Medical Devices; Custom Devices; Technical Amendment, 70339-70340 [2016-24438]
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Federal Register / Vol. 81, No. 197 / Wednesday, October 12, 2016 / Rules and Regulations
in the List of Items Controlled section to
read as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
7E994 ‘‘Technology,’’ n.e.s., for the
‘‘development,’’ ‘‘production’’, or ‘‘use’’
of navigation, airborne communication,
and other avionics equipment.
Food and Drug Administration
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[Docket No. FDA–2016–N–2518]
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Medical Devices; Custom Devices;
Technical Amendment
List of Items Controlled
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Related Controls: N/A
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21 CFR Parts 807 and 812
AGENCY:
Food and Drug Administration,
HHS.
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Final rule; technical
amendment.
ACTION:
46. In Supplement No. 1 to part 774,
Category 8, ECCN 8A002 is amended by
adding a sentence to the end of the
Related Controls paragraph in the List of
Items Controlled section to read as
follows:
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8A002 Marine systems, equipment, ‘‘parts’’
and ‘‘components,’’ as follows (see List
of Items Controlled).
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List of Items Controlled
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Related Controls: * * * (5) Section 744.9
imposes a license requirement on
commodities described in 8A002.d if being
exported, reexported, or transferred (incountry) for use by a military end-user or
for incorporation into an item controlled
by ECCN 0A919.
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47. In Supplement No. 1 to part 774,
Category 9, ECCN 9A991 is amended by:
■ a. Removing the License Requirement
Notes paragraph in the License
Requirements section, and
■ b. Revising the Related Controls
paragraph in the List of Items Controlled
section.
The revision reads as follows:
■
9A991 ‘‘Aircraft’’, n.e.s., and gas turbine
engines not controlled by 9A001 or
9A101 and ‘‘parts’’ and ‘‘components,’’
n.e.s. (see List of Items Controlled).
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List of Items Controlled
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Related Controls: N/A
mstockstill on DSK3G9T082PROD with RULES
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Dated: September 15, 2016.
Kevin J. Wolf,
Assistant Secretary of Commerce for Export
Administration.
[FR Doc. 2016–24220 Filed 10–11–16; 8:45 am]
BILLING CODE 3510–33–P
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Jkt 241001
The Food and Drug
Administration (FDA or Agency) is
amending its regulations on the
definition of a custom device so as to
include new enumerated statutory
requirements for custom devices under
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) as amended by the
Food and Drug Administration Safety
and Innovation Act (FDASIA). This new
provision, under FDASIA, amends the
existing custom device exemption and
introduces new concepts and
procedures applicable to custom
devices. This action is being taken to
align the regulations with the FD&C Act.
DATES: This rule is effective October 12,
2016.
FOR FURTHER INFORMATION CONTACT:
Erica B. Payne, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5520, Silver Spring,
MD 20993, 301–796–3999.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
On July 9, 2012, section 617 of
FDASIA (Pub. L. 112–144), amended the
FD&C Act (21 U.S.C. 301 et seq.), to
require changes in the implementation
of the custom device exemption under
section 520(b) of the FD&C Act (21
U.S.C. 360j(b)) (Ref. 1). Under the
revised provision, as under the original
custom device exemption, a device that
meets the qualification of a custom
device is exempt from 510(k) and
Premarket Approval (PMA) submissions
under sections 514 and 515 of the FD&C
Act (21 U.S.C. 360d and 360e) (see also
§§ 807.85 and 812.3(b) (21 CFR 807.85
and 812.3(b)). Because of the
amendments to section 520(b) of the
FD&C Act, the current regulatory
definition for a custom device, set forth
in §§ 807.85(a) and 812.3(b), is no longer
consistent with the statute. This
technical amendment will correct the
regulations by revising the definition of
a custom device to restate the statute.
