82 FR 1598 - Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 4 (January 6, 2017)

The Food and Drug Administration (FDA or the Agency) is reclassifying 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, and identifying them as ``specialized surgical instrumentation for use with urogynecologic surgical mesh.'' FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.

[Federal Register Volume 82, Number 4 (Friday, January 6, 2017)]
[Rules and Regulations]
[Pages 1598-1603]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31862]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2014-N-0297]


Obstetrical and Gynecological Devices; Reclassification of 
Surgical Instrumentation for Use With Urogynecologic Surgical Mesh

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reclassifying 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, and identifying them as ``specialized surgical 
instrumentation for use with urogynecologic surgical mesh.'' FDA is 
designating special controls that are necessary to provide a reasonable 
assurance of safety and effectiveness of the device. FDA is 
reclassifying this device on its own initiative based on new 
information.

DATES: This order is effective January 6, 2017. See further discussion 
in section V, ``Implementation Strategy.''

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:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
301 et seq.), as amended, established a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of 
devices, reflecting the regulatory controls needed to provide 
reasonable assurance of their safety and effectiveness. The three 
categories of devices are class I (general controls), class II (special 
controls), and class III (premarket approval).
    Devices that were in commercial distribution before the enactment 
of the 1976 amendments on May 28, 1976, are generally referred to as 
preamendments devices. Under section 513(d) of the FD&C Act, 
preamendments devices are classified after FDA has: (1) Received a 
recommendation from a device classification panel (an FDA advisory 
committee); (2) published the panel's recommendation for comment, along 
with a proposed regulation classifying the device; and (3) published a 
final regulation classifying the device. FDA has classified most 
preamendments devices under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, are generally referred to as postamendments devices. 
Postamendments devices are automatically classified into class III 
without any FDA rulemaking process (section 513(f) of the FD&C Act). 
Postamendments devices remain in class III and require premarket 
approval unless, and until, the device is reclassified into class I or 
II or FDA issues an order finding the device to be substantially 
equivalent, under section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and 21 CFR part 807.
    On July 9, 2012, the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Pub. L. 112-144) was enacted. Section 608(a) 
of FDASIA amended section 513(e) of the FD&C Act, changing the 
mechanism for reclassifying a device from rulemaking to an 
administrative order.
    Section 513(e) of the FD&C Act provides that FDA may, by 
administrative order, reclassify a device based upon ``new 
information.'' FDA can initiate a reclassification under section 513(e) 
of the FD&C Act or an interested person may petition FDA to reclassify 
a device. The term ``new information,'' as used in section 513(e) of 
the FD&C Act, includes information developed as a result of a 
reevaluation of the data before the Agency when the device was 
originally classified, as well as information not presented, not 
available, or not developed at that time. (See, e.g., Holland-Rantos 
Co. v. United States Department of Health, Education, and Welfare, 587 
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent action where the reevaluation is made 
in light of newly available authority (see Bell, 366 F.2d at 181; 
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in 
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951). 
Whether data before the Agency are old or new data, the ``new 
information'' to support reclassification under section 513(e) must be 
``valid scientific evidence,'' as defined in section 513(a)(3) of the 
FD&C Act and Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., Gen. 
Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. 
Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 
1062 (1986).) To be considered in the reclassification process, the 
``valid scientific evidence'' upon which the Agency relies must be 
publicly available. Publicly available information excludes trade 
secret and/or confidential commercial information, e.g., the contents 
of a pending premarket approval application (PMA). (See section 520(c) 
of the FD&C Act (21 U.S.C. 360j(c)).)
    The process for issuing a final reclassification order is specified 
in section 513(e)(1) of the FD&C Act. Prior to the issuance of a final 
order reclassifying a device, the following must occur: (1) Publication 
of a proposed order in the Federal Register;

[[Page 1599]]

