Benefit-Risk Factors To Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) With Different Technological Characteristics; Guidance for Industry and Food and Drug Administration Staff; Availability, 48439-48441 [2018-20771]
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V. Reference
The following reference is on display
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(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and is
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daltland on DSKBBV9HB2PROD with NOTICES
1. Ridley, D.B., H.G. Grabowski, and J.L. Moe,
‘‘Developing Drugs for Developing
Countries,’’ Health Affairs, vol. 25, no. 2,
pp. 313–324, 2006, available at: https://
faculty.fuqua.duke.edu/∼willm/HSM_
RA/Documents/HA2006_Ridley_
Vouchers.pdf.
Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20772 Filed 9–24–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0900]
Benefit-Risk Factors To Consider
When Determining Substantial
Equivalence in Premarket Notifications
(510(k)) With Different Technological
Characteristics; Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the final
guidance entitled ‘‘Benefit-Risk Factors
to Consider When Determining
Substantial Equivalence in Premarket
Notifications (510(k)) with Different
Technological Characteristics.’’ This
guidance document describes factors
FDA considers when evaluating the
benefit-risk profile of a device in
comparison to a predicate device in a
510(k) when the device has the same
intended use as the predicate device,
and different technological
characteristics that do not raise different
questions of safety and effectiveness.
This guidance can be helpful in
situations when there is an increase in
risk and increase or equivalent benefit,
or a decrease in benefit and a decrease
or equivalent risk when comparing a
new device to a predicate device. FDA
developed this guidance to improve the
predictability, consistency, and
transparency of the 510(k) premarket
review process.
DATES: The announcement of the
guidance is published in the Federal
Register on September 25, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
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48439
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–D–0900 for ‘‘Benefit-Risk Factors
to Consider When Determining
Substantial Equivalence in Premarket
Notifications (510(k)) with Different
Technological Characteristics.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
E:\FR\FM\25SEN1.SGM
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daltland on DSKBBV9HB2PROD with NOTICES
48440
Federal Register / Vol. 83, No. 186 / Tuesday, September 25, 2018 / Notices
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Benefit-Risk Factors
to Consider When Determining
Substantial Equivalence in Premarket
Notifications (510(k)) with Different
Technological Characteristics’’ to the
Office of the Center Director, Guidance
and Policy Development, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach, and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT:
Ifeanyi Uwemedimo, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1609, Silver Spring,
MD 20993–0002, 240–402–5243.
SUPPLEMENTARY INFORMATION:
I. Background
Submitters seeking 510(k) submission
must demonstrate to FDA that the new
device is substantially equivalent (SE) to
a legally marketed predicate device
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17:40 Sep 24, 2018
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using the criteria identified in section
513(i) of the FD&C Act (21 U.S.C.
360c(i)). To find a new device SE to a
predicate device, FDA must first find
that the devices have the same intended
use. FDA must then determine that the
devices have the same technological
characteristics, or that any differences in
technological characteristics do not
raise different questions of safety and
effectiveness, and that the new device is
as safe and effective as the predicate
device.
FDA evaluates differences in
technological characteristics between
the new device and the predicate device
to determine their effect on substantial
equivalence (i.e., whether the new
device is as safe and effective as the
predicate device). Under section
513(a)(2) of the FD&C Act, FDA
determines the safety and effectiveness
of a device by weighing any probable
benefit to health from the use of the
device against any probable risk of
injury or illness from such use, among
other relevant factors.
This guidance document is consistent
with FDA guidance entitled ‘‘The 510(k)
Program: Evaluating Substantial
Equivalence in Premarket Notifications
[510(k)]’’ (https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
UCM284443), issued on July 28, 2014,
and provides additional clarification on
factors that FDA takes into
consideration when evaluating the
benefit-risk profile of a new device in
comparison to a predicate device when
FDA must evaluate whether the new
device is substantially equivalent to the
predicate device. More specifically, in
situations where (1) an increase in risk
and increase or equivalent benefit or (2)
a decrease in benefit and a decrease or
equivalent risk when comparing a new
device to a predicate device, FDA
recommends that a benefit-risk
assessment be conducted to provide
further perspective regarding whether
the new device is substantially
equivalent to the predicate. FDA does
not recommend a benefit-risk
assessment in situations where there is
(1) an increase in risk and decrease in
benefit or (2) decrease or equivalent risk
and increase or equivalent benefit
because benefit-risk factors are not
warranted to determine whether a
device is substantially equivalent. This
guidance does not add new regulatory
requirements for submitters, it does not
change the 510(k) premarket review
standard, nor does it create extra or new
burdens on what has traditionally been
submitted in 510(k)s.
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In the Federal Register on July 15,
2014 (79 FR 41289), FDA announced the
availability of the draft guidance and
interested parties were invited to
comment by October 14, 2014. FDA has
considered all the public comments
received prior to finalizing this
guidance.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on benefit-risk factors
to consider when determining
substantial equivalence in premarket
notifications (510(k)) with different
technological characteristics. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/default.htm or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Benefit-Risk Factors to Consider
When Determining Substantial
Equivalence in Premarket Notifications
(510(k)) with Different Technological
Characteristics’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1818 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
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 the following FDA
regulations and guidance have been
approved by OMB as listed in the
following table:
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OMB control
No.
21 CFR part or guidance
Topic
807, subpart E ............................................................................
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff’’.
803 ..............................................................................................
Premarket notification .................................................................
Q-submissions ............................................................................
0910–0120
0910–0756
Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor
reporting.