Under existing regulations at
§ 807.85(a), a custom device is exempt
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
70339
from premarket notification under
section 510(k) of the FD&C Act. In the
Federal Register of August 23, 1977 (42
FR 42520 at 42523), FDA published a
final rule establishing the form and
manner for 510(k) premarket
notifications, which identified a custom
device as an exemption from the
premarket approval requirement
because a principal purpose for
requiring 510(k) premarket notification
is absent. The final rule explained that
the exemption for manufacturers of
custom devices is intended to apply
only to those who are manufacturing a
custom device to fit the needs of a
particular patient, so the manufacturer
will not be required to file a premarket
notification for each particular device.
In the Federal Register of January 18,
1980 (45 FR 3732 at 3740), FDA
published a final rule setting forth the
rules and conditions under which
investigations for medical devices
involving human subjects may be
exempt from certain requirements of the
FD&C Act. The 1980 final rule provided
clarification for the definition of
‘‘custom devices’’ under § 812.3(b) for
Investigational Device Exemptions (IDE)
unless used to determine safety and
effectiveness for commercial
distribution. A device used to conduct
a clinical trial cannot qualify as a
custom device.
Section 520(b) of the FD&C Act, as
amended by section 617 of FDASIA,
changed some of the criteria to qualify
for the custom device exemption, which
is different from the criteria currently
described in the regulations. The
amendment to section 520(b) of the
FD&C Act states that a device will
qualify as a ‘‘custom device’’ by meeting
new enumerated statutory requirements,
including, among others, the following
for each device: (1) Is created or
modified in order to comply with the
order of an individual physician or
dentist (or other specially qualified
person); (2) necessarily deviates from an
otherwise applicable performance
standard under section 514 or
requirement under section 515 of the
FD&C Act; (3) is not generally available
in the United States in finished form
through labeling or advertising by the
manufacturer, importer, or distributor
for commercial distribution; (4) is
designed to treat a unique pathology or
physiological condition that no other
device is domestically available to treat;
(5) either (a) is intended to meet the
special needs of such physician or
dentist in the course of the professional
practice of such physician or dentist (or
other specially qualified person as
designated) in the course of their
professional practice or (b) is intended
E:\FR\FM\12OCR1.SGM
12OCR1
mstockstill on DSK3G9T082PROD with RULES
70340
Federal Register / Vol. 81, No. 197 / Wednesday, October 12, 2016 / Rules and Regulations
for use by an individual patient named
in the order of a physician or dentist (or
other specially qualified person as
designated); (6) is assembled from
components or manufactured and
finished on a case-by-case basis to
accommodate the unique needs of
individuals, physician, or dentist; and
(7) may have common, standardized
design characteristics, chemical and
material compositions, and
manufacturing processes as
commercially distributed devices (21
U.S.C. 360j(b)).
The new provisions for the custom
device exemption also include the
following limitations: (1) The device is
for the purpose of treating a
‘‘sufficiently rare condition, such that
conducting clinical investigations on
such device would be impractical;’’ (2)
the production of the device must be
‘‘limited to no more than five units per
year of a particular device type’’; and (3)
a manufacturer is required to submit an
annual report to FDA on the custom
devices it supplied.
This technical amendment to the
regulations for the custom device
exemption will ensure clarity and
consistency with the requirements of
the FD&C Act. Some manufacturers
might be unaware that certain medical
devices that they distribute as custom
devices do not meet the statutory
definition as currently described in the
regulations and are subject to premarket
review. Also, FDA issued the final
guidance entitled, ‘‘Custom Device
Exemption’’ (Ref. 2) explaining the new
statutory provisions for custom devices.
The guidance provides definitions of
certain terms used in connection with
the custom device exemption and
explains how FDA interprets the
devices that may qualify for the custom
device exemption under section 520(b)
of the FD&C Act. The guidance also
describes in further detail what
information should be submitted in an
annual report, and provides
recommendations on how to submit an
annual report for custom devices
distributed under the exemption (Ref.