(2) a meeting of a device classification panel described in section 
513(b) of the FD&C Act; and (3) consideration of comments to a public 
docket.
    In the Federal Register of May 1, 2014, FDA published a proposed 
order to reclassify surgical mesh for transvaginal pelvic organ 
prolapse (POP) repair from class II to class III (79 FR 24634). In the 
same order, FDA also proposed to reclassify specialized surgical 
instrumentation for use with urogynecologic surgical mesh (hereafter 
referred to as urogynecologic surgical mesh instrumentation) from class 
I--regulated under Sec.  876.4730 (21 CFR 876.4730) (manual 
gastroenterology-urology surgical instrument and accessories) and Sec.  
878.4800 (21 CFR 878.4800) (manual surgical instrument for general 
use)--to class II and subject to premarket notification. In the Federal 
Register of January 5, 2016, FDA published two final orders that: (1) 
Reclassified surgical mesh for transvaginal POP repair from class II to 
class III (81 FR 354) and (2) required the filing of a PMA or notice of 
completion of a product development protocol for surgical mesh for 
transvaginal POP repair (81 FR 364).
    In the May 1, 2014 proposed order, FDA stated that it would convene 
a panel specifically to discuss reclassification of urogynecologic 
surgical mesh instrumentation before finalizing reclassification of 
those devices. FDA held a meeting on February 26, 2016 (81 FR 938, 
January 8, 2016), of the Gastroenterology-Urology Devices Panel of the 
Medical Devices Advisory Committee (``the Panel''), a device 
classification panel described in section 513(b) of the FD&C Act. Prior 
to the meeting, all panel members were provided a comprehensive 
Executive Summary regarding the reclassification of urogynecologic 
surgical mesh instrumentation, which included information contained in 
the May 1, 2014, proposed order, a summary of comments submitted to the 
public docket on the proposed reclassification of urogynecologic 
surgical mesh instrumentation, and information regarding FDA's risk-
based classification and regulation of medical devices (Ref. 1).
    The Executive Summary also included a new FDA analysis of 
perioperative adverse events related to urogynecologic surgical mesh 
procedures. FDA conducted a new analysis to supplement the adverse 
event information discussed in the May 1, 2014, proposed order, which 
included adverse events related to POP procedures that were: (1) 
Reported in clinical studies and systematic literature reviews in the 
published literature or (2) submitted to the Manufacturer and User 
Facility Device Experience (MAUDE) database between January 1, 2011, 
and December 31, 2013. FDA's new analysis was a more comprehensive 
analysis of perioperative adverse events associated with stress urinary 
incontinence (SUI) procedures (retropubic, transobturator, mini-sling) 
and POP procedures (transvaginal repair and transabdominal repair 
(transabdominal POP repair is referred to as sacrocolpopexy)).
    Adverse events related to a urogynecologic surgical mesh procedure, 
and that might be attributable to the specialized instrumentation used 
during the procedure, are typically submitted to FDA or described in 
published literature with reference to the surgical mesh and not the 
instrumentation. Therefore, it can be difficult to distinguish adverse 
events related to the urogynecologic surgical mesh instrumentation from 
those related to the surgical mesh. As noted in the proposed order, FDA 
believes it is reasonable to assume that perioperative adverse events--
i.e., those observed during the procedure or shortly thereafter (e.g., 
organ perforation, hemorrhage and bleeding, nerve injury and pain)--are 
caused by or related to the use of specialized surgical instrumentation 
to insert, place, fix, or anchor the surgical mesh during the 
urogynecologic procedure. Hereafter, the term ``perioperative adverse 
events'' will be used in this document to refer to adverse events that 
FDA believes are caused by or related to the specialized 
instrumentation that is the subject of this reclassification.
    In its new, more comprehensive analysis, FDA conducted a search of 
the relevant, scientific literature published between January 1, 1997, 
and December 8, 2015, to identify perioperative adverse events 
associated with urogynecologic surgical mesh procedures (see the 207 
studies included as references in the Executive Summary provided to the 
Panel (Ref. 1). The search criteria consisted of a combination of terms 
related to adverse events (type, timing with respect to surgery), type 
of urogynecologic condition, type of surgical instrumentation, study 
design, device name, and manufacturer name. FDA then filtered the 
results to identify those studies that describe perioperative adverse 
events during one of the following urogynecologic surgical mesh 
procedures: SUI-retropubic, SUI-transobturator, SUI-mini-sling, POP-
transvaginal, and POP-sacrocolpopexy. All perioperative adverse events 
were classified into one of the following categories: ``organ 
perforation and injury,'' ``vascular injury and bleeding,'' or ``nerve 
injury and pain.'' FDA then computed an adverse event rate for each 
study by dividing the number of patients that experienced one of these 
types of events by the total number of patients included in the study.
    FDA also conducted a search of the Medical Device Reporting (MDR) 
database for relevant adverse events reported between January 1, 2008, 
and December 2, 2015. There are no FDA product codes specifically 
assigned to urogynecologic surgical mesh instrumentation; therefore, 
FDA first identified reports that were associated with a product code 
assigned to urogynecologic surgical mesh. FDA filtered the resulting 
injury and death reports to identify and analyze those that described 
perioperative adverse events. By stratifying its analysis by product 
code for the urogynecologic surgical mesh, which depends, in part, on 
the procedure type (e.g., OTP is assigned to mesh used during POP-
transvaginal procedures, OTN for mesh used during SUI-retropubic or 
transobturator procedures), FDA characterized the perioperative adverse 
events associated with the different kinds of urogynecologic surgical 
mesh instrumentation used during SUI and POP procedures.
    After completing its review of the published literature and MDR 
database, and aggregating its findings, FDA determined that 
perioperative adverse events occur during all types of urogynecologic 
surgical mesh procedures to treat female SUI and POP. Moreover, and as 
discussed in the Executive Summary (Ref. 1, Attachments 6-8), FDA made 
the following findings from its review of the published literature:
     The rate of ``vascular injury and bleeding'' varied 
between 0.4-29.4 percent in studies describing retropubic SUI 
procedures; 0.2-11.9 percent in studies describing transobturator SUI 
procedures; 1-20.5 percent in studies describing mini-sling SUI 
procedures; 0.7-7.7 percent in studies describing transvaginal POP 
repair procedures; and 2.8 percent for one study describing 
sacrocolpoplexy procedures;
     the rate of ``organ perforation and injury'' varied 
between 0.3-23.8 percent for retropubic SUI procedures; 0.2-5.8 percent 
for transobturator SUI procedures, 0.2-2.6 percent for mini-sling SUI 
procedures; 0.7-13.1 percent for transvaginal POP repair procedures; 
and 3.6 percent for one study describing sacrocolpoplexy procedures; 
and

