81 FR 70339 - Medical Devices; Custom Devices; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 197 (October 12, 2016)

Page Range		70339-70340
FR Document		2016-24438

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.

Federal Register, Volume 81 Issue 197 (Wednesday, October 12, 2016)

[Federal Register Volume 81, Number 197 (Wednesday, October 12, 2016)]
[Rules and Regulations]
[Pages 70339-70340]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24438]


=======================================================================
-----------------------------------------------------------------------

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 http://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 http://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

Federal Register / Vol. 81, No. 197 / Wednesday, October 12, 2016 / Rules and Regulations 70339

in the List of Items Controlled section to DEPARTMENT OF HEALTH AND from premarket notification under
read as follows: HUMAN SERVICES section 510(k) of the FD&C Act. In the
7E994 ‘‘Technology,’’ n.e.s., for the
Federal Register of August 23, 1977 (42
Food and Drug Administration FR 42520 at 42523), FDA published a
‘‘development,’’ ‘‘production’’, or ‘‘use’’
of navigation, airborne communication,
final rule establishing the form and
21 CFR Parts 807 and 812 manner for 510(k) premarket
and other avionics equipment.
[Docket No. FDA–2016–N–2518] notifications, which identified a custom
* * * * * device as an exemption from the
List of Items Controlled Medical Devices; Custom Devices; premarket approval requirement
Technical Amendment because a principal purpose for
* * * * *
requiring 510(k) premarket notification
Related Controls: N/A AGENCY: Food and Drug Administration, is absent. The final rule explained that
* * * * * HHS. the exemption for manufacturers of
Final rule; technical
ACTION: custom devices is intended to apply
■ 46. In Supplement No. 1 to part 774, amendment. only to those who are manufacturing a
Category 8, ECCN 8A002 is amended by custom device to fit the needs of a
adding a sentence to the end of the SUMMARY: The Food and Drug
particular patient, so the manufacturer
Related Controls paragraph in the List of Administration (FDA or Agency) is
will not be required to file a premarket
amending its regulations on the
Items Controlled section to read as notification for each particular device.
definition of a custom device so as to
follows: In the Federal Register of January 18,
include new enumerated statutory
8A002 Marine systems, equipment, ‘‘parts’’
1980 (45 FR 3732 at 3740), FDA
requirements for custom devices under
and ‘‘components,’’ as follows (see List
published a final rule setting forth the
the Federal Food, Drug, and Cosmetic
of Items Controlled).
rules and conditions under which
Act (the FD&C Act) as amended by the
investigations for medical devices
* * * * * Food and Drug Administration Safety
involving human subjects may be
and Innovation Act (FDASIA). This new
List of Items Controlled exempt from certain requirements of the
provision, under FDASIA, amends the
FD&C Act. The 1980 final rule provided
* * * * * existing custom device exemption and
clarification for the definition of
Related Controls: * * * (5) Section 744.9 introduces new concepts and
‘‘custom devices’’ under § 812.3(b) for
imposes a license requirement on procedures applicable to custom
Investigational Device Exemptions (IDE)
commodities described in 8A002.d if being devices. This action is being taken to
unless used to determine safety and
exported, reexported, or transferred (in- align the regulations with the FD&C Act.
country) for use by a military end-user or
effectiveness for commercial
DATES: This rule is effective October 12, distribution. A device used to conduct
for incorporation into an item controlled 2016.
by ECCN 0A919.
a clinical trial cannot qualify as a
FOR FURTHER INFORMATION CONTACT: custom device.
* * * * * Erica B. Payne, Center for Devices and Section 520(b) of the FD&C Act, as
Radiological Health, Food and Drug amended by section 617 of FDASIA,
■ 47. In Supplement No. 1 to part 774, Administration, 10903 New Hampshire changed some of the criteria to qualify
Category 9, ECCN 9A991 is amended by: Ave., Bldg. 66, Rm. 5520, Silver Spring, for the custom device exemption, which
■ a. Removing the License Requirement MD 20993, 301–796–3999. is different from the criteria currently
Notes paragraph in the License SUPPLEMENTARY INFORMATION: described in the regulations. The
Requirements section, and amendment to section 520(b) of the
I. Background
FD&C Act states that a device will
■ b. Revising the Related Controls On July 9, 2012, section 617 of qualify as a ‘‘custom device’’ by meeting
paragraph in the List of Items Controlled FDASIA (Pub. L. 112–144), amended the new enumerated statutory requirements,
section. FD&C Act (21 U.S.C. 301 et seq.), to including, among others, the following
The revision reads as follows: require changes in the implementation for each device: (1) Is created or
of the custom device exemption under modified in order to comply with the
9A991 ‘‘Aircraft’’, n.e.s., and gas turbine
section 520(b) of the FD&C Act (21 order of an individual physician or
engines not controlled by 9A001 or
9A101 and ‘‘parts’’ and ‘‘components,’’
U.S.C. 360j(b)) (Ref. 1). Under the dentist (or other specially qualified
n.e.s. (see List of Items Controlled).
revised provision, as under the original person); (2) necessarily deviates from an
custom device exemption, a device that otherwise applicable performance
* * * * * meets the qualification of a custom standard under section 514 or
List of Items Controlled device is exempt from 510(k) and requirement under section 515 of the
Premarket Approval (PMA) submissions FD&C Act; (3) is not generally available
* * * * *
Related Controls: N/A
under sections 514 and 515 of the FD&C in the United States in finished form
Act (21 U.S.C. 360d and 360e) (see also through labeling or advertising by the
* * * * * §§ 807.85 and 812.3(b) (21 CFR 807.85 manufacturer, importer, or distributor
Dated: September 15, 2016. and 812.3(b)). Because of the for commercial distribution; (4) is
Kevin J. Wolf, amendments to section 520(b) of the designed to treat a unique pathology or
FD&C Act, the current regulatory physiological condition that no other
Assistant Secretary of Commerce for Export
Administration.
definition for a custom device, set forth device is domestically available to treat;
mstockstill on DSK3G9T082PROD with RULES

