Deciding When To Submit a 510(k) for a Software Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff; Availability, 49382-49384 [2017-23196]
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49382
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
Practice Inspection Mutual Recognition
Agreement. All other commitments
related to pre-approval inspections will
remain the same as ADUFA III.
The Agency will review and act on 90
percent of qualifying Animal Drug
Availability Act (ADAA) combination
medicated feed applications within 60
days after the submission date when all
of the following conditions are met:
• Basic regulatory requirements for an
ADAA combination medicated feed
application has been met as outlined in
21 CFR 514.4(c)(2)(ii).
• A presubmission conference has
been conducted and either:
Æ No data (no tissue residue noninterference study is required) are
needed and this agreement is
documented in the memorandum of
conference for the presubmission
conference; or
Æ A justification for not conducting a
tissue residue non-interference study
has been submitted, reviewed, and
found acceptable under an
investigational new animal drug (INAD),
prior to the submission of the ADAA
combination medicated feed
application; or
Æ A tissue residue non-interference
study has been submitted, reviewed,
and found acceptable under an INAD,
prior to the submission of the ADAA
combination medicated feed
application.
• No effectiveness or target animal
safety data are required.
• No manufacturing data
requirements—sponsor can address in
meeting assay non-interference, but data
submission is not required.
• All other information is referenced
to previous drug experience reports.
• Sponsor makes submission and it
includes: Representative (Blue Bird)
labeling, Veterinary Feed Directive (if
applicable).
• Includes a request for categorical
exclusion from the need to prepare an
environmental assessment (EA); i.e., no
EA required.
• Reference to presubmission
conference.
• Right of reference (if applicable) to
NADA(s) not owned by the filing
sponsor of the ADAA combination
medicated feed application has been
received by the Agency.
The Agency will review and act on 90
percent of ADAA combination
medicated feed applications within 100
days for those applications accepted for
the 60-day timeframe and there is a
need for minor amendments.
If any of the above conditions cannot
be met, the ADAA combination
medicated feed application performance
metric will be placed in the original
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NADA application cohort with a 180day review timeframe.
The Agency will review and act on 90
percent of resubmissions of previously
completed Environmental Impact
technical sections within 60 days after
the submission date where:
• A categorical exclusion was issued;
• All other technical sections have
been submitted; and
• Information contained in the other
technical sections reveals a change in
the conditions of use of the previously
issued categorical exclusion.
The Agency will conduct 90 percent
of qualifying presubmission conferences
within a 60-day timeframe when all of
the following conditions are met:
• All background materials, including
presentations, have been submitted, and
• A complete agenda has been agreed
upon by the Agency and the sponsor.
A sponsor and the Agency can
mutually agree to exclude a particular
presubmission conference from this
performance goal. If a sponsor accepts a
date beyond the 60-day timeframe for
their scheduling purposes or is unable
to meet with the Agency on Agency
available dates, the submission will be
excluded from the presubmission
conference cohort.
The Agency will commence 90
percent of tissue residue method
demonstrations within 120 days of
completion of the 3-hour meeting
process or within 200 days from the
receipt of a submission that supports a
single laboratory validation tissue
residue method demonstration.
B. Inflation Adjuster and Workload
Adjuster
The inflation adjuster will remain the
same as for ADUFA III.
The workload adjustment will
continue to be calculated per Center for
Veterinary Medicine Program Policy
and Procedures Manual 1243.3022,
except that, for purposes of calculating
the workload adjustment, it has been
agreed to reset the base years to fiscal
year (FY) 2014 through FY 2018. There
will be no workload adjustment for FY
2019. Workload adjustments are onetime adjustments and are calculated
annually.
C. Offset Provision and Excess
Collections
The proposal adds financial flexibility
by eliminating the final year offset of
over collections provision and making
any excess collections available to
enhance the review process in real time.
The proposal provides authority for the
Secretary of Health and Human Services
(the Secretary) when setting fees to
reduce a calculated workload
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adjustment up to the amount of excess
collections in the second preceding
fiscal year. The first fiscal year this
provision could be applied while setting
fees is FY 2021. Likewise, the proposal
also provides authority to the Secretary
to reduce an increase in fees to recover
a shortfall in collections in a preceding
year (after 2018) by any remaining prior
year excess collections not already
applied for purposes of reducing fee
increases.