[[Page 1600]]

     the rate of ``nerve injury and pain'' varied between 0.1-
5.3 percent for retropubic SUI procedures; 0.8-30.8 percent for 
transobturator SUI procedures, 1.1-4.1 percent for mini-sling SUI 
procedures; 6.0-39.1 percent for transvaginal POP repair procedures; 
and 14.9 percent for one study describing sacrocolpoplexy procedures.
    FDA presented a summary of the information contained in the 
Executive Summary during the February 26, 2016, panel meeting (Ref. 2). 
The Panel then discussed whether urogynecologic surgical mesh 
instrumentation should be reclassified, and if so, whether it should be 
reclassified from class I (general controls) to class II (special 
controls) or class III (premarket approval) (Ref. 3). The Panel 
discussed a variety of potential causes for the perioperative adverse 
events identified by FDA (e.g., instrumentation design, surgeon error, 
and surgeon experience). The Panel consensus was that the risks to 
health of urogynecologic surgical mesh instrumentation that FDA 
identified in the proposed order and Executive Summary (i.e., 
perioperative risks; damage to blood vessels, nerves, connective 
tissue, and other structures; adverse tissue reaction; and infection) 
was a complete and accurate list.
    The Panel agreed with FDA that the device is not purported or 
represented for a use in supporting or sustaining human life, or for a 
use which is of substantial importance in preventing impairment of 
human health, or presents a potential unreasonable risk of illness or 
injury. In light of this assessment, the Panel consensus was that 
urogynecologic surgical mesh instrumentation did not meet the 
definition of a class III device. The Panel also agreed with FDA that 
general controls alone are not sufficient to provide reasonable 
assurance of safety and effectiveness for the device, and that there is 
sufficient information to establish special controls to provide such 
assurance. When considering the specific special controls proposed by 
FDA, two Panel members requested that an additional special control be 
the submission of clinical data. However, after additional discussion, 
the Panel unanimously agreed that the special controls proposed by FDA, 
which did not include the submission of clinical data, would 
appropriately mitigate the risks to health of this device. As such, the 
Panel recommended that urogynecologic surgical mesh instrumentation be 
reclassified from class I (general controls) exempt from premarket 
notification to class II (special controls).

