Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems, 2217 [C1-2016-31670]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations
promulgated regulations exempting the
drug from the requirements of section
502(f)(1), to provide for such drug
adequate labeling that accords with
such other intended uses.
List of Subjects
21 CFR Part 201
Drugs, Labeling, Reporting and
recordkeeping requirements.
21 CFR Part 801
Labeling, Medical devices, Reporting
and recordkeeping requirements.
21 CFR Part 1100
Combination products, Devices,
Drugs, Smoking, Tobacco.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR chapter 1 is
amended as follows:
PART 201—LABELING
1. The authority citation for part 201
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 358, 360, 360b, 360gg–360ss, 371,
374, 379e; 42 U.S.C. 216, 241, 262, 264.
■
2. Revise § 201.128 to read as follows:
sradovich on DSK3GMQ082PROD with RULES
§ 201.128
Meaning of ‘‘intended uses’’.
The words intended uses or words of
similar import in §§ 201.5, 201.115,
201.117, 201.119, 201.120, 201.122, and
1100.5 of this chapter refer to the
objective intent of the persons legally
responsible for the labeling of drugs.
The intent is determined by such
persons’ expressions or may be shown
by the circumstances surrounding the
distribution of the article. This objective
intent may, for example, be shown by
labeling claims, advertising matter, or
oral or written statements by such
persons or their representatives. It may
be shown, for example, by
circumstances in which the article is,
with the knowledge of such persons or
their representatives, offered and used
for a purpose for which it is neither
labeled nor advertised. The intended
uses of an article may change after it has
been introduced into interstate
commerce by its manufacturer. If, for
example, a packer, distributor, or seller
intends an article for different uses than
those intended by the person from
whom he received the drug, such
packer, distributor, or seller is required
to supply adequate labeling in
accordance with the new intended uses.
And if the totality of the evidence
establishes that a manufacturer
objectively intends that a drug
introduced into interstate commerce by
him is to be used for conditions,
purposes, or uses other than ones for
which it is approved (if any), he is
required, in accordance with section
502(f) of the Federal Food, Drug, and
Cosmetic Act, or, as applicable, duly
VerDate Sep<11>2014
16:50 Jan 06, 2017
Jkt 241001
2217
Authority: 21 U.S.C. 387a(b), 387f(d);
Secs. 901(b) and 906(d), Pub. L. 111–31; 21
CFR 16.1 and 1107.1; 21 CFR 1.1, 1.20, 14.55,
17.1, and 17.2. Section 1100.5 is issued
under 21 U.S.C. 321, 353(g), and 371(a); 21
CFR 1.1.
PART 801—LABELING
■
■
3. The authority citation for part 801
continues to read as follows:
§ 1100.5 Exclusion from tobacco
regulation.
Authority: 21 U.S.C. 321, 331, 351, 352,
360d, 360i, 360j, 371, 374.
If a product made or derived from
tobacco that is intended for human
consumption is intended for use for any
of the purposes described in paragraph
(a) or (b) of this section, the product is
not a tobacco product as defined in
section 201(rr) of the Federal Food,
Drug, and Cosmetic Act and will be
subject to regulation as a drug, device,
or combination product.
(a) The product is intended for use in
the diagnosis of disease or other
conditions, or in the cure, mitigation,
treatment or prevention of disease,
including use in the cure or treatment
of nicotine addiction (e.g., smoking
cessation), relapse prevention, or relief
of nicotine withdrawal symptoms;
(b) The product is intended to affect
the structure or any function of the body
in any way that is different from effects
related to nicotine that were commonly
and legally claimed in the marketing of
cigarettes and smokeless tobacco
products prior to March 21, 2000.
■
6. Part 1100 is amended by adding
§ 1100.5 to read as follows:
4. Revise § 801.4 to read as follows:
§ 801.4
Meaning of intended uses.
The words intended uses or words of
similar import in §§ 801.5, 801.119,
801.122, and 1100.5 of this chapter refer
to the objective intent of the persons
legally responsible for the labeling of
devices. The intent is determined by
such persons’ expressions or may be
shown by the circumstances
surrounding the distribution of the
article. This objective intent may, for
example, be shown by labeling claims,
advertising matter, or oral or written
statements by such persons or their
representatives. It may be shown, for
example, by circumstances in which the
article is, with the knowledge of such
persons or their representatives, offered
and used for a purpose for which it is
neither labeled nor advertised. The
intended uses of an article may change
after it has been introduced into
interstate commerce by its
manufacturer. If, for example, a packer,
distributor, or seller intends an article
for different uses than those intended by
the person from whom he received the
device, such packer, distributor, or
seller is required to supply adequate
labeling in accordance with the new
intended uses. And if the totality of the
evidence establishes that a manufacturer
objectively intends that a device
introduced into interstate commerce by
him is to be used for conditions,
purposes, or uses other than ones for
which it has been approved, cleared,
granted marketing authorization, or is
exempt from premarket notification
requirements (if any), he is required, in
accordance with section 502(f) of the
Federal Food, Drug, and Cosmetic Act,
or, as applicable, duly promulgated
regulations exempting the device from
the requirements of section 502(f)(1), to
provide for such device adequate
labeling that accords with such other
intended uses.
PART 1100—TOBACCO PRODUCTS
SUBJECT TO FDA AUTHORITY
5. The authority citation for part 1100
is revised to read as follows:
■
PO 00000
Frm 00025
Fmt 4700
Sfmt 9990
Dated: December 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31950 Filed 1–6–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA–2014–N–1205]
Orthopedic Devices; Reclassification
of Pedicle Screw Systems, Henceforth
To Be Known as Thoracolumbosacral
Pedicle Screw Systems, Including
Semi-Rigid Systems
Correction
In rule document 2016–31670
beginning on page 96366 in the issue of
Friday, December 30, 2016, make the
following correction:
On page 96372, in the second column,
in the 25th, 51st, and 67th lines, and in
the third column, in the tenth line,
‘‘June 28, 2018’’ should read ‘‘July 1,
2019’’.
[FR Doc. C1–2016–31670 Filed 1–6–17; 8:45 am]
BILLING CODE 1301–00–D
E:\FR\FM\09JAR1.SGM
09JAR1
]]>Agencies
[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Rules and Regulations]
[Page 2217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: C1-2016-31670]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2014-N-1205]
Orthopedic Devices; Reclassification of Pedicle Screw Systems,
Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems,
Including Semi-Rigid Systems
Correction
In rule document 2016-31670 beginning on page 96366 in the issue of
Friday, December 30, 2016, make the following correction:
On page 96372, in the second column, in the 25th, 51st, and 67th
lines, and in the third column, in the tenth line, ``June 28, 2018''
should read ``July 1, 2019''.
[FR Doc. C1-2016-31670 Filed 1-6-17; 8:45 am]
BILLING CODE 1301-00-D