D. Impact of ADUFA IV Enhancements
on User Fee Revenue
The FY 2019 baseline for ADUFA IV
is $30,331,240, which includes a
$400,000 one-time cost for information
technology enhancement. For each year
from FY 2020 through FY 2023, the
annual statutory revenue amounts
established in section 741(b) of the
FD&C Act (21 U.S.C. 379j–21(b)) will be
further adjusted by the inflation
adjuster, the workload adjuster, if
applicable, and will include $900,000
per year for tissue method trials.
The total 5-year revenue planned for
ADUFA I was $47,000,000. The total 5year revenue planned for ADUFA II was
$98,000,000. The total 5-year revenue
planned for ADUFA III was
$114,000,000. It is estimated that the
total 5-year revenue for ADUFA IV will
be $150,000,000.
The fee revenue distribution in
ADUFA IV will remain the same as
ADUFA III: 20 percent from application
fees; 27 percent from product fees; 26
percent from establishment fees; and 27
percent from sponsor fees.
Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–23172 Filed 10–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2021]
Deciding When To Submit a 510(k) for
a Software Change to an Existing
Device; 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
guidance entitled ‘‘Deciding When to
Submit a 510(k) for a Software Change
SUMMARY:
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Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
to an Existing Device.’’ FDA is issuing
this final guidance document to clarify
when a software change in a legally
marketed medical device would require
that a manufacturer submit a premarket
notification (510(k)) to FDA. FDA is
correcting an error in the docket number
assigned to the ‘‘Deciding When to
Submit a 510(k) for a Software Change
to an Existing Device’’ notice of
availability when it published in the
Federal Register (81 FR 52441, August
8, 2016). The docket number currently
is FDA–2011–D–0453. FDA is changing
the docket number to FDA–2016–D–
2021. This action is administrative in
nature and is being taken to avoid any
potential confusion in the docket.
DATES: The announcement of the
guidance is published in the Federal
Register on October 25, 2017.
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’’).
sradovich on DSK3GMQ082PROD with NOTICES
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
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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–
2016–D–2021 for ‘‘Deciding When to
Submit a 510(k) for a Software Change
to an Existing Device.’’ 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
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
PO 00000
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49383
from the internet. See the
section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Deciding When to
Submit a 510(k) for a Software Change
to an Existing Device’’ 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:
Linda Ricci, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G634, Silver Spring,
MD 20993–0002, 301–796–6325,
linda.ricci@fda.hhs.gov; and Stephen
Ripley, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
SUPPLEMENTARY INFORMATION
I. Background
A 510(k) is required when a legally
marketed device subject to 510(k)
requirements is about to be significantly
changed or modified in design,
components, method of manufacture, or
intended use. Significant changes or
modifications are those that could
significantly affect the safety or
effectiveness of the device, or major
changes or modifications in the
intended use of the device
(§ 807.81(a)(3) (21 CFR 807.81(a)(3)).
This guidance will aid manufacturers of
medical devices who intend to make a
software modification to a 510(k)cleared device or other device subject to
510(k) requirements, such as a
preamendments device or a device that
was granted marketing authorization via
the De Novo classification process
under section 513(f)(2) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c(f)(2)) (also
referred to together as ‘‘existing
devices’’), during the process of
deciding whether the software
modification exceeds the regulatory
threshold of § 807.81(a)(3) for
submission and clearance of a new
510(k).
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Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
This guidance specifically addresses
software design and technology
modifications, including firmware. This
guidance does not apply to software for
which the Agency has stated in
guidance that it does not intend to
enforce compliance with applicable
regulatory controls (e.g., ‘‘Mobile
Medical Applications: Guidance for
Industry and FDA Staff,’’ issued
February 9, 2015, available on the
internet at https://www.fda.gov/
downloads/medicaldevices/.../
ucm263366.pdf) and software that does
not meet the definition of a medical
device at section 201(h) of the FD&C Act
(21 U.S.C. 321(h)).
In the Federal Register on August 8,
2016, FDA announced the availability of
the draft guidance and interested parties
were requested to comment by
November 7, 2016. FDA considered
comments received on the draft
guidance and revised the guidance as
appropriate.
