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)

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, 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, [email protected].

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]
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