2). FDA finds good cause for issuing this
amendment as a final rule without
notice and comment because this
amendment only corrects the
implementing regulation to restate the
statute (5 U.S.C. 553(b)(B)). ‘‘[W]hen
regulations merely restate the statute
they implement, notice-and-comment
procedures are unnecessary.’’ Gray
Panthers Advoc. Committee v. Sullivan,
936 F.2d 1284, 1291 (D.C. Cir. 1991).
The amendments to §§ 807.85(a) and
812.3(b) merely incorporate applicable
requirements of the FD&C Act, making
notice-and-comment procedures
VerDate Sep<11>2014
16:05 Oct 11, 2016
Jkt 241001
unnecessary in this case. Therefore,
publication of this document constitutes
final action on this change under the
Administrative Procedure Act (APA) (5
U.S.C. 553).
In addition, FDA finds good cause for
these amendments to become effective
on the date of publication of this action.
The APA allows an effective date less
than 30 days after publication as
‘‘provided by the agency for good cause
found and published with the rule’’ (5
U.S.C. 553(d)(3)). A delayed effective
date is unnecessary in this case because
the amendments to §§ 807.85 and
812.3(b) do not impose any new
regulatory requirements on affected
parties. As a result, affected parties do
not need time to prepare before the rule
takes effect. Therefore, FDA finds good
cause for this correction to become
effective on the date of publication of
this action.
II. References
The following references have been
placed on display in the Division of
Dockets Management (located at 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852), and may be seen by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday. (FDA has
verified the Web site address, but we are
not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.)
1. The Food and Drug Administration
Safety and Innovation Act, available at
https://www.fda.gov/
RegulatoryInformation/Legislation/
SignificantAmendmentstotheFDCAct/
FDASIA/ucm20027187.htm or at
https://www.congress.gov/112/plaws/
publ144/PLAW-112publ144.pdf.
2. Custom Device Exemption;
Guidance for Industry and Food and
Drug Administration Staff; September
24, 2014, available at https://
www.fda.gov/ucm/groups/fdagovpublic/@fdagov-meddev-gen/
documents/document/ucm415799.pdf.
PART 807—ESTABLISHMENT
REGISTRATION AND DEVICE LISTING
FOR MANUFACTURERS AND INTITIAL
IMPORTERS OF DEVICES
1. The authority citation for part 807
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
360, 360c, 360e, 360i, 360j, 371, 374, 381,
393; 42 U.S.C. 264, 271.
2. Section 807.85 is amended by
revising paragraph (a) introductory text
to read as follows:
■
§ 807.85 Exemption from premarket
notification.
(a) A custom device is exempt from
premarket notification requirements of
this subpart if the device is within the
meaning of section 520(b) of the Federal
Food, Drug, and Cosmetic Act.
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PART 812—INVESTIGATIONAL
DEVICE EXEMPTIONS
3. The authority citation for part 812
continues to read as follows:
■
Authority: 21 U.S.C. 331, 351, 352, 353,
355, 360, 360c-360f, 360h-360j, 371, 372, 374,
379e, 381, 382, 383; 42 U.S.C. 216, 241, 262,
263b-263n.
4. Section 812.3 is amended by
revising paragraph (b) to read as follows:
■
§ 812.3
Definitions.
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(b) A custom device means a device
within the meaning of section 520(b) of
the Federal Food, Drug, and Cosmetic
Act.
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Dated: October 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–24438 Filed 10–11–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF STATE
List of Subjects
22 CFR Part 121
21 CFR Part 807
[Public Notice: 9605]
Confidential business information,
Imports, Medical devices, Reporting and
recordkeeping requirements.
RIN 1400–AD32
21 CFR Part 812
Health records, Medical devices,
Medical research, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 807
and 812 are amended as follows:
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Amendment to the International Traffic
in Arms Regulations: Revision of U.S.
Munitions List Category XII
Department of State.
Final rule.
