MD _ Emerging Labeling Regulations

FDA is committed to providing timely guidance to support response efforts to this pandemic situation of COVID-19. In this regard FDA has
implemented few guidance documents immediately without prior public comment, because this is not feasible or appropriate at this pandemic
time, but it remains subject to comment in accordance with the Agency's good guidance practices. As recommended by FDA the devices
submission would be required as per Quality System Regulation requirements (21 CFR Part 820 {21 CFR Subpart K - § 820.120 Device labeling & §
820.130 Device packaging Control}), Reports of Corrections and Removals requirements (21 CFR Part 806 {reporting information}), and Label to
bear a unique device identifier (21 CFR Part 830 and 21 CFR 801.20) regulations as necessary.
The recommended guidance documents contains proposed changes in both the device technical function and labeling context (including methods,
standards, etc). Below are some of the medical devices types as per new recommendations.
A. Remote Ophthalmic Assessment and Monitoring Devices
B. Sterilizers, Disinfectant Devices, and Air Purifiers
C. Infusion Pumps and Accessories
D. Face Masks and Respirators
E. EUAs for Face Masks and Respirators

A. Modifications for Remote Ophthalmic Assessment and Monitoring

FDA expanding the capability of remote ophthalmic assessment and monitoring devices and Tonometers may help facilitate patient care while reducing patient
and healthcare provider contact and risk of exposure to SARS-CoV-2. Recommended modification for device function/indications provided in Table 1 and labeling
modification are in Table 2.

TABLE 1: Modifications on the Indications and Functionality

Device Type Product Code Device Classification Modification to Devices on Indication, functionality and software/Hardware

1.Visual Acuity Charts, Visual Field Devices, and General-Use Ophthalmic Cameras

Camera, Ophthalmic, 1. Indications and functionality designed to permit the use of the device for
PJZ II (exempt)
General-use  monitoring and/or assessment of the ophthalmic parameters (not
indicated/designed)
Visual Acuity Chart HOX I (exempt)  Home use and/or by consumers rather than eye care providers
 Telemedicine consultation, allowing the eye care provider to assess specific
Amsler Grid HOQ I (exempt) ophthalmic parameters remotely.
2. Devices containing software and/or hardware intended to
Perimeter, HOO I (exempt)  Implement intended device functionality for use directly by consumers at home
(e.g., visual acuity assessment, visual field assessment, image capture).
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AC-powered  Facilitate remote access (e.g., addition of wireless or Bluetooth capability).

2. Tonometers

Tonometer, AC-powered HKX II 1. The device is intended to


determine when patients need immediate clinical intervention to assure patient
safety
 be solely or primarily relied upon by the eye care provider or patient to make a
clinical diagnosis or treatment decision;
Tonometer, Manual HKY II 2. The modifications add the functionality to
 acquire, process, or analyze a pattern or signal from a signal acquisition system
that was not present in the FDA-cleared device; or
Modifications are made to device components that have direct contact with the eye.

Table 2: Labeling Modifications for Remote Ophthalmic Assessment and Monitoring Devices and Tonometers:
FDA Recommended Labeling Modifications LABELING IMPACT (Yes/No)
IFU Artwork
1) A clear description of the available data on the device’s new indications, and/or functions including information
regarding: Yes
a. Device performance; Yes (indication
b. Method of determining any diagnostic or treatment recommendations; and statement)
c. Potential risks.
2) Adequate instructions for use for the intended user and indicated environment(s) of use. The labeling should highlight Yes
the differences in design compared to the unmodified version of the device, along with instructions for mitigating any Yes (usage of
known risks associated with these differences. symbol)
3) Information so that the eye care provider and/or patient can independently review the basis for any diagnostic or
Yes No
treatment recommendations
4) For devices previously cleared for use only in a hospital or other health care facility and for which the environment of
use has been expanded to include in-home use, adequate instructions for use in the home setting with appropriate lay Yes Yes
terminology
5) For FDA-cleared devices, clear distinction delineating FDA-cleared indications from those that are not FDA-cleared. In
Yes Yes
addition, FDA recommends the labeling include a general statement about changes that have not been cleared by FDA.
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For exempt devices listed in Table 1, FDA recommends that the labeling include a statement about indications outside
the limitations of exemption in 21 CFR 886.9 for that device type.
6) A prominent notice to both the patient and eye care provider that recommendations provided by the device are
Yes No
adjunctive (supporting) and should not be solely or primarily relied upon to prevent, diagnose, or treat ocular conditions

B. Modifications for Sterilizers, Disinfectant Devices, and Air Purifiers:

FDA has recommended standards (TABLE 3) and labeling modifications (Table 4) on sterilized or disinfected conditions to patients and healthcare providers for usage
of sterilizers, disinfectant devices, and air purifiers during this public health emergency.