This guidance is not intended to
implement significant policy changes to
FDA’s current thinking on when
submission of a new 510(k) is required
for a software change to an existing
device. Rather, the intent of this
guidance is to enhance the
predictability, consistency, and
transparency of the ‘‘when to submit’’
decision-making process by providing a
least burdensome approach, and
describing in greater detail the
regulatory framework, policies, and
practices underlying such a decision,
specifically as it relates to software
changes. The recommendations
discussed in this guidance for
evaluating when a software change to an
existing device would trigger the
requirement that a manufacturer submit
a new 510(k) to the Agency are
consistent with the least burdensome
principles (Refs. 1 and 2). This guidance
applies the least burdensome principles,
in part, by reliance on risk management
and the quality system regulation (21
CFR part 820) to determine whether
submission of a new 510(k) is required
for a software change to an existing
device.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of the guidance document
entitled ‘‘Deciding When to Submit a
510(k) for a Change to an Existing
Device,’’ to aid manufacturers of
medical devices who intend to make
non-software changes to an existing
device during the process of deciding
whether the modification exceeds the
regulatory threshold of § 807.81(a)(3) for
submission and clearance of a new
510(k).
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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 ‘‘Deciding When to
Submit a 510(k) for a Software Change
to an Existing Device.’’ 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.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Persons unable to
download an electronic copy of
‘‘Deciding When to Submit a 510(k) for
a Software Change to an Existing
Device’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number
1500055 to identify the guidance you
are requesting.
IV. Paperwork Reduction Act of 1995
This guidance 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 820 are approved under
OMB control number 0910–0073; the
collections of information in 21 CFR
part 807, subpart E are approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 803 are approved under OMB
control number 0910–0437; and the
collections of information in 21 CFR
parts 801 are approved under OMB
control number 0910–0485.
V. 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
PO 00000
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through Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. ‘‘The Least Burdensome Provisions of the
FDA Modernization Act of 1997:
Concept and Principles,’’ dated October
4, 2002, available at: https://
www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm085999.pdf.
2. ‘‘Suggested Format for Developing and
Responding to Deficiencies in
Accordance with the Least Burdensome
Provisions of FDAMA,’’ dated November
2, 2000, available at: https://
www.fda.gov/downloads/Medical
Devices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm073680.pdf.
Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–23196 Filed 10–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Notice of Interest Rate on Overdue
Debts
Section 30.18 of the Department of
Health and Human Services’ claims
collection regulations (45 CFR part 30)
provides that the Secretary shall charge
an annual rate of interest, which is
determined and fixed by the Secretary
of the Treasury after considering private
consumer rates of interest on the date
that the Department of Health and
Human Services becomes entitled to
recovery. The rate cannot be lower than
the Department of Treasury’s current
value of funds rate or the applicable rate
determined from the ‘‘Schedule of
Certified Interest Rates with Range of
Maturities’’ unless the Secretary waives
interest in whole or part, or a different
rate is prescribed by statute, contract, or
repayment agreement. The Secretary of
the Treasury may revise this rate
quarterly. The Department of Health and
Human Services publishes this rate in
the Federal Register.
The current rate of 93⁄4%, as fixed by
the Secretary of the Treasury, is certified
for the quarter ended September 30,
2017. This rate is based on the Interest
Rates for Specific Legislation, ‘‘National
Health Services Corps Scholarship
Program (42 U.S.C. 254o(b)(1)(A))’’ and
‘‘National Research Service Award
Program (42 U.S.C. 288(c)(4)(B)).’’ This
interest rate will be applied to overdue
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]]>Agencies
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49382-49384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23196]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2021]
Deciding When To Submit a 510(k) for a Software Change to an
Existing Device; 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 guidance entitled ``Deciding When to Submit a
510(k) for a Software Change
[[Page 49383]]
to an Existing Device.'' FDA is issuing this final guidance document to
clarify when a software change in a legally marketed medical device
would require that a manufacturer submit a premarket notification
(510(k)) to FDA. FDA is correcting an error in the docket number
assigned to the ``Deciding When to Submit a 510(k) for a Software
Change to an Existing Device'' notice of availability when it published
in the Federal Register (81 FR 52441, August 8, 2016). The docket
number currently is FDA-2011-D-0453. FDA is changing the docket number
to FDA-2016-D-2021. This action is administrative in nature and is
being taken to avoid any potential confusion in the docket.
