Manual ......................................................................................................................................... II ............. HKY ....... 886.1930 

Automated Digital Image Manual Interpretation Microscope .......................................................................... II ............. OEO ....... 864.1860 

Analyzer, Medical Image ................................................................................................................................. II ............. MYN ....... 892.2070 

C-Arm Fluoroscopic X-Ray System ................................................................................................................ II ............. RCC ....... 892.1650 

Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection ..................................................... II ............. NCP ....... 870.4210 

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies ............................ II ............. NZJ ........ 880.6260 

Sterilizer Automated Loading System ............................................................................................................. II ............. PEC ....... 880.6880 

Infusion Safety Management Software ........................................................................................................... II ............. PHC ....... 880.5725 

Gown, Isolation, Surgical ................................................................................................................................ II ............. FYC ........ 878.4040 

Whole Slide Imaging System .......................................................................................................................... II ............. PSY ........ 864.3700 

Oxygenator, Long Term Support Greater Than 6 Hours ................................................................................ II ............. BZG ....... 868.1840 

Subcutaneous Implanted Apheresis Port ........................................................................................................ II ............. QAV ....... 868.5454 

Non-Coring (Huber) Needle ............................................................................................................................ II ............. BYS ........ 870.4100 

Hood, Surgical ................................................................................................................................................. II ............. MAJ ........ 868.5120 

N95 Respirator With Antimicrobial/Antiviral Agent .......................................................................................... II ............. OKC ....... 880.5970 

Monitor, Uterine Contraction, External (For Use In Clinic) ............................................................................. II ............. PTI ......... 880.5570 

Coil, Magnetic Resonance, Specialty ............................................................................................................. II ............. PWH ...... 880.5440 

4098 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

TABLE 6—CLASS II DEVICES AND UNCLASSIFIED DEVICES PROPOSED EXEMPT FROM 510(k) REQUIREMENT—Continued 

Device 

description 

Device 

class 

Product 

code 

Section in 

21 CFR 

Oxygenator, Long Term Support Greater Than 6 Hours ................................................................................ II ............. FXY ........ 878.4040 

Transmitters And Receivers, Electrocardiograph, Telephone ........................................................................ II ............. ONT ....... 878.4040 

Extracorporeal System For Long-Term Respiratory/Cardiopulmonary Failure .............................................. II ............. OMC ...... 882.1400 

Implanted Subcutaneous Securement Catheter ............................................................................................. II ............. MOS ....... 892.1000 

Subcutaneous Implanted Apheresis Port ........................................................................................................ II ............. QHY ....... 892.1650 

C. Impact of Exemptions on Patient 

Access to Medical Devices 

With this Notice, the Department is 

immediately exempting 7 devices from 

the premarket notification requirement, 

and proposes to exempt an additional 

84 devices from the requirement after 

public comment is closed. As noted 

above in Part I.A, estimates on the cost 

of preparing a 510(k) submission range 

from $100,000 to $4 million. The 

exemptions provided for and proposed 

under this Notice for these 91 device 

classes could eliminate anywhere from 

$9.1 to $364 million in startup costs if 

there were one new entrant into each 

device market. Savings could further 

accrue based on each new market 

entrant. Instead of being costs passed 

along to patients and taxpayers, these 

savings could be invested in other areas 

such as research and development and 

manufacturing. 

At the same time, should these 

waivers go into effect as proposed, 

patients stand to gain more immediate 

access to new products that would 

otherwise be required to obtain a 510(k) 

clearance prior to marketing. 

The exemptions provided for in this 

Notice also conserve FDA’s scarce 

review resources. The COVID–19 PHE 

stretched FDA’s review capacity. Under 

this Notice, FDA’s review resources can 

be redeployed to review other 

innovative technology, to include 

devices designed to mitigate the impact 

of COVID–19. 

IV. Request for Information, Data, and 

Further Study 

HHS’ review in this Notice warrants 

expansion and further study. FDA’s 

medical device Product Code database 

contains 6,651 unique codes (to include 

those discussed in this Notice). Of those 

unique codes, 157 are for class I devices 

that require 510(k) clearance, and 2,662 

are for class II devices that require 

510(k) clearance. Applying the $100,000 

to $4 million in estimated costs for 

510(k) preparation and submission to 

these 2,819 devices yields 

approximately $281.9 million to 

$11.276 billion in startup costs, 

assuming one new market entrant in 

each of the 2,819 device classes. 

Further, again assuming a 90-day review 

period and one new device entrant in 

each of the 2,819 device classes that 

require 510(k) notification, FDA’s 

current approach creates 253,710 review 

days or 695.1 review years between 

Americans and new devices. The 

question of whether the 510(k) notice is 

justified in view of safety and efficacy 

concerns merits comprehensive analysis 

for the benefit of Americans. The 

Department seeks public comment, 

research, and analysis on whether other 

devices should be exempt from the 

premarket notification requirement. 

At a more detailed level, the 

Department observed internal 

inconsistencies in FDA’s regulation of 

some device classes that merit 

discussion. Manual stethoscopes are 

exempt from the premarket notification 

requirement. 21 CFR 870.1875(a)(2). 

Electronic stethoscopes are also exempt, 

but only if the device ‘‘is a lung sound 

monitor.’’ 21 CFR 870.1875(b)(2). 

Similarly, FDA exempts ‘‘clinical 

mercury thermometer . . . device[s] 

used to measure oral, rectal, or axillary 

(armpit) body temperature using the 

thermal expansion of mercury’’ from the 

510(k) premarket notification 

requirement. 21 CFR 880.2920. By 

contrast, clinical electronic 

thermometers which never enter into 

any body orifice require 510(k) 

premarket notification. 21 CFR 

880.2910. These apparent 

inconsistencies merit scientific scrutiny. 

To that end, the Department seeks 

public comment as to whether other 

inconsistencies in the medical device 

regulatory framework exist. 

Dated: January 8, 2021. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–00787 Filed 1–14–21; 8:45 am] 

BILLING CODE 4150–26–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1657] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Survey of Drug 

Product Manufacturing, Processing, 

and Packing Facilities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by February 

16, 2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comment’’ or 

by using the search function. The title 

of this information collection is ‘‘Survey 

of Drug Product Manufacturing, 

Processing, and Packing Facilities.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance.