82 FR 12171 - Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 39 (March 1, 2017)

Page Range		12171-12171
FR Document		2017-03997

The Food and Drug Administration (FDA) is amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures (``specialized surgical instrumentation for use with urogynecologic surgical mesh''). These amendments are being made to reflect changes made in the recently issued final reclassification order for specialized surgical instrumentation for use with urogynecologic surgical mesh.

Federal Register, Volume 82 Issue 39 (Wednesday, March 1, 2017)

[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Rules and Regulations]
[Page 12171]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03997]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2016-N-4661]


Gastroenterology-Urology Devices; Manual Gastroenterology-Urology 
Surgical Instruments and Accessories

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
identification of manual gastroenterology-urology surgical instruments 
and accessories to reflect that the device does not include specialized 
surgical instrumentation for use with urogyencologic surgical mesh 
specifically intended for use as an aid in the insertion, placement, 
fixation, or anchoring of surgical mesh during urogynecologic 
procedures (``specialized surgical instrumentation for use with 
urogynecologic surgical mesh''). These amendments are being made to 
reflect changes made in the recently issued final reclassification 
order for specialized surgical instrumentation for use with 
urogynecologic surgical mesh.

DATES: This rule is effective March 1, 2017.

FOR FURTHER INFORMATION CONTACT: Sharon Andrews, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. G110, 
Silver Spring, MD 20993, 301-796-6529, Sharon.Andrews@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is amending Sec.  876.4730 (21 CFR 
876.4730, Manual gastroenterology-urology surgical instrument and 
accessories), by adding language to the identification of the device to 
reflect that specialized surgical instrumentation for use with 
urogynecologic surgical mesh is no longer regulated under Sec.  
876.4730.
    In the Federal Register of November 23, 1983 (48 FR 53012), FDA 
issued a final rule classifying manual gastroenterology-urology 
surgical instrument and accessories into class I under Sec.  876.4730 
(48 FR 53012 at 53025). Certain specialized surgical instrumentation 
for use with urogynecologic surgical mesh was regulated as class I 
devices under that regulation. In the Federal Register of January 6, 
2017 (82 FR 1598), FDA issued a final order reclassifying specialized 
surgical instrumentation for use with urogynecologic surgical mesh from 
class I (general controls) exempt from premarket notification to class 
II (special controls) and subject to premarket notification. As a 
result of that final reclassification order, FDA is amending the 
identification at Sec.  876.4730(a) to reflect that specialized 
surgical instrumentation for use with urogynecologic surgical mesh is 
now regulated under 21 CFR 884.4910.
    FDA finds good cause for issuing this amendment as a final rule 
without notice and comment because this rule only updates the 
identification of the device under Sec.  876.4730 to reflect changes 
made in the recently issued final reclassification order for 
specialized surgical instrumentation for use with urogynecologic 
surgical mesh (5 U.S.C. 553(b)(B)). In addition, FDA finds good cause 
for this amendment to become effective on the date of publication of 
this action. The Administrative Procedure Act 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 
amendment to Sec.  876.4730 does 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 amendment to become effective on the date of 
publication of this action.

List of Subjects in 21 CFR Part 876

    Gastroenterology-urology devices, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Amend Sec.  876.4730 by revising paragraph (a) to read as follows:


Sec.  876.4730   Manual gastroenterology-urology surgical instrument 
and accessories.

    (a) Identification. A manual gastroenterology-urology surgical 
instrument and accessories is a device designed to be used for 
gastroenterological and urological surgical procedures. The device may 
be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-
urology surgical instruments include the biopsy forceps cover, biopsy 
tray without biopsy instruments, line clamp, nonpowered rectal probe, 
nonelectrical clamp, colostomy spur-crushers, locking device for 
intestinal clamp, needle holder, gastro-urology hook, gastro-urology 
probe and director, nonself-retaining retractor, laparotomy rings, 
nonelectrical snare, rectal specula, bladder neck spreader, self-
retaining retractor, and scoop. A manual surgical instrument that is 
intended specifically for use as an aid in the insertion, placement, 
fixation, or anchoring of surgical mesh during urogynecologic 
procedures are classified under Sec.  884.4910 of this chapter.
* * * * *

    Dated: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03997 Filed 2-28-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules and Regulations 12171