II. Key Changes From Proposed Order

    In the final order, FDA is modifying two of the special controls 
included in the proposed order. First, FDA is revising Sec.  
884.4910(b)(2) (21 CFR 884.4910(b)(2)) to require a demonstration that 
the device, if reusable, can be adequately reprocessed. Reprocessing 
validation will help to ensure that reusable urogynecologic surgical 
mesh instrumentation is fit for subsequent use after being previously 
used or contaminated. The validated processes are designed to remove 
soil and contaminants by cleaning and to inactivate microorganisms by 
disinfection or sterilization. Although FDA recognized in the proposed 
order that ``the risk of infection due to inadequate sterilization and/
or reprocessing instructions/procedures can be mitigated through 
sterilization validation testing and the inclusion of validated 
reprocessing instructions in the device labeling,'' proposed Sec.  
884.4910(b)(2) addressed sterilization only. FDA believes this revised 
special control will help to mitigate the risks posed by infection from 
reusable urogynecologic surgical mesh instrumentation.
    Second, FDA is revising Sec.  884.4910(b)(4) to require that non-
clinical performance testing demonstrate that the device: (1) Meets all 
design specifications and performance requirements and (2) performs as 
intended under anticipated conditions of use. In the proposed order, 
FDA specified that ``[b]ench and/or cadaver testing must demonstrate 
safety and effectiveness in expected-use conditions.'' FDA has revised 
the reference to ``bench and/or cadaver testing'' to ``non-clinical 
performance testing'' to allow for additional types of non-clinical 
testing that will also mitigate the corresponding risks to health. FDA 
is making other revisions to this provision as noted previously to 
provide further clarity.

III. Public Comments in Response to the Proposed Order

    FDA received comments regarding the proposed reclassification of 
urogynecologic surgical mesh instrumentation from class I to class II. 
A summary of the comments and FDA's responses are provided in this 
section. Certain comments are grouped together under a single number 
because the subject matter is similar. The number assigned to each one 
is purely for organizational purposes and does not signify the 
comment's value, importance, or the order in which it was received.
    (Comment 1) Several comments supported reclassification of 
urogynecologic surgical mesh instrumentation, with some comments 
supporting reclassification into class II and others supporting 
reclassification into class III.
    (Response 1) FDA agrees with comments supporting reclassification 
of urogynecologic surgical mesh instrumentation into class II and 
disagrees with comments that support reclassification into class III. 
Based on information set forth in the proposed order (79 FR 24634), FDA 
tentatively concluded in that order that certain specified special 
controls, in addition to general controls, were necessary to mitigate 
the risks to health for urogynecologic surgical mesh instrumentation, 
and as such, proposed to reclassify the device from class I to class II 
(79 FR 24634 at 24640). FDA continues to believe that there is 
sufficient information to establish special controls to provide a 
reasonable assurance of safety and effectiveness for this device, and 
thus does not believe this device should be reclassified into class 
III.
    FDA's new, more comprehensive, adverse event analysis provides 
further support for the risks to health of this device that FDA 
identified in the proposed order (see section I; Ref. 1), and the 
special controls established by FDA are specifically intended to 
mitigate those risks. For example, FDA's new MDR analysis revealed that 
failures of urogynecologic surgical mesh instrumentation (e.g., needle 
detachments, breaks, or bends; covering sheath breaks or tears) occur 
during both SUI and POP procedures, and these failures are associated 
with perioperative adverse events. The special control established at 
Sec.  884.4910(b)(4) addresses these failures and the risk of 
perioperative injuries by requiring a demonstration that the device 
meets all design specifications and performance requirements.
    Based on all of this information, the Panel consensus was that 
urogynecologic surgical mesh instrumentation meets the statutory 
definition of a class II device and does not meet the statutory 
definition of a class III device (see section I; Ref. 3).
    Because FDA has determined that general controls alone are not 
sufficient to provide a reasonable assurance of safety and 
effectiveness for this device, and there is sufficient information to 
establish special controls to provide such an assurance, FDA is 
reclassifying the device into class II.
    (Comment 2) One comment requested that urogynecologic surgical mesh