in §§ 807.85(a) and 812.3(b), is no longer (5) either (a) is intended to meet the
[FR Doc. 2016–24220 Filed 10–11–16; 8:45 am]
consistent with the statute. This special needs of such physician or
BILLING CODE 3510–33–P dentist in the course of the professional
technical amendment will correct the
regulations by revising the definition of practice of such physician or dentist (or
a custom device to restate the statute. other specially qualified person as
Under existing regulations at designated) in the course of their
§ 807.85(a), a custom device is exempt professional practice or (b) is intended

VerDate Sep<11>2014 16:05 Oct 11, 2016 Jkt 241001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\12OCR1.SGM 12OCR1

70340 Federal Register / Vol. 81, No. 197 / Wednesday, October 12, 2016 / Rules and Regulations

for use by an individual patient named unnecessary in this case. Therefore, PART 807—ESTABLISHMENT
in the order of a physician or dentist (or publication of this document constitutes REGISTRATION AND DEVICE LISTING
other specially qualified person as final action on this change under the FOR MANUFACTURERS AND INTITIAL
designated); (6) is assembled from Administrative Procedure Act (APA) (5 IMPORTERS OF DEVICES
components or manufactured and U.S.C. 553).
finished on a case-by-case basis to In addition, FDA finds good cause for ■ 1. The authority citation for part 807
accommodate the unique needs of these amendments to become effective continues to read as follows:
individuals, physician, or dentist; and on the date of publication of this action. Authority: 21 U.S.C. 321, 331, 351, 352,
(7) may have common, standardized The APA allows an effective date less 360, 360c, 360e, 360i, 360j, 371, 374, 381,
design characteristics, chemical and than 30 days after publication as 393; 42 U.S.C. 264, 271.
material compositions, and ‘‘provided by the agency for good cause ■ 2. Section 807.85 is amended by
manufacturing processes as found and published with the rule’’ (5 revising paragraph (a) introductory text
commercially distributed devices (21 U.S.C. 553(d)(3)). A delayed effective to read as follows:
U.S.C. 360j(b)). date is unnecessary in this case because
The new provisions for the custom the amendments to §§ 807.85 and § 807.85 Exemption from premarket
device exemption also include the 812.3(b) do not impose any new notification.
following limitations: (1) The device is regulatory requirements on affected (a) A custom device is exempt from
for the purpose of treating a parties. As a result, affected parties do premarket notification requirements of
‘‘sufficiently rare condition, such that not need time to prepare before the rule this subpart if the device is within the
conducting clinical investigations on takes effect. Therefore, FDA finds good meaning of section 520(b) of the Federal
such device would be impractical;’’ (2) cause for this correction to become Food, Drug, and Cosmetic Act.
the production of the device must be effective on the date of publication of
‘‘limited to no more than five units per * * * * *
this action.
year of a particular device type’’; and (3) PART 812—INVESTIGATIONAL
a manufacturer is required to submit an II. References
DEVICE EXEMPTIONS
annual report to FDA on the custom The following references have been
devices it supplied. placed on display in the Division of ■ 3. The authority citation for part 812
This technical amendment to the Dockets Management (located at 5630 continues to read as follows:
regulations for the custom device Fishers Lane, Rm. 1061, Rockville, MD
exemption will ensure clarity and Authority: 21 U.S.C. 331, 351, 352, 353,
20852), and may be seen by interested 355, 360, 360c-360f, 360h-360j, 371, 372, 374,
consistency with the requirements of persons between 9 a.m. and 4 p.m., 379e, 381, 382, 383; 42 U.S.C. 216, 241, 262,
the FD&C Act. Some manufacturers Monday through Friday. (FDA has 263b-263n.