AGENCY:
ACTION:
As part of the President’s
Export Control Reform effort, the
Department of State amends the
International Traffic in Arms
Regulations (ITAR) by revising Category
SUMMARY:
E:\FR\FM\12OCR1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 197 (Wednesday, October 12, 2016)]
[Rules and Regulations]
[Pages 70339-70340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24438]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 807 and 812
[Docket No. FDA-2016-N-2518]
Medical Devices; Custom Devices; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
its regulations on the definition of a custom device so as to include
new enumerated statutory requirements for custom devices under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the
Food and Drug Administration Safety and Innovation Act (FDASIA). This
new provision, under FDASIA, amends the existing custom device
exemption and introduces new concepts and procedures applicable to
custom devices. This action is being taken to align the regulations
with the FD&C Act.
DATES: This rule is effective October 12, 2016.
FOR FURTHER INFORMATION CONTACT: Erica B. Payne, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5520, Silver Spring, MD 20993, 301-796-3999.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2012, section 617 of FDASIA (Pub. L. 112-144), amended
the FD&C Act (21 U.S.C. 301 et seq.), to require changes in the
implementation of the custom device exemption under section 520(b) of
the FD&C Act (21 U.S.C. 360j(b)) (Ref. 1). Under the revised provision,
as under the original custom device exemption, a device that meets the
qualification of a custom device is exempt from 510(k) and Premarket
Approval (PMA) submissions under sections 514 and 515 of the FD&C Act
(21 U.S.C. 360d and 360e) (see also Sec. Sec. 807.85 and 812.3(b) (21
CFR 807.85 and 812.3(b)). Because of the amendments to section 520(b)
of the FD&C Act, the current regulatory definition for a custom device,
set forth in Sec. Sec. 807.85(a) and 812.3(b), is no longer consistent
with the statute. This technical amendment will correct the regulations
by revising the definition of a custom device to restate the statute.
Under existing regulations at Sec. 807.85(a), a custom device is
exempt from premarket notification under section 510(k) of the FD&C
Act. In the Federal Register of August 23, 1977 (42 FR 42520 at 42523),
FDA published a final rule establishing the form and manner for 510(k)
premarket notifications, which identified a custom device as an
exemption from the premarket approval requirement because a principal
purpose for requiring 510(k) premarket notification is absent. The
final rule explained that the exemption for manufacturers of custom
devices is intended to apply only to those who are manufacturing a
custom device to fit the needs of a particular patient, so the
manufacturer will not be required to file a premarket notification for
each particular device.
In the Federal Register of January 18, 1980 (45 FR 3732 at 3740),
FDA published a final rule setting forth the rules and conditions under
which investigations for medical devices involving human subjects may
be exempt from certain requirements of the FD&C Act. The 1980 final
rule provided clarification for the definition of ``custom devices''
under Sec. 812.3(b) for Investigational Device Exemptions (IDE) unless
used to determine safety and effectiveness for commercial distribution.
A device used to conduct a clinical trial cannot qualify as a custom
device.
Section 520(b) of the FD&C Act, as amended by section 617 of
FDASIA, changed some of the criteria to qualify for the custom device
exemption, which is different from the criteria currently described in
the regulations. The amendment to section 520(b) of the FD&C Act states
that a device will qualify as a ``custom device'' by meeting new
enumerated statutory requirements, including, among others, the
following for each device: (1) Is created or modified in order to
comply with the order of an individual physician or dentist (or other
specially qualified person); (2) necessarily deviates from an otherwise
applicable performance standard under section 514 or requirement under
section 515 of the FD&C Act; (3) is not generally available in the
United States in finished form through labeling or advertising by the
manufacturer, importer, or distributor for commercial distribution; (4)
is designed to treat a unique pathology or physiological condition that
no other device is domestically available to treat; (5) either (a) is
intended to meet the special needs of such physician or dentist in the
course of the professional practice of such physician or dentist (or
other specially qualified person as designated) in the course of their
professional practice or (b) is intended
[[Page 70340]]
for use by an individual patient named in the order of a physician or
dentist (or other specially qualified person as designated); (6) is
assembled from components or manufactured and finished on a case-by-
case basis to accommodate the unique needs of individuals, physician,
or dentist; and (7) may have common, standardized design
characteristics, chemical and material compositions, and manufacturing
processes as commercially distributed devices (21 U.S.C. 360j(b)).
