Deciding When To Submit a 510(k) for a Change to an Existing Device; Guidance for Industry and Food and Drug Administration Staff; Availability, 49375-49377 [2017-23197]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
and expedite the review of breakthrough
technologies.
The Breakthrough Devices Program
also supersedes the Priority Review
Program, which implemented statutory
criteria for granting priority review to
PMA submissions for medical devices,
applied those criteria to other types of
premarket submissions for medical
devices, and included standard
procedures to achieve an efficient
priority review process.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Breakthrough Devices Program;
Draft Guidance for Industry and Food
and Drug Administration Staff.’’ 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.
sradovich on DSK3GMQ082PROD with NOTICES
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by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/default.htm or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Breakthrough Devices Program’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1833 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 807, subpart E have been
approved under OMB control number
0910–0120; the collections of
information for De Novo classification
requests have been approved under
OMB control number 0910–0844; the
VerDate Sep<11>2014
22:06 Oct 24, 2017
Jkt 244001
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
part 814, subparts A through E, have
been approved under OMB control
number 0910–0231; the collections of
information in 21 CFR part 814, subpart
H, have been approved under OMB
control number 0910–0332; the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073; the
collections of information in 21 CFR
part 822 have been approved under
OMB control number 0910–0449; and
the collections of information regarding
‘‘Requests for Feedback on Medical
Device Submissions’’ have been
approved under OMB control number
0910–0756.
Dated: October 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–23195 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–2011–D–0453]
Deciding When To Submit a 510(k) for
a 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 Change to an
Existing Device.’’ FDA is issuing this
final guidance document to clarify when
a change in a legally marketed medical
device would require that a
manufacturer submit a premarket
notification (510(k)) to FDA. This
guidance document supersedes
‘‘Deciding When to Submit a 510(k) for
a Change to an Existing Device,’’ issued
January 10, 1997. FDA is correcting an
error in the docket number assigned to
the ‘‘Deciding When to Submit a 510(k)
for a Change to an Existing Device’’
notice of availability when it published
in the Federal Register (81 FR 52443,
August 8, 2016). The docket number
currently is FDA–2016–D–2021. FDA is
changing the docket number to FDA–
2011–D–0453. This action is
administrative in nature and is being
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
49375
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–
2011–D–0453 for ‘‘Deciding When to
Submit a 510(k) for a 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.
E:\FR\FM\25OCN1.SGM
25OCN1
sradovich on DSK3GMQ082PROD with NOTICES
49376
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
• 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
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 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
VerDate Sep<11>2014
22:06 Oct 24, 2017
Jkt 244001
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:
Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring,
MD 20993–0002, 301–796–6527; 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
(§ 807.81(a)(3) (21 CFR 807.81(a)(3)).
This guidance will aid manufacturers of
medical devices who intend to modify
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 modification
exceeds the regulatory threshold of
§ 807.81(a)(3) for submission and
clearance of a new 510(k).
This guidance supersedes the original
‘‘Deciding When to Submit a 510(k) for
a Change to an Existing Device,’’ issued
on January 10, 1997. That guidance
provided the Agency’s interpretation of
whether the modification exceeds the
regulatory threshold of § 807.81(a)(3),
with principles and points for
manufacturers to consider in analyzing
how changes in devices may affect
safety or effectiveness and determining
whether a new 510(k) must be
submitted for a particular type of
change. This final guidance preserves
the basic format and content of the
original, with updates to add clarity.
The added clarity is intended to
increase consistent interpretations of the
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
guidance by FDA staff and
manufacturers.
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 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.
The recommendations discussed in this
guidance for evaluating when a change
to an existing device would trigger the
requirement that a manufacturer submit
a new 510(k) to the Agency are
consistent with least burdensome
principles (Refs. 1 and 2). The least
burdensome provision concerning
510(k)s states that FDA ‘‘shall only
request information that is necessary
. . .’’ and ‘‘shall consider the least
burdensome means of demonstrating
substantial equivalence . . .’’ (see
section 513(i)(1)(D)(i) of the FD&C Act).
While not changing the standard for
substantial equivalence, this provision
states that FDA shall only request the
‘‘minimum required information’’
necessary to support a determination of
substantial equivalence (see sections
513(i)(1)(D)(ii)–(iii) of the FD&C Act).
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 Software Change to an
Existing Device’’ to aid manufacturers of
medical devices who intend to make
software changes to an existing device
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).
FDA considered comments received
on the draft guidance that appeared in
the Federal Register of August 8, 2016.