might be unaware that certain medical verified the Web site address, but we are
devices that they distribute as custom ■ 4. Section 812.3 is amended by
not responsible for any subsequent
devices do not meet the statutory revising paragraph (b) to read as follows:
changes to the Web site after this
definition as currently described in the document publishes in the Federal § 812.3 Definitions.
regulations and are subject to premarket Register.)
review. Also, FDA issued the final * * * * *
1. The Food and Drug Administration (b) A custom device means a device
guidance entitled, ‘‘Custom Device Safety and Innovation Act, available at
Exemption’’ (Ref. 2) explaining the new within the meaning of section 520(b) of
http://www.fda.gov/ the Federal Food, Drug, and Cosmetic
statutory provisions for custom devices. RegulatoryInformation/Legislation/
The guidance provides definitions of Act.
SignificantAmendmentstotheFDCAct/
certain terms used in connection with * * * * *
FDASIA/ucm20027187.htm or at
the custom device exemption and https://www.congress.gov/112/plaws/ Dated: October 4, 2016.
explains how FDA interprets the publ144/PLAW-112publ144.pdf. Leslie Kux,
devices that may qualify for the custom 2. Custom Device Exemption; Associate Commissioner for Policy.
device exemption under section 520(b) Guidance for Industry and Food and [FR Doc. 2016–24438 Filed 10–11–16; 8:45 am]
of the FD&C Act. The guidance also Drug Administration Staff; September BILLING CODE 4164–01–P
describes in further detail what 24, 2014, available at http://
information should be submitted in an www.fda.gov/ucm/groups/fdagov-
annual report, and provides public/@fdagov-meddev-gen/
recommendations on how to submit an DEPARTMENT OF STATE
documents/document/ucm415799.pdf.
annual report for custom devices
distributed under the exemption (Ref. List of Subjects 22 CFR Part 121
2). FDA finds good cause for issuing this [Public Notice: 9605]
21 CFR Part 807
amendment as a final rule without
Confidential business information, RIN 1400–AD32
notice and comment because this
amendment only corrects the Imports, Medical devices, Reporting and
Amendment to the International Traffic
implementing regulation to restate the recordkeeping requirements.
in Arms Regulations: Revision of U.S.
statute (5 U.S.C. 553(b)(B)). ‘‘[W]hen 21 CFR Part 812 Munitions List Category XII
regulations merely restate the statute
they implement, notice-and-comment Health records, Medical devices, AGENCY: Department of State.
mstockstill on DSK3G9T082PROD with RULES

procedures are unnecessary.’’ Gray Medical research, Reporting and
ACTION: Final rule.
Panthers Advoc. Committee v. Sullivan, recordkeeping requirements.
936 F.2d 1284, 1291 (D.C. Cir. 1991). Therefore, under the Federal Food, SUMMARY: As part of the President’s
The amendments to §§ 807.85(a) and Drug, and Cosmetic Act and under the Export Control Reform effort, the
812.3(b) merely incorporate applicable authority delegated to the Commissioner Department of State amends the
requirements of the FD&C Act, making of Food and Drugs, 21 CFR parts 807 International Traffic in Arms
notice-and-comment procedures and 812 are amended as follows: Regulations (ITAR) by revising Category

VerDate Sep<11>2014 16:05 Oct 11, 2016 Jkt 241001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\FR\FM\12OCR1.SGM 12OCR1

Document Created: 2016-10-12 00:55:13
Document Modified: 2016-10-12 00:55:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; technical amendment.
Dates		This rule is effective October 12, 2016.
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.
FR Citation		81 FR 70339
CFR Citation		21 CFR 807 21 CFR 812
CFR Associated		Confidential Business Information; Imports; Medical Devices; Reporting and Recordkeeping Requirements; Health Records and Medical Research

81 FR 70339 - Medical Devices; Custom Devices; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 197 (October 12, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration