Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel, 22846-22848 [2018-10563]
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83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
May 17, 2018.’’
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83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
May 17, 2018.’’
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Dated: May 12, 2018.
Richard E. Ashooh,
Assistant Secretary for Export
Administration.
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
Medical Devices; Exemption From
Premarket Notification: Class II
Devices; Surgical Apparel
Food and Drug Administration,
HHS.
Final order.
The Food and Drug
Administration (FDA or Agency) is
publishing this final order to exempt
certain surgical apparel from premarket
notification requirements, subject to
conditions and limitations. FDA is
limiting the exemption to single-use,
disposable respiratory protective
devices (RPD) used in a healthcare
setting and worn by healthcare
personnel during procedures to protect
both the patient and the healthcare
personnel from the transfer of
microorganisms, body fluids, and
particulate material. These devices,
commonly referred to as N95 filtering
facepiece respirators (FFRs) and surgical
N95 respirators (herein collectively
referred to as N95s) are currently
regulated by FDA under product code
MSH. This exemption will decrease
regulatory burden on the medical device
amozie on DSK3GDR082PROD with RULES
16:58 May 16, 2018
Aftin Ross, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave, Bldg. 66, Rm. 5402, Silver Spring,
MD 20993, 301–796–5679, email:
Aftin.Ross@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
SUMMARY:
VerDate Sep<11>2014
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FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2017–N–4919]
ACTION:
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industry and will eliminate private costs
and expenditures required to comply
with certain Federal regulations. All
other class II devices classified under
FDA’s surgical apparel classification
regulation continue to be subject to
premarket notification requirements.
FDA is also amending the codified
language for the surgical apparel devices
classification regulation to reflect this
final determination.
DATES: This order is effective May 17,
2018.
[FR Doc. 2018–10528 Filed 5–16–18; 8:45 am]
AGENCY:
83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
May 17, 2018.’’
Jkt 244001
Section 510(k) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360(k)) and the implementing
regulations, 21 CFR part 807, subpart E,
require persons who intend to market a
new device to submit and obtain
clearance of a premarket notification
(510(k)) containing information that
allows FDA to determine whether the
new device is ‘‘substantially equivalent’’
within the meaning of section 513(i) of
the FD&C Act (21 U.S.C. 360c(i)) to a
legally marketed device that does not
require premarket approval.
The 21st Century Cures Act (Pub. L.
114–255) (Cures Act) was signed into
law on December 13, 2016. Section 3054
of the Cures Act amended section
510(m) of the FD&C Act. As amended,
section 510(m)(2) of the FD&C Act
provides that, 1 calendar day after the
date of publication of the final list under
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paragraph (1)(B), FDA may exempt a
class II device from the requirement to
submit a report under section 510(k) of
the FD&C Act upon its own initiative or
a petition of an interested person, if
FDA determines that a report under
section 510(k) is not necessary to assure
the safety and effectiveness of the
device. To do so, FDA must publish in
the Federal Register notice of its intent
to exempt the device, or of the petition,
and provide a 60-calendar day period
for public comment. Within 120 days
after the issuance of the notice, FDA
shall publish an order in the Federal
Register that sets forth its final
determination regarding the exemption
of the device that was the subject of the
notice.
II. Factors FDA May Consider for
Exemption
There are a number of factors FDA
may consider to determine whether a
510(k) is necessary to provide
reasonable assurance of the safety and
effectiveness of a class II device. These
factors are discussed in the January 21,
1998, Federal Register notice (63 FR
3142) and subsequently in the guidance
the Agency issued on February 19, 1998,
entitled ‘‘Procedures for Class II Device
Exemptions From Premarket
Notification; Guidance for Industry and
CDRH Staff’’ (‘‘Class II 510(k)
Exemption Guidance’’) (Ref. 1).
Accordingly, FDA generally considers
the following factors to determine
whether a 510(k) is necessary for class
II devices: (1) The device does not have
a significant history of false or
misleading claims or of risks associated
with inherent characteristics of the
device; (2) characteristics of the device
necessary for its safe and effective
performance are well established; (3)
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17MYR1
Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations
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changes in the device that could affect
safety and effectiveness will either: (a)
Be readily detectable by users by visual
examination or other means such as
routine testing, before causing harm, or
(b) not materially increase the risk of
injury, incorrect diagnosis, or ineffective
treatment; and (4) any changes to the
device would not be likely to result in
a change in the device’s classification.
FDA may also consider that, even when
exempting devices, these devices would
still be subject to the limitations on
exemptions.
III. Device Description
FDA, upon its own initiative, is
exempting N95 filtering facepiece
respirators (FFRs) and surgical N95
respirators (herein collectively referred
to as N95s) from 510(k), subject to the
conditions and limitations described in
this section. FDA considers N95s to be
a subset of ‘‘surgical apparel’’ intended
to be worn by healthcare personnel to
protect both the patient and the
healthcare personnel from transfer of
microorganisms, body fluids, and
particulate material. As a result, these
devices fall under the generic name
‘‘surgical apparel’’ and are classified in
§ 878.4040(b)(1) (21 CFR
878.4040(b)(1)). In the Federal Register
of June 24, 1988 (53 FR 23856), FDA
issued a final rule classifying surgical
apparel into class II (special controls).
We are now exempting a subset of
surgical apparel devices currently
regulated under product code MSH from
510(k) review. FDA has assessed the
need for 510(k) against the criteria laid
out in the Class II 510(k) Exemption
Guidance and determined that these
devices no longer require a 510(k) to
provide reasonable assurance of safety
and effectiveness. However, this
exemption is limited and FDA’s
determination only applies to those
N95s under the conditions listed below.
FDA has a Memorandum of
Understanding (MOU) with the Centers
for Disease Control and Prevention
(CDC), acting through its National
Institute for Occupational Safety and
Health (NIOSH), regarding oversight of
N95s (Ref. 2). This agreement outlines
the structure through which both
Agencies will regulate N95s exempt
from 510(k). The MOU between NIOSH
and FDA is now effective as part of this
final order.
Although FDA and CDC share a
common public health mission, the
Agencies have different statutory
authorities and the distinct terminology
could lead to confusion among
stakeholders. In order to clearly identify
the devices that are subject to this
document, as well as the corresponding
VerDate Sep<11>2014
16:58 May 16, 2018
Jkt 244001
MOU, the following definitions are
provided for the devices that are now
exempt.
The N95 FFR is a single-use
disposable, half-mask respiratory
protective device that covers the user’s
airway (nose and mouth) and offers
protection from particulate materials at
an N95 filtration efficiency level per 42
CFR 84.181. Such an N95 FFR used in
a healthcare setting is a class II device,
regulated by FDA under § 878.4040.
The surgical N95 respirator is a
single-use, disposable respiratory
protective device used in a healthcare
setting that is worn by HCP during
procedures to protect both the patient
and HCP from the transfer of
microorganisms, body fluids, and
particulate material at an N95 filtration
efficiency level per 42 CFR 84.181. The
surgical N95 respirator is also a class II
device, regulated by FDA under
§ 878.4040.
In the Federal Register of November
30, 2017 (82 FR 56763), FDA published
a proposed order announcing its intent
to exempt N95s from premarket
notification [510(k)] requirements,
subject to certain conditions and
limitations, and provided opportunity
for interested persons to submit
comments by January 30, 2018. After
reviewing the comments received
(summarized in section IV), FDA is now
providing its final determination for
N95s by exempting this type of device
from 510(k) requirements, subject to
certain conditions and limitations as
identified in this final order. FDA is also
amending the codified language for the
surgical apparel devices classification
regulation to reflect this final
determination. Persons with pending
510(k) submissions for devices that are
now exempt from 510(k), subject to the
conditions and limitations, should
withdraw their submissions.
IV. Comments on the Proposed
Exemption and FDA’s Response
In response to the November 2017
proposed order announcing FDA’s
intent to exempt N95s from 510(k)
requirements, FDA received
submissions from four commenters—
two from regulated industry, one from
an industry association, and one from a
consumer. Three commenters supported
the implementation of the MOU with
the CDC, acting through NIOSH,
regarding oversight of N95s and
exemption from 510(k) for this device
type. FDA agrees with the three
commenters that the exemption from
510(k) requirements will streamline the
oversight of N95s without
compromising the public health.
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22847
One commenter requested that these
devices still be subject to 510(k)
requirements to ensure safety of people
using the disposable respiratory
protective devices. Further, the
commenter indicated that FDA’s
proposal should not be finalized
because the sterility of these devices can
greatly affect those working in the
health field and patients being treated,
and if these devices are not properly
inspected or regulated, diseases could
spread more easily from person to
person. The commenter noted that
because these devices will be used by
surgical staff, it is even more important
that the devices be inspected because
surgery can involve open wounds or
open body cavities, making it easier to
spread disease or bodily fluids.
