[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.

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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