Deciding When To Submit a 510(k) for a Software Change to an Existing Device; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 52441-52443 [2016-18714]
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52441
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/
route
NDA 007961 .......
BENTYL ...........
10 milligrams (mg)/5 milliliters
(mL).
Syrup; Oral .......
Aptalis Pharma US, Inc.
NDA 011721 .......
NDA 016418 .......
NEPTAZANE ...
INDERAL .........
Dicyclomine Hydrochloride
(HCl).
Methazolamide
Propranolol HCl
25 mg; 50 mg .............................
10 mg; 20 mg; 40 mg; 60 mg ....
Tablet; Oral ......
Tablet; Oral ......
NDA 021410 .......
AVANDAMET ...
Metformin HCl;
Rosiglitazone
Maleate.
Tablet; Oral ......
NDA 021494 .......
NDA 050505 .......
AXID .................
GARAMYCIN ...
ANDA 061716 ....
GARAMYCIN ...
ANDA 061739 ....
GARAMYCIN ...
ANDA 080745 ....
ARISTOCORT
and
ARISTOCORT A.
KENALOG ........
Nizatidine .........
Gentamicin Sulfate.
Gentamicin Sulfate.
Gentamicin Sulfate.
Triamcinolone
Acetonide.
500 mg/Equivalent to (EQ) 2 mg
base; 500 mg/EQ 4 mg base;
1 g/EQ 2 mg base; 1 g/EQ 4
mg base.
15 mg/mL ...................................
EQ 2 mg base/mL ......................
Lederle Laboratories.
Wyeth Pharmaceuticals, Inc., a
subsidiary of Pfizer Inc.
SmithKline Beecham (Cork) Ltd,
Ireland.
mstockstill on DSK3G9T082PROD with NOTICES
ANDA 083944 ....
Triamcinolone
Acetonide.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the Agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs and ANDAs listed in this
document are unaffected by the
discontinued marketing of the products
subject to those NDAs and ANDAs.
Additional ANDAs that refer to these
products may also be approved by the
Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for these
drug products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18707 Filed 8–5–16; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
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EQ 1 mg base/mL; EQ 40 mg
base/mL.
EQ 10 mg base/mL ....................
0.5% ...........................................
0.5% ...........................................
Solution; Oral ...
Injectable;
Intrathecal.
Injectable; Injection.
Injectable; Injection.
Ointment; Topical.
Braintree Laboratories, Inc.
Schering-Plough Corp.
Ointment; Topical.
Delcor Asset Corp.
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 Software Change to an Existing
Device; Draft 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 draft
guidance entitled ‘‘Deciding When to
Submit a 510(k) for a Software Change
to an Existing Device.’’ FDA is issuing
this draft 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. This draft
guidance is not final nor is it in effect
at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 7,
2016.
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Applicant
ADDRESSES:
Schering-Plough Corp.
Schering-Plough Corp.
Astellas Pharma US, Inc.
You may submit comments
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:
E:\FR\FM\08AUN1.SGM
08AUN1
mstockstill on DSK3G9T082PROD with NOTICES
52442
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 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 Division of Dockets
Management 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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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 draft 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 to 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.
This draft guidance specifically
addresses software design and
technology modifications. This draft
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 (see, 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).
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).
FOR FURTHER INFORMATION CONTACT:
II. Significance of Guidance
SUPPLEMENTARY INFORMATION:
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 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.
I. Background
III. Electronic Access
A premarket notification (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
those that constitute major changes or
modifications in the intended use of the
device (21 CFR 807.81(a)(3)). This
guidance, when finalized, will aid
manufacturers of medical devices who
intend to make a software modification
to a 510(k)-cleared device or a
preamendments device subject to 510(k)
(i.e., ‘‘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).
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 ‘‘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.
Linda Ricci, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1314, Silver Spring,
MD 20993–0002, 301–796–6325,
linda.ricci@fda.hhs.gov; or Stephen
Ripley, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993, 240–402–7911.
PO 00000
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Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
IV. Paperwork Reduction Act of 1995
This draft 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.
Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18714 Filed 8–5–16; 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 Change to an Existing Device; Draft
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 draft
guidance entitled ‘‘Deciding When to
Submit a 510(k) for a Change to an
Existing Device.’’ FDA is issuing this
draft 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. When
finalized, this document will supersede
‘‘Deciding When to Submit a 510(k) for
a Change to an Existing Device’’ issued
January 10, 1997. This draft guidance is
not final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 7,
2016.
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
ADDRESSES:
You may submit comments
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 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
Division of Dockets Management
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
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
52443
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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 draft 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.
E:\FR\FM\08AUN1.SGM
08AUN1
Agencies
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52441-52443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18714]
-----------------------------------------------------------------------
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 Software Change to an
Existing Device; Draft 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 draft guidance entitled ``Deciding When to
Submit a 510(k) for a Software Change to an Existing Device.'' FDA is
issuing this draft 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. This draft guidance is
not final nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 7, 2016.
ADDRESSES: You may submit comments 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:
[[Page 52442]]
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 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 Division of
Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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 draft 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 to 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. 1314, Silver Spring, MD 20993-0002, 301-796-6325,
linda.ricci@fda.hhs.gov; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911.
SUPPLEMENTARY INFORMATION:
I. Background
A premarket notification (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 those that constitute major changes or modifications in
the intended use of the device (21 CFR 807.81(a)(3)). This guidance,
when finalized, will aid manufacturers of medical devices who intend to
make a software modification to a 510(k)-cleared device or a
preamendments device subject to 510(k) (i.e., ``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).
This draft guidance specifically addresses software design and
technology modifications. This draft 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 (see,
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).
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. 807.81(a)(3)
for submission and clearance of a new 510(k).
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 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.
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/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 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.
[[Page 52443]]
IV. Paperwork Reduction Act of 1995
This draft 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.
Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18714 Filed 8-5-16; 8:45 am]
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