FDA notes in response to this
commenter that N95s subject to this
exemption from 510(k) are not provided
sterile to the user. While FDA has
exempted these devices from 510(k), the
scientific evidence necessary to legally
market N95s within this exemption has
not changed. The majority of this testing
has traditionally been reviewed by
NIOSH. The conditions and limitations
of exemption that FDA has identified in
section V of this final order and
§ 878.4040(b)(1) will provide reasonable
assurance of safety and effectiveness for
N95s. Unless an N95 meets the mutually
agreed upon threshold evaluation
criteria and approval criteria and has
NIOSH approval, the device would still
be subject to 510(k) review.
Accordingly, FDA did not modify the
exemption or conditions and limitations
of exemption proposed for N95s in
response to this comment.
V. Conditions and Limitations of
Exemption
As described in the MOU, the
following conditions must be met for
N95s to be 510(k) exempt: (1)
application submitted to NIOSH is
determined not to exceed the CDC’s and
FDA’s mutually agreed upon threshold
evaluation criteria and (2) such
applicants must have met approval
criteria and have NIOSH approval. N95s
with applications that meet the
mutually agreed upon threshold
evaluation criteria and approval criteria
and remain approved by NIOSH are
exempt from FDA’s 510(k)
requirements. Unless an N95 meets the
mutually agreed upon threshold
evaluation criteria and approval criteria
and has NIOSH approval, the device is
subject to 510(k) review; this includes
devices with applications pending
NIOSH review, as well as devices with
no submitted applications. The
threshold evaluation criteria are
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Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations
codified into the conditions and
limitations of exemption described in
§ 878.4040(b)(1).
N95s are the only devices included
within the scope of the MOU. As such,
this exemption only applies to devices
currently regulated by FDA under
product code MSH. This exemption
does not affect any other subset of
surgical apparel classified under
§ 878.4040. In addition to being subject
to the general limitations to the
exemptions found in 21 CFR 878.9 and
the conditions of exemption identified
in this final order, these devices will
also remain subject to current good
manufacturing practices and other
general controls under the FD&C Act.
An exemption from the requirement of
510(k) does not mean that the device is
exempt from any other statutory or
regulatory requirements, unless such
exemption is explicitly provided by
order or regulation.
This exemption will decrease
regulatory burdens on the medical
device industry and will eliminate
private costs and expenditures required
to comply with Federal regulations.
Specifically, regulated industry will no
longer have to invest time and resources
in 510(k)s, including preparation of
documents and data for submission to
FDA, payment of user fees associated
with 510(k) submissions, and
responding to questions and requests for
additional information from FDA during
510(k) review for devices in this
exempted device type, subject to the
conditions and limitations of the
exemption.
VI. Paperwork Reduction Act of 1995
This order refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart, E have been
approved under OMB control number
0910–0120.
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VII. References
The following references are on
display in the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
VerDate Sep<11>2014
16:58 May 16, 2018
Jkt 244001
1. FDA Guidance, ‘‘Procedures for Class II
Device Exemptions from Premarket
Notification, Guidance for Industry and
CDRH Staff,’’ February 19, 1998, available at
https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
UCM080199.pdf.
2. ‘‘Memorandum of Understanding
Between the Food and Drug Administration,
Center for Devices and Radiological Health,
and the Centers for Disease Control and
Prevention, National Institute for
Occupational Safety and Health, National
Personal Protective Technology Laboratory,’’
available at https://www.fda.gov/AboutFDA/
PartnershipsCollaborations/
MemorandaofUnderstandingMOUs/
DomesticMOUs/.
(B) Demonstrate the ability of the
device to resist penetration by fluids,
such as blood and body fluids, at a
velocity consistent with the intended
use of the device.
(iii) NIOSH approved under its
regulation.
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Dated: May 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10563 Filed 5–16–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF STATE
List of Subjects in 21 CFR Part 878
22 CFR Parts 50 and 51
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321
et seq., as amended) and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 878 is
amended as follows:
[Public Notice 10417]
PART 878—GENERAL AND PLASTIC
SURGERY DEVICES
SUMMARY:
1. The authority citation for part 878
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. In § 878.4040, paragraph (b)(1) is
revised to read as follows:
■
§ 878.4040
Surgical apparel.