TABLE 3: Modifications/applied standards for Sterilizers, Disinfectant devices, and Air purifiers

FDA-Recommended standards for Sterilized or Disinfected Devices on Indication

Device Type Product Code Device Classification
or functionality

I. Sterilizers
Endodontic dry heat
KOK III
sterilizer  Steam Sterilizers
o ANSI/AAMI ST8:2013 Hospital Steam Sterilizers
Glass bead sterilizer ECC III
o ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers
Ethylene-oxide (EO) gas o ANSI/AAMI ST79:2019 Comprehensive Guide to Steam Sterilization and
FLI II
aerator cabinet Sterility Assurance in Health Care Facilities.
Chemical Sterilizer MLR II  Dry Heat Sterilizers
o AAMI ST50:2004 (R2018) Dry Heat (Heated Air) Sterilizers
Two or more sterilant o ANSI/AAMI ST40:2004m (R2018) Table-Top Dry Heat (Heated Air)
PJJ II
sterilizer Sterilization and Sterility Assurance in Health Care Facilities
EO gas sterilizer FLF II  Ethylene Oxide Sterilizers
o ANSI/AAMI ST24:1999 (R2018) Automatic, General Purpose Ethylene
Dry heat sterilizer KMH II Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in
II Health Care Facilities, 3ed.
Steam sterilizer FLE
o ANSI/AAMI ST41:2008 (R2018) Ethylene Oxide Sterilization in Health Care
PEC II Facilities: Safety and Effectiveness
Sterilizer automated
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loading system  Other Sterilizers

o ANSI/AAMI/ISO 14937 Sterilization of Health Care Products — General
Requirements for Characterization of a Sterilizing Agent and the
Development, Validation and Routine Control of a Sterilization Process for
Medical Devices
 Chemical Indicators
o ANSI/AAMI/ISO 11140 – 1 Sterilization of Health Care Products—Chemical
Indicators—Part 1: General Requirements
 Sterile Packaging
o ANSI/AAMI/ISO 11607-1 Packaging for Terminally Sterilized Medical
Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and
Packaging Systems
o ANSI/AAMI/ISO 11607-2 Packaging for Terminally Sterilized Medical
Devices
 Rigid Sterilization Containers
o ANSI/AAMI/ISO ST77:2013 Containment Devices for Reusable Medical
Device Sterilization
 Biological Indicators
o ANSI/AAMI/ISO 11138 Sterilization of Health Care Products—Biological
Indicators Series
o ANSI/AAMI/ISO 14161 Sterilization of Health Care Products — Biological
Indicators — Guidance for the Selection, Use and Interpretation of Results

II. Disinfectant Devices

1.Chemical/Physical Disinfectant Devices

Cleaning accessories for

FEB II
endoscope  AAMI ST58:2013 (R2018) Chemical Sterilization and High-Level Disinfection
in Health Care Facilities
Medical devices sterilant MED II
 Association of Official Analytical Chemists (AOAC) 6.3.05:2013 Official
II Method 966.04 Sporicidal Activity of Disinfectants
Medical devices disinfectors MEC
 AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of
(exempt from
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premarket review Disinfectants

unless indicated for  AOAC 6.3.02:2006 Official Method 955.17 Fungicidal activity of
high level disinfection Disinfectants Using Trichophyton Mentagrophytes
or for use on  AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against
endoscopes and Salmonella Choleraesuis, Use-Dilution Method
accessories)  AOAC 6.2.04:2013 Official Method 955.15, Testing Disinfectants Against
Medical devices cleaners MDZ II Staphylococcus Aureus, Use-Dilution Method
 AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against
High level disinfection
Pseudomonas Aeruginosa, Use-Dilution Method
reprocessing instrument for OUJ II
ultrasonic transducers, mist

High level disinfection

reprocessing instrument for
PSW II
ultrasonic transducers,
liquid
II. Ultraviolet (UV) Disinfecting Devices

UV radiation chamber
OSZ II
disinfection devices,
For the purposes of this guidance, FDA recommends that manufacturers of air
III. Air Purifiers
purifiers evaluate or perform the following:
Medical recirculation air 1. Demonstration of a 4 log reduction (through a combination of capture or
FRF II
cleaner destruction) of claimed particulates.
2. If intended for use against bacteria, effectiveness against representative
gram positive and gram negative species.
3. If intended for use related to SARS-CoV-2, effectiveness against a
Medical UV air purifier FRA II representative virus
4. If the device generates ozone, the maximum acceptable level of ozone per
21 CFR 801.415.
If intended for use in areas that have a sterile field or controlled air flow, a risk
assessment to address turbulent air flow and/or potential site contamination.