The new provisions for the custom device exemption also include the
following limitations: (1) The device is for the purpose of treating a
``sufficiently rare condition, such that conducting clinical
investigations on such device would be impractical;'' (2) the
production of the device must be ``limited to no more than five units
per year of a particular device type''; and (3) a manufacturer is
required to submit an annual report to FDA on the custom devices it
supplied.
This technical amendment to the regulations for the custom device
exemption will ensure clarity and consistency with the requirements of
the FD&C Act. Some manufacturers might be unaware that certain medical
devices that they distribute as custom devices do not meet the
statutory definition as currently described in the regulations and are
subject to premarket review. Also, FDA issued the final guidance
entitled, ``Custom Device Exemption'' (Ref. 2) explaining the new
statutory provisions for custom devices. The guidance provides
definitions of certain terms used in connection with the custom device
exemption and explains how FDA interprets the devices that may qualify
for the custom device exemption under section 520(b) of the FD&C Act.
The guidance also describes in further detail what information should
be submitted in an annual report, and provides recommendations on how
to submit an annual report for custom devices distributed under the
exemption (Ref. 2). FDA finds good cause for issuing this amendment as
a final rule without notice and comment because this amendment only
corrects the implementing regulation to restate the statute (5 U.S.C.
553(b)(B)). ``[W]hen regulations merely restate the statute they
implement, notice-and-comment procedures are unnecessary.'' Gray
Panthers Advoc. Committee v. Sullivan, 936 F.2d 1284, 1291 (D.C. Cir.
1991). The amendments to Sec. Sec. 807.85(a) and 812.3(b) merely
incorporate applicable requirements of the FD&C Act, making notice-and-
comment procedures unnecessary in this case. Therefore, publication of
this document constitutes final action on this change under the
Administrative Procedure Act (APA) (5 U.S.C. 553).
In addition, FDA finds good cause for these amendments to become
effective on the date of publication of this action. The APA allows an
effective date less than 30 days after publication as ``provided by the
agency for good cause found and published with the rule'' (5 U.S.C.
553(d)(3)). A delayed effective date is unnecessary in this case
because the amendments to Sec. Sec. 807.85 and 812.3(b) do not impose
any new regulatory requirements on affected parties. As a result,
affected parties do not need time to prepare before the rule takes
effect. Therefore, FDA finds good cause for this correction to become
effective on the date of publication of this action.
II. References
The following references have been placed on display in the
Division of Dockets Management (located at 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852), and may be seen by interested persons between 9
a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site
address, but we are not responsible for any subsequent changes to the
Web site after this document publishes in the Federal Register.)
1. The Food and Drug Administration Safety and Innovation Act,
available at https://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm or at https://www.congress.gov/112/plaws/publ144/PLAW-112publ144.pdf.
2. Custom Device Exemption; Guidance for Industry and Food and Drug
Administration Staff; September 24, 2014, available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm415799.pdf.
List of Subjects
21 CFR Part 807
Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.
21 CFR Part 812
Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
parts 807 and 812 are amended as follows:
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INTITIAL IMPORTERS OF DEVICES
0
1. The authority citation for part 807 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.
0
2. Section 807.85 is amended by revising paragraph (a) introductory
text to read as follows:
Sec. 807.85 Exemption from premarket notification.
(a) A custom device is exempt from premarket notification
requirements of this subpart if the device is within the meaning of
section 520(b) of the Federal Food, Drug, and Cosmetic Act.
* * * * *
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
0
3. The authority citation for part 812 continues to read as follows:
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241,
262, 263b-263n.
0
4. Section 812.3 is amended by revising paragraph (b) to read as
follows:
Sec. 812.3 Definitions.
* * * * *
(b) A custom device means a device within the meaning of section
520(b) of the Federal Food, Drug, and Cosmetic Act.
* * * * *
Dated: October 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24438 Filed 10-11-16; 8:45 am]
BILLING CODE 4164-01-P