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(b) Classification. (1) Class II (special
controls) for surgical gowns and surgical
masks. A surgical N95 respirator or N95
filtering facepiece respirator is not
exempt if it is intended to prevent
specific diseases or infections, or it is
labeled or otherwise represented as
filtering surgical smoke or plumes,
filtering specific amounts of viruses or
bacteria, reducing the amount of and/or
killing viruses, bacteria, or fungi, or
affecting allergenicity, or it contains
coating technologies unrelated to
filtration (e.g., to reduce and or kill
microorganisms). Surgical N95
respirators and N95 filtering facepiece
respirators are exempt from the
premarket notification procedures in
subpart E of part 807 of this chapter
subject to § 878.9, and the following
conditions for exemption:
(i) The user contacting components of
the device must be demonstrated to be
biocompatible.
(ii) Analysis and nonclinical testing
must:
(A) Characterize flammability and be
demonstrated to be appropriate for the
intended environment of use; and
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Passports
Department of State.
Final rule; stay.
AGENCY:
ACTION:
The Department of State
published a final rule in the Federal
Register on May 11, 2018, amending the
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stays the amendments in the May 11
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DATES: Effective May 17, 2018,
§§ 50.7(d), 50.11(b), 51.4(g)(1) and (8),
51.60(h) and (i), 51.62, 51.65, 51.66, and
51.70 through 51.74, are stayed until
June 10, 2018.
FOR FURTHER INFORMATION CONTACT:
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Passport Services, (202) 485–6500,
PassportRules@state.gov. Hearing- or
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SUPPLEMENTARY INFORMATION: The
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Administrative practice and
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[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Rules and Regulations]
[Pages 22846-22848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10563]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. FDA-2017-N-4919]
Medical Devices; Exemption From Premarket Notification: Class II
Devices; Surgical Apparel
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
this final order to exempt certain surgical apparel from premarket
notification requirements, subject to conditions and limitations. FDA
is limiting the exemption to single-use, disposable respiratory
protective devices (RPD) used in a healthcare setting and worn by
healthcare personnel during procedures to protect both the patient and
the healthcare personnel from the transfer of microorganisms, body
fluids, and particulate material. These devices, commonly referred to
as N95 filtering facepiece respirators (FFRs) and surgical N95
respirators (herein collectively referred to as N95s) are currently
regulated by FDA under product code MSH. This exemption will decrease
regulatory burden on the medical device industry and will eliminate
private costs and expenditures required to comply with certain Federal
regulations. All other class II devices classified under FDA's surgical
apparel classification regulation continue to be subject to premarket
notification requirements. FDA is also amending the codified language
for the surgical apparel devices classification regulation to reflect
this final determination.
DATES: This order is effective May 17, 2018.
FOR FURTHER INFORMATION CONTACT: Aftin Ross, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave, Bldg. 66, Rm. 5402, Silver Spring, MD 20993, 301-796-5679, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Statutory Background
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part
807, subpart E, require persons who intend to market a new device to
submit and obtain clearance of a premarket notification (510(k))
containing information that allows FDA to determine whether the new
device is ``substantially equivalent'' within the meaning of section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device
that does not require premarket approval.
The 21st Century Cures Act (Pub. L. 114-255) (Cures Act) was signed
into law on December 13, 2016. Section 3054 of the Cures Act amended
section 510(m) of the FD&C Act. As amended, section 510(m)(2) of the
FD&C Act provides that, 1 calendar day after the date of publication of
the final list under paragraph (1)(B), FDA may exempt a class II device
from the requirement to submit a report under section 510(k) of the
FD&C Act upon its own initiative or a petition of an interested person,
if FDA determines that a report under section 510(k) is not necessary
to assure the safety and effectiveness of the device. To do so, FDA
must publish in the Federal Register notice of its intent to exempt the
device, or of the petition, and provide a 60-calendar day period for
public comment. Within 120 days after the issuance of the notice, FDA
shall publish an order in the Federal Register that sets forth its
final determination regarding the exemption of the device that was the
subject of the notice.
II. Factors FDA May Consider for Exemption
There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently
in the guidance the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions From Premarket
Notification; Guidance for Industry and CDRH Staff'' (``Class II 510(k)
Exemption Guidance'') (Ref. 1). Accordingly, FDA generally considers
the following factors to determine whether a 510(k) is necessary for
class II devices: (1) The device does not have a significant history of
false or misleading claims or of risks associated with inherent
characteristics of the device; (2) characteristics of the device
necessary for its safe and effective performance are well established;
(3)
[[Page 22847]]
changes in the device that could affect safety and effectiveness will
either: (a) Be readily detectable by users by visual examination or
other means such as routine testing, before causing harm, or (b) not
materially increase the risk of injury, incorrect diagnosis, or
ineffective treatment; and (4) any changes to the device would not be
likely to result in a change in the device's classification. FDA may
also consider that, even when exempting devices, these devices would
still be subject to the limitations on exemptions.