0910–0437
Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
[FR Doc. 2018–20771 Filed 9–24–18; 8:45 am]
Electronic Submissions
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0559]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Public Health
Service Guideline on Infectious
Disease Issues in Xenotransplantation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to this notice. This notice
solicits comments on the collection of
information contained in the Public
Health Service (PHS) guideline entitled
‘‘PHS Guideline on Infectious Disease
Issues in Xenotransplantation’’ dated
January 19, 2001.
DATES: Submit either electronic or
written comments on the collection of
information by November 26, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 26,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 26, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
SUMMARY:
daltland on DSKBBV9HB2PROD with NOTICES
48441
VerDate Sep<11>2014
17:40 Sep 24, 2018
Jkt 244001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0559 for ‘‘PHS Guideline on
Infectious Disease Issues in
Xenotransplantation.’’ Received
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comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
E:\FR\FM\25SEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48439-48441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20771]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0900]
Benefit-Risk Factors To Consider When Determining Substantial
Equivalence in Premarket Notifications (510(k)) With Different
Technological Characteristics; Guidance for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the final guidance entitled ``Benefit-Risk Factors
to Consider When Determining Substantial Equivalence in Premarket
Notifications (510(k)) with Different Technological Characteristics.''
This guidance document describes factors FDA considers when evaluating
the benefit-risk profile of a device in comparison to a predicate
device in a 510(k) when the device has the same intended use as the
predicate device, and different technological characteristics that do
not raise different questions of safety and effectiveness. This
guidance can be helpful in situations when there is an increase in risk
and increase or equivalent benefit, or a decrease in benefit and a
decrease or equivalent risk when comparing a new device to a predicate
device. FDA developed this guidance to improve the predictability,
consistency, and transparency of the 510(k) premarket review process.
DATES: The announcement of the guidance is published in the Federal
Register on September 25, 2018.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-D-0900 for ``Benefit-Risk Factors to Consider When Determining
Substantial Equivalence in Premarket Notifications (510(k)) with
Different Technological Characteristics.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this
[[Page 48440]]
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Benefit-Risk Factors to Consider When Determining Substantial
Equivalence in Premarket Notifications (510(k)) with Different
Technological Characteristics'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Ifeanyi Uwemedimo, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1609, Silver Spring, MD 20993-0002, 240-
402-5243.
SUPPLEMENTARY INFORMATION:
I. Background
Submitters seeking 510(k) submission must demonstrate to FDA that
the new device is substantially equivalent (SE) to a legally marketed
predicate device using the criteria identified in section 513(i) of the
FD&C Act (21 U.S.C. 360c(i)). To find a new device SE to a predicate
device, FDA must first find that the devices have the same intended
use. FDA must then determine that the devices have the same
technological characteristics, or that any differences in technological
characteristics do not raise different questions of safety and
effectiveness, and that the new device is as safe and effective as the
predicate device.
FDA evaluates differences in technological characteristics between
the new device and the predicate device to determine their effect on
substantial equivalence (i.e., whether the new device is as safe and
effective as the predicate device). Under section 513(a)(2) of the FD&C
Act, FDA determines the safety and effectiveness of a device by
weighing any probable benefit to health from the use of the device
against any probable risk of injury or illness from such use, among
other relevant factors.
This guidance document is consistent with FDA guidance entitled
``The 510(k) Program: Evaluating Substantial Equivalence in Premarket
Notifications [510(k)]'' (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443), issued on
July 28, 2014, and provides additional clarification on factors that
FDA takes into consideration when evaluating the benefit-risk profile
of a new device in comparison to a predicate device when FDA must
evaluate whether the new device is substantially equivalent to the
predicate device. More specifically, in situations where (1) an
increase in risk and increase or equivalent benefit or (2) a decrease
in benefit and a decrease or equivalent risk when comparing a new
device to a predicate device, FDA recommends that a benefit-risk
assessment be conducted to provide further perspective regarding
whether the new device is substantially equivalent to the predicate.
FDA does not recommend a benefit-risk assessment in situations where
there is (1) an increase in risk and decrease in benefit or (2)
decrease or equivalent risk and increase or equivalent benefit because
benefit-risk factors are not warranted to determine whether a device is
substantially equivalent. This guidance does not add new regulatory
requirements for submitters, it does not change the 510(k) premarket
review standard, nor does it create extra or new burdens on what has
traditionally been submitted in 510(k)s.
In the Federal Register on July 15, 2014 (79 FR 41289), FDA
announced the availability of the draft guidance and interested parties
were invited to comment by October 14, 2014. FDA has considered all the
public comments received prior to finalizing this guidance.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on benefit-risk factors to consider when
determining substantial equivalence in premarket notifications (510(k))
with different technological characteristics. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download
an electronic copy of ``Benefit-Risk Factors to Consider When
Determining Substantial Equivalence in Premarket Notifications (510(k))
with Different Technological Characteristics'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number 1818 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information. 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
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:
[[Page 48441]]
------------------------------------------------------------------------
OMB control
21 CFR part or guidance Topic No.
------------------------------------------------------------------------
807, subpart E.................... Premarket 0910-0120
notification.
``Requests for Feedback on Medical Q-submissions....... 0910-0756
Device Submissions: The Pre-
Submission Program and Meetings
with Food and Drug Administration
Staff''.
803............................... Medical Devices; 0910-0437
Medical Device
Reporting;
Manufacturer
reporting, importer
reporting, user
facility reporting,
distributor
reporting.
------------------------------------------------------------------------
Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20771 Filed 9-24-18; 8:45 am]
BILLING CODE 4164-01-P