DATES: The announcement of the guidance is published in the Federal
Register on October 25, 2017.
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-2016-D-2021 for ``Deciding When to Submit a 510(k) for a Software
Change to an Existing Device.'' 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 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
``Deciding When to Submit a 510(k) for a Software Change to an Existing
Device'' 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: Linda Ricci, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G634, Silver Spring, MD 20993-0002, 301-796-6325,
[email protected]; and Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
A 510(k) is required when a legally marketed device subject to
510(k) requirements is about to be significantly changed or modified in
design, components, method of manufacture, or intended use. Significant
changes or modifications are those that could significantly affect the
safety or effectiveness of the device, or major changes or
modifications in the intended use of the device (Sec. 807.81(a)(3) (21
CFR 807.81(a)(3)). This guidance will aid manufacturers of medical
devices who intend to make a software modification to a 510(k)-cleared
device or other device subject to 510(k) requirements, such as a
preamendments device or a device that was granted marketing
authorization via the De Novo classification process under section
513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360c(f)(2)) (also referred to together as ``existing
devices''), during the process of deciding whether the software
modification exceeds the regulatory threshold of Sec. 807.81(a)(3) for
submission and clearance of a new 510(k).
[[Page 49384]]
This guidance specifically addresses software design and technology
modifications, including firmware. This guidance does not apply to
software for which the Agency has stated in guidance that it does not
intend to enforce compliance with applicable regulatory controls (e.g.,
``Mobile Medical Applications: Guidance for Industry and FDA Staff,''
issued February 9, 2015, available on the internet at https://www.fda.gov/downloads/medicaldevices/.../ucm263366.pdf) and software
that does not meet the definition of a medical device at section 201(h)
of the FD&C Act (21 U.S.C. 321(h)).
In the Federal Register on August 8, 2016, FDA announced the
availability of the draft guidance and interested parties were
requested to comment by November 7, 2016. FDA considered comments
received on the draft guidance and revised the guidance as appropriate.
This guidance is not intended to implement significant policy
changes to FDA's current thinking on when submission of a new 510(k) is
required for a software change to an existing device. Rather, the
intent of this guidance is to enhance the predictability, consistency,
and transparency of the ``when to submit'' decision-making process by
providing a least burdensome approach, and describing in greater detail
the regulatory framework, policies, and practices underlying such a
decision, specifically as it relates to software changes. The
recommendations discussed in this guidance for evaluating when a
software change to an existing device would trigger the requirement
that a manufacturer submit a new 510(k) to the Agency are consistent
with the least burdensome principles (Refs. 1 and 2). This guidance
applies the least burdensome principles, in part, by reliance on risk
management and the quality system regulation (21 CFR part 820) to
determine whether submission of a new 510(k) is required for a software
change to an existing device.
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of the guidance document entitled ``Deciding When to
Submit a 510(k) for a Change to an Existing Device,'' to aid
manufacturers of medical devices who intend to make non-software
changes to an existing device during the process of deciding whether
the modification exceeds the regulatory threshold of Sec.
[thinsp]807.81(a)(3) for submission and clearance of a new 510(k).
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 ``Deciding When to Submit a 510(k) for a
Software Change to an Existing Device.'' 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. Guidance
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Persons unable to
download an electronic copy of ``Deciding When to Submit a 510(k) for a
Software Change to an Existing Device'' may send an email request to
[email protected] to receive an electronic copy of the
document. Please use the document number 1500055 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance 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 820 are approved under OMB
control number 0910-0073; the collections of information in 21 CFR part
807, subpart E are approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 803 are approved under OMB
control number 0910-0437; and the collections of information in 21 CFR
parts 801 are approved under OMB control number 0910-0485.
V. 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 Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. ``The Least Burdensome Provisions of the FDA Modernization Act of
1997: Concept and Principles,'' dated October 4, 2002, available at:
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085999.pdf.
2. ``Suggested Format for Developing and Responding to Deficiencies
in Accordance with the Least Burdensome Provisions of FDAMA,'' dated
November 2, 2000, available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073680.pdf.
Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23196 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P