FDA revised the guidance as
appropriate in response to the
comments.
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 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
E:\FR\FM\25OCN1.SGM
25OCN1
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices
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/default.htm or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Deciding When to Submit a 510(k)
for a Change to an Existing Device’’ may
send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1500054 to
identify the guidance you are
requesting.
sradovich on DSK3GMQ082PROD with NOTICES
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 have been approved under
OMB control number 0910–0437; and
the collections of information in 21 CFR
parts 801 and 809 are approved under
OMB control number 0910–0485.
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. 2017–23197 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–2011–N–0655]
Animal Generic Drug User Fee Act;
Recommendations; Request for
Comments; Extension of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; request
for comments; extension of comment
period.
ACTION:
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.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of the
Animal Generic Drug User Fee Act
(AGDUFA) reauthorization draft
recommendations and extending the
comment period to allow interested
persons 30 days to submit comments on
these draft recommendations.
DATES: FDA is extending the comment
period on the AGDUFA reauthorization
and draft recommendations. Submit
either electronic or written comments
on the draft recommendations by
November 24, 2017.
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 24,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 24, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
VerDate Sep<11>2014
22:06 Oct 24, 2017
Jkt 244001
SUMMARY:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
49377
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–
2011–N–0655 for ‘‘Animal Generic Drug
User Fee Act; Recommendations;
Request for Comments; Extension of
Comment Period’’ Received 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
E:\FR\FM\25OCN1.SGM
25OCN1
]]>Agencies
[Federal Register Volume 82, Number 205 (Wednesday, October 25, 2017)]
[Notices]
[Pages 49375-49377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23197]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0453]
Deciding When To Submit a 510(k) for a 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 Change to an Existing Device.'' FDA is issuing this final
guidance document to clarify when a change in a legally marketed
medical device would require that a manufacturer submit a premarket
notification (510(k)) to FDA. This guidance document supersedes
``Deciding When to Submit a 510(k) for a Change to an Existing
Device,'' issued January 10, 1997. FDA is correcting an error in the
docket number assigned to the ``Deciding When to Submit a 510(k) for a
Change to an Existing Device'' notice of availability when it published
in the Federal Register (81 FR 52443, August 8, 2016). The docket
number currently is FDA-2016-D-2021. FDA is changing the docket number
to FDA-2011-D-0453. 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-2011-D-0453 for ``Deciding When to Submit a 510(k) for a 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.
[[Page 49376]]
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 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: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527;
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 modify 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 modification exceeds the regulatory threshold of
Sec. 807.81(a)(3) for submission and clearance of a new 510(k).
This guidance supersedes the original ``Deciding When to Submit a
510(k) for a Change to an Existing Device,'' issued on January 10,
1997. That guidance provided the Agency's interpretation of whether the
modification exceeds the regulatory threshold of Sec. 807.81(a)(3),
with principles and points for manufacturers to consider in analyzing
how changes in devices may affect safety or effectiveness and
determining whether a new 510(k) must be submitted for a particular
type of change. This final guidance preserves the basic format and
content of the original, with updates to add clarity. The added clarity
is intended to increase consistent interpretations of the guidance by
FDA staff and manufacturers.
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 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. The recommendations discussed in this guidance for evaluating
when a change to an existing device would trigger the requirement that
a manufacturer submit a new 510(k) to the Agency are consistent with
least burdensome principles (Refs. 1 and 2). The least burdensome
provision concerning 510(k)s states that FDA ``shall only request
information that is necessary . . .'' and ``shall consider the least
burdensome means of demonstrating substantial equivalence . . .'' (see
section 513(i)(1)(D)(i) of the FD&C Act). While not changing the
standard for substantial equivalence, this provision states that FDA
shall only request the ``minimum required information'' necessary to
support a determination of substantial equivalence (see sections
513(i)(1)(D)(ii)-(iii) of the FD&C Act).
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 Software Change to an Existing Device'' to aid
manufacturers of medical devices who intend to make software changes to
an existing device 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).
FDA considered comments received on the draft guidance that
appeared in the Federal Register of August 8, 2016. FDA revised the
guidance as appropriate in response to the comments.
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
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
[[Page 49377]]
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/default.htm or https://www.regulations.gov. Persons unable to download
an electronic copy of ``Deciding When to Submit a 510(k) for a 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 1500054 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 have been approved under
OMB control number 0910-0437; and the collections of information in 21
CFR parts 801 and 809 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. 2017-23197 Filed 10-24-17; 8:45 am]
BILLING CODE 4164-01-P