III. Device Description
FDA, upon its own initiative, is exempting N95 filtering facepiece
respirators (FFRs) and surgical N95 respirators (herein collectively
referred to as N95s) from 510(k), subject to the conditions and
limitations described in this section. FDA considers N95s to be a
subset of ``surgical apparel'' intended to be worn by healthcare
personnel to protect both the patient and the healthcare personnel from
transfer of microorganisms, body fluids, and particulate material. As a
result, these devices fall under the generic name ``surgical apparel''
and are classified in Sec. 878.4040(b)(1) (21 CFR 878.4040(b)(1)). In
the Federal Register of June 24, 1988 (53 FR 23856), FDA issued a final
rule classifying surgical apparel into class II (special controls). We
are now exempting a subset of surgical apparel devices currently
regulated under product code MSH from 510(k) review. FDA has assessed
the need for 510(k) against the criteria laid out in the Class II
510(k) Exemption Guidance and determined that these devices no longer
require a 510(k) to provide reasonable assurance of safety and
effectiveness. However, this exemption is limited and FDA's
determination only applies to those N95s under the conditions listed
below.
FDA has a Memorandum of Understanding (MOU) with the Centers for
Disease Control and Prevention (CDC), acting through its National
Institute for Occupational Safety and Health (NIOSH), regarding
oversight of N95s (Ref. 2). This agreement outlines the structure
through which both Agencies will regulate N95s exempt from 510(k). The
MOU between NIOSH and FDA is now effective as part of this final order.
Although FDA and CDC share a common public health mission, the
Agencies have different statutory authorities and the distinct
terminology could lead to confusion among stakeholders. In order to
clearly identify the devices that are subject to this document, as well
as the corresponding MOU, the following definitions are provided for
the devices that are now exempt.
The N95 FFR is a single-use disposable, half-mask respiratory
protective device that covers the user's airway (nose and mouth) and
offers protection from particulate materials at an N95 filtration
efficiency level per 42 CFR 84.181. Such an N95 FFR used in a
healthcare setting is a class II device, regulated by FDA under Sec.
878.4040.
The surgical N95 respirator is a single-use, disposable respiratory
protective device used in a healthcare setting that is worn by HCP
during procedures to protect both the patient and HCP from the transfer
of microorganisms, body fluids, and particulate material at an N95
filtration efficiency level per 42 CFR 84.181. The surgical N95
respirator is also a class II device, regulated by FDA under Sec.
878.4040.
In the Federal Register of November 30, 2017 (82 FR 56763), FDA
published a proposed order announcing its intent to exempt N95s from
premarket notification [510(k)] requirements, subject to certain
conditions and limitations, and provided opportunity for interested
persons to submit comments by January 30, 2018. After reviewing the
comments received (summarized in section IV), FDA is now providing its
final determination for N95s by exempting this type of device from
510(k) requirements, subject to certain conditions and limitations as
identified in this final order. FDA is also amending the codified
language for the surgical apparel devices classification regulation to
reflect this final determination. Persons with pending 510(k)
submissions for devices that are now exempt from 510(k), subject to the
conditions and limitations, should withdraw their submissions.
IV. Comments on the Proposed Exemption and FDA's Response
In response to the November 2017 proposed order announcing FDA's
intent to exempt N95s from 510(k) requirements, FDA received
submissions from four commenters--two from regulated industry, one from
an industry association, and one from a consumer. Three commenters
supported the implementation of the MOU with the CDC, acting through
NIOSH, regarding oversight of N95s and exemption from 510(k) for this
device type. FDA agrees with the three commenters that the exemption
from 510(k) requirements will streamline the oversight of N95s without
compromising the public health.
One commenter requested that these devices still be subject to
510(k) requirements to ensure safety of people using the disposable
respiratory protective devices. Further, the commenter indicated that
FDA's proposal should not be finalized because the sterility of these
devices can greatly affect those working in the health field and
patients being treated, and if these devices are not properly inspected
or regulated, diseases could spread more easily from person to person.
The commenter noted that because these devices will be used by surgical
staff, it is even more important that the devices be inspected because
surgery can involve open wounds or open body cavities, making it easier
to spread disease or bodily fluids.