[[Page 1601]]

instrumentation have the same classification as the surgical mesh with 
which it is indicated to be used.
    (Response 2) Surgical mesh indicated for urogynecologic procedures 
is a class III device when it is indicated for transvaginal POP repair 
(see 81 FR 354; Sec.  884.5980) and a class II device when it is 
indicated for all other urogynecologic procedures, such as 
sacrocolpopexy and treatment of female SUI (see Sec.  878.3300). FDA 
characterized the risk profile of different kinds of urogynecologic 
surgical mesh instrumentation by analyzing adverse events associated 
with the use of this specialized instrumentation and stratifying them 
by the type of urogynecologic procedure for which they were used. The 
results indicate that the risk profile of urogynecologic surgical mesh 
instrumentation used with class III surgical mesh during transvaginal 
POP repair is comparable to that of urogynecologic surgical mesh 
instrumentation used with class II surgical mesh during other kinds of 
urogynecologic procedures (see section I; Ref. 1). Urogynecologic 
surgical mesh instrumentation used in all types of urogynecologic 
surgical mesh procedures appears to have a similar risk-benefit 
profile, and therefore FDA believes these devices should have the same 
classification.
    Moreover, as previously discussed, based on information included in 
the proposed order (79 FR 24634), FDA's comprehensive adverse event 
analysis (see Ref. 1), and the Panel's deliberations and 
determinations, FDA has determined that urogynecologic surgical mesh 
instrumentation is a class II device because general controls alone 
cannot provide a reasonable assurance of safety and effectiveness, but 
there is sufficient information to establish special controls to 
provide such assurance. As such, FDA is reclassifying these devices 
from class I to class II.
    (Comment 3) One comment stated that the scope of the urogynecologic 
surgical mesh instrumentation reclassification was unclear, and it 
could be interpreted that the reclassification applies only to 
instrumentation used for transvaginal POP repair rather than for 
instrumentation used for any urogynecologic surgical mesh procedure.
    (Response 3) FDA disagrees that the scope of the instrumentation 
reclassification was unclear in the May 1, 2014, proposed order. FDA 
included the description in the identification of urogynecologic 
surgical mesh instrumentation in proposed Sec.  884.4910(a) stating 
that surgical instrumentation for use with surgical mesh for 
urogynecological procedures is a prescription device used to aid in 
insertion, placement, fixation, or anchoring of surgical mesh for 
procedures including transvaginal POP repair, sacrocolpopexy 
(transabdominal POP repair), and treatment of female SUI. This 
description, which is not substantively changing in the final order, 
makes clear that all urogynecologic surgical mesh instrumentation--
whether used for transvaginal POP repair or other urogynecologic 
surgical mesh procedures--falls under this reclassification.
    (Comment 4) One comment stated that data provided in the proposed 
order to support the instrumentation reclassification was based only on 
POP procedures, that valid scientific evidence had not been provided to 
support the instrumentation reclassification, and that no evidence was 
provided to support the risks that were identified in the proposed 
order.
    (Response 4) First, FDA acknowledges that the data provided to 
support the instrumentation reclassification in the May 1, 2014, 
proposed order derived only from surgical mesh procedures indicated for 
POP. FDA subsequently conducted a new, more comprehensive analysis of 
perioperative adverse events associated with a variety of SUI 
procedures (retropubic, transobturator, mini-sling) and POP procedures 
(transvaginal repair and sacrocolpoplexy) by reviewing adverse events 
included in the relevant, scientific, published literature and adverse 
events submitted to the MDR database. Based on this analysis, FDA 
determined that perioperative adverse events occur during all types of 
SUI and POP procedures (see section I; Ref. 1). FDA also discovered 
that in the published literature, the highest reported rates of ``organ 
perforation and injury,'' ``vascular injury and bleeding,'' and ``nerve 
injury and pain'' were distributed across different types of 
urogynecologic surgical mesh procedures rather than only occurring 
during one specific type, such as transvaginal POP repair. FDA believes 
these results provide further support for the reclassification of these 
devices into class II, and also supports the scope of this 
reclassification, which encompasses specialized instrumentation used 
during all types of urogynecologic surgical mesh procedures. After 
presenting the proposed order and this new information to the Panel at 
the February 26, 2016, meeting, the Panel recommended that 
urogynecologic surgical mesh instrumentation be reclassified from class 
I (general controls) exempt from premarket notification to class II 
(special controls) (Ref. 3). FDA agrees with the Panel's 
recommendations and is reclassifying these devices from class I to 
class II.
    Second, FDA disagrees that valid scientific evidence was not 
provided in the May 1, 2014, proposed order to support reclassification 
of urogynecologic surgical mesh instrumentation. Valid scientific 
evidence is defined in Sec.  860.7(c)(2) as evidence from well-
controlled investigations, other types of studies and case histories 
conducted by qualified experts, and reports of significant human 
experience with a marketed device, from which it can fairly and 
responsibly be concluded by qualified experts that there is reasonable 
assurance of the safety and effectiveness of a device under its 
conditions