Table 4: Labeling Modifications for Sterilizers, Disinfectant Devices, and Air Purifiers:
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FDA RECOMMENDED LABELING MODIFICATIONS LABELING IMPACT (Yes/No)

IFU Art Work
1. A clear description of the available data on the device’s new indications or functions related to SARS-
Yes
CoV-2 or co-existing conditions, such as:
Yes (indication
a) Device performance; and
statement)
b) Potential risks (e.g., risk of UV exposure)
2. A clear distinction delineating FDA-cleared or FDA-approved indications from those that are not FDA-
clared or FDA-approved. In addition, FDA recommends the labeling include a general statement about Yes Yes
changes that have not been cleared by FDA.
3. For all disinfectant devices, a clear statement of the level of disinfection. Yes Yes
4. For UV disinfecting devices: Yes Yes
a) A caution that UV disinfection will reduce the number of pathogens on the device, but it will not
Yes No
eliminate them completely.
b) A statement that the device is an adjunct to currently existing reprocessing practices and not a
Yes No
replacement or modification to such practices.
c) A statement regarding the time, distance, and maximum area over which the device has been
Yes No
evaluated for effectiveness.
d) An appropriate UV hazard warning label. Yes Yes
e) Identification of the expected UV lamp operational life and instructions for procedures on
Yes No
replacement of the UV lamp when needed.
f) Procedures to follow if the UV lamp malfunctions or fails. Yes No
g) Description of the preparation of equipment or the room for disinfection Yes No

h) A statement that the equipment intended to be disinfected is UV compatible. Yes No

i) Identification of the UV dose. Yes No

 Modifications for Other category of devices that are not having significant impact
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The below are not having significant impact for emerging regulations (general use of masks and other PPE items)

DEVICE TYPE/ DESCRIPTION PROPOSED LABELING RECOMMENDATIONS/CHANGES IMPACT

CATEGORY IFU LABEL
3. Enforcement Policy for Infusion Pumps and Accessories (Emergency Use Authorization)
 Labeling of This enforcement policy  Clear description of new indications/functions/information on the Yes Yes
Modified described and applies to the performance & potential risks/ Clear distinction on FDA cleared & not cleared
Devices indications.
following infusion pumps &
their accessories used to treat  Adequate instructions on indicated environment(s) changes (label should
highlight the changes from previous version. Ex. Design changes may impact
patients who require
on MR safe/unsafe/conditional.
continuous infusion therapy
 EUAs for Products currently not marketed in the US, FDA recommends providing the Yes Yes
during the COVID-19
Infusion Pumps following information.
emergency.
 Contact information, name and place of business, email address, contact
E.g., Class II devices of; information for U.S agent, including proprietary/ brand name, model number,
and marketing authorization in the country/region.
o Infusion Pumps,
o Patient- controlled analgesia  A copy of the product labeling; containing information.
(PCA) Infusion Pump, o Device’s current marketing authorization in another regulatory jurisdictions.
o Infusion Pump Accessories, Ex. EU CE Mark, TGA, Health Canada, Japan along with copy of marketing
o Infusion Safety Management authorization letter/certificate/relevant corresponding information.
Software,  Device is designed with a power supply that is compatible with United States
o Other Class II infusion stands & necessary information for healthcare professionals, other
sets/devices. individuals, and emergency contact details.
4.Enforcement Policy for Face Masks and Respirators
 Face Masks Face masks &respirators meet Product labeling includes accurate description and list of body contacting Yes Yes
Intended for a device definition (for medical materials (which does not include any drugs or biologics & reduced risk of use) &
Medical UDI requirements.
purpose use by health care
Purpose that
are NOT professionals) under section
Intended to 201(h) of the Federal
Provide Liquid regulations.
Barrier
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Protection No federal regulations applied

for non-medical purpose
items.
 Face Shields Devices are comply with Product labeling includes accurate description and list of body contacting Yes Yes
Intended for a standards of Occupational materials (items doesn’t causes flammability, or product meets Class I or Class II
Medical Safety and Health flammability requirements) & undue risk statement to public health emergency.
Purpose
Administration (OSHA) and also
follow QSR & UDI requirements
of FDA.
5. FDA’s Intended Approach for EUAs for Face Masks and Respirators (Emergency Use Authorization)
 EUAs for Face These EUAs are intended to  Face mask & respirator currently not marketed in the US, FDA recommends
Masks Intended help increase availability of below information:
for a Medical o Contact information, name and place of business, email address, contact
these devices to front-line
Purpose, information for U.S. agent, including proprietary/ brand name, model
 Surgical Face personnel during the public
number, and marketing authorization in the country/region.
Masks and health emergency used by
 A copy of the product labeling including device marketing authorization status
 N95 Respirators healthcare professionals in another regulatory jurisdiction (including certification number, if available).

EMA recommendation of use of OFF-LABEL drugs

Off-label medicines of anaesthetics, antibiotics, Due to shortage of certain medicines in member states being used NA NA
muscle relaxants, and medicines used in the to treat COVID-19 patients, EMA given relaxation to market those products with
COVID therapy. closely monitoring.
"Off-label" means the medication is being used in a manner not specified in
the FDA's approved packaging label, or insert.