FDA notes in response to this commenter that N95s subject to this
exemption from 510(k) are not provided sterile to the user. While FDA
has exempted these devices from 510(k), the scientific evidence
necessary to legally market N95s within this exemption has not changed.
The majority of this testing has traditionally been reviewed by NIOSH.
The conditions and limitations of exemption that FDA has identified in
section V of this final order and Sec. 878.4040(b)(1) will provide
reasonable assurance of safety and effectiveness for N95s. Unless an
N95 meets the mutually agreed upon threshold evaluation criteria and
approval criteria and has NIOSH approval, the device would still be
subject to 510(k) review. Accordingly, FDA did not modify the exemption
or conditions and limitations of exemption proposed for N95s in
response to this comment.
V. Conditions and Limitations of Exemption
As described in the MOU, the following conditions must be met for
N95s to be 510(k) exempt: (1) application submitted to NIOSH is
determined not to exceed the CDC's and FDA's mutually agreed upon
threshold evaluation criteria and (2) such applicants must have met
approval criteria and have NIOSH approval. N95s with applications that
meet the mutually agreed upon threshold evaluation criteria and
approval criteria and remain approved by NIOSH are exempt from FDA's
510(k) requirements. Unless an N95 meets the mutually agreed upon
threshold evaluation criteria and approval criteria and has NIOSH
approval, the device is subject to 510(k) review; this includes devices
with applications pending NIOSH review, as well as devices with no
submitted applications. The threshold evaluation criteria are
[[Page 22848]]
codified into the conditions and limitations of exemption described in
Sec. 878.4040(b)(1).
N95s are the only devices included within the scope of the MOU. As
such, this exemption only applies to devices currently regulated by FDA
under product code MSH. This exemption does not affect any other subset
of surgical apparel classified under Sec. 878.4040. In addition to
being subject to the general limitations to the exemptions found in 21
CFR 878.9 and the conditions of exemption identified in this final
order, these devices will also remain subject to current good
manufacturing practices and other general controls under the FD&C Act.
An exemption from the requirement of 510(k) does not mean that the
device is exempt from any other statutory or regulatory requirements,
unless such exemption is explicitly provided by order or regulation.
This exemption will decrease regulatory burdens on the medical
device industry and will eliminate private costs and expenditures
required to comply with Federal regulations. Specifically, regulated
industry will no longer have to invest time and resources in 510(k)s,
including preparation of documents and data for submission to FDA,
payment of user fees associated with 510(k) submissions, and responding
to questions and requests for additional information from FDA during
510(k) review for devices in this exempted device type, subject to the
conditions and limitations of the exemption.
VI. Paperwork Reduction Act of 1995
This order refers to previously approved collections of information
found in FDA regulations. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in 21 CFR part 807, subpart, E have been approved under
OMB control number 0910-0120.
VII. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. FDA Guidance, ``Procedures for Class II Device Exemptions
from Premarket Notification, Guidance for Industry and CDRH Staff,''
February 19, 1998, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.
2. ``Memorandum of Understanding Between the Food and Drug
Administration, Center for Devices and Radiological Health, and the
Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health, National Personal Protective
Technology Laboratory,'' available at https://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/.
List of Subjects in 21 CFR Part 878
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq., as amended) and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
1. The authority citation for part 878 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. In Sec. 878.4040, paragraph (b)(1) is revised to read as follows:
Sec. 878.4040 Surgical apparel.
* * * * *
(b) Classification. (1) Class II (special controls) for surgical
gowns and surgical masks. A surgical N95 respirator or N95 filtering
facepiece respirator is not exempt if it is intended to prevent
specific diseases or infections, or it is labeled or otherwise
represented as filtering surgical smoke or plumes, filtering specific
amounts of viruses or bacteria, reducing the amount of and/or killing
viruses, bacteria, or fungi, or affecting allergenicity, or it contains
coating technologies unrelated to filtration (e.g., to reduce and or
kill microorganisms). Surgical N95 respirators and N95 filtering
facepiece respirators are exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to Sec.
878.9, and the following conditions for exemption:
(i) The user contacting components of the device must be
demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate
for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by
fluids, such as blood and body fluids, at a velocity consistent with
the intended use of the device.
(iii) NIOSH approved under its regulation.
* * * * *
Dated: May 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10563 Filed 5-16-18; 8:45 am]
BILLING CODE 4164-01-P