Therefore, under authority delegated SUPPLEMENTARY INFORMATION: FDA is of Food and Drugs, 21 CFR part 876 is
to the Commissioner of Food and Drugs amending § 876.4730 (21 CFR 876.4730, amended as follows:
and redelegated to the Center for Manual gastroenterology-urology
Veterinary Medicine, and in accordance surgical instrument and accessories), by PART 876—GASTROENTEROLOGY-
with § 514.116 Notice of withdrawal of adding language to the identification of UROLOGY DEVICES
approval of application (21 CFR the device to reflect that specialized
514.116), notice is given that approval surgical instrumentation for use with ■ 1. The authority citation for part 876
of NADA 135–773 and ANADA 200– urogynecologic surgical mesh is no continues to read as follows:
421, and all supplements and longer regulated under § 876.4730. Authority: 21 U.S.C. 351, 360, 360c, 360e,
amendments thereto, is hereby In the Federal Register of November 360j, 360l, 371.
withdrawn, effective March 13, 2017. 23, 1983 (48 FR 53012), FDA issued a ■ 2. Amend § 876.4730 by revising
Elsewhere in this issue of the Federal final rule classifying manual paragraph (a) to read as follows:
Register, FDA is amending the animal gastroenterology-urology surgical
drug regulations to reflect the voluntary instrument and accessories into class I § 876.4730 Manual gastroenterology-
withdrawal of approval of these under § 876.4730 (48 FR 53012 at urology surgical instrument and
applications. 53025). Certain specialized surgical accessories.
instrumentation for use with (a) Identification. A manual
Dated: February 23, 2017.
urogynecologic surgical mesh was gastroenterology-urology surgical
Leslie Kux,
regulated as class I devices under that instrument and accessories is a device
Associate Commissioner for Policy. regulation. In the Federal Register of designed to be used for
[FR Doc. 2017–03931 Filed 2–28–17; 8:45 am] January 6, 2017 (82 FR 1598), FDA gastroenterological and urological
BILLING CODE 4164–01–P issued a final order reclassifying surgical procedures. The device may be
specialized surgical instrumentation for nonpowered, hand-held, or hand-
use with urogynecologic surgical mesh manipulated. Manual gastroenterology-
DEPARTMENT OF HEALTH AND from class I (general controls) exempt urology surgical instruments include the
HUMAN SERVICES from premarket notification to class II biopsy forceps cover, biopsy tray
(special controls) and subject to without biopsy instruments, line clamp,
Food and Drug Administration premarket notification. As a result of nonpowered rectal probe, nonelectrical
that final reclassification order, FDA is clamp, colostomy spur-crushers, locking
21 CFR Part 876 amending the identification at device for intestinal clamp, needle
[Docket No. FDA–2016–N–4661] § 876.4730(a) to reflect that specialized holder, gastro-urology hook, gastro-
surgical instrumentation for use with urology probe and director, nonself-
Gastroenterology-Urology Devices; urogynecologic surgical mesh is now retaining retractor, laparotomy rings,
Manual Gastroenterology-Urology regulated under 21 CFR 884.4910. nonelectrical snare, rectal specula,
Surgical Instruments and Accessories FDA finds good cause for issuing this bladder neck spreader, self-retaining
amendment as a final rule without retractor, and scoop. A manual surgical
AGENCY: Food and Drug Administration,
notice and comment because this rule instrument that is intended specifically
HHS.
only updates the identification of the for use as an aid in the insertion,
Final rule; technical
ACTION: device under § 876.4730 to reflect
amendment. placement, fixation, or anchoring of
changes made in the recently issued surgical mesh during urogynecologic
SUMMARY: The Food and Drug final reclassification order for procedures are classified under
Administration (FDA) is amending the specialized surgical instrumentation for § 884.4910 of this chapter.
identification of manual use with urogynecologic surgical mesh
* * * * *
gastroenterology-urology surgical (5 U.S.C. 553(b)(B)). In addition, FDA
finds good cause for this amendment to Dated: February 23, 2017.
instruments and accessories to reflect
become effective on the date of Leslie Kux,
that the device does not include
specialized surgical instrumentation for publication of this action. The Associate Commissioner for Policy.
use with urogyencologic surgical mesh Administrative Procedure Act allows an [FR Doc. 2017–03997 Filed 2–28–17; 8:45 am]
specifically intended for use as an aid effective date less than 30 days after BILLING CODE 4164–01–P
in the insertion, placement, fixation, or publication as ‘‘provided by the agency
anchoring of surgical mesh during for good cause found and published
urogynecologic procedures with the rule’’ (5 U.S.C. 553(d)(3)). A DEPARTMENT OF JUSTICE
(‘‘specialized surgical instrumentation delayed effective date is unnecessary in
for use with urogynecologic surgical this case because the amendment to Drug Enforcement Administration
mesh’’). These amendments are being § 876.4730 does not impose any new
made to reflect changes made in the regulatory requirements on affected 21 CFR Part 1308
parties. As a result, affected parties do
recently issued final reclassification [Docket No. DEA–436]
not need time to prepare before the rule
order for specialized surgical
takes effect. Therefore, FDA finds good
instrumentation for use with Schedules of Controlled Substances:
cause for this amendment to become
urogynecologic surgical mesh. Placement of 10 Synthetic Cathinones
effective on the date of publication of
DATES: This rule is effective March 1, Into Schedule I
this action.
jstallworth on DSK7TPTVN1PROD with RULES

2017. AGENCY: Drug Enforcement
FOR FURTHER INFORMATION CONTACT:
List of Subjects in 21 CFR Part 876
Administration, Department of Justice.
Sharon Andrews, Center for Devices and Gastroenterology-urology devices, ACTION: Final rule.
Radiological Health, 10903 New Medical devices.
Hampshire Ave., Bldg. 66, Rm. G110, Therefore, under the Federal Food, SUMMARY: With the issuance of this final
Silver Spring, MD 20993, 301–796– Drug, and Cosmetic Act and under rule, the Drug Enforcement
6529, Sharon.Andrews@fda.hhs.gov. authority delegated to the Commissioner Administration places 10 synthetic

VerDate Sep<11>2014 14:27 Feb 28, 2017 Jkt 241001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\01MRR1.SGM 01MRR1

Document Created: 2017-03-01 03:39:24
Document Modified: 2017-03-01 03:39:24

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 March 1, 2017.
Contact		Sharon Andrews, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. G110, Silver Spring, MD 20993, 301-796-6529, [email protected]
FR Citation		82 FR 12171
CFR Associated		Gastroenterology-Urology Devices and Medical Devices

82 FR 12171 - Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 39 (March 1, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration