Source: https://www.federalregister.gov/documents/2017/03/01/2017-03997/gastroenterology-urology-devices-manual-gastroenterology-urology-surgical-instruments-and
Timestamp: 2019-09-15 22:20:11
Document Index: 610384219

Matched Legal Cases: ['§\u2009876', '§\u2009876', '§\u2009876', '§\u2009876', '§\u2009876', '§\u2009876', '§\u2009876', '§\u2009876', '§\u2009884']

Federal Register :: Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories
This rule is effective March 1, 2017.
Docket No. FDA-2016-N-4661
FDA-2016-N-4661
https://www.federalregister.gov/d/2017-03997 https://www.federalregister.gov/d/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.
FDA is amending § 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 § 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 § 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 § 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 § 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 § 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.
2. Amend § 876.4730 by revising paragraph (a) to read as follows:
§ 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 § 884.4910 of this chapter.
[FR Doc. 2017-03997 Filed 2-28-17; 8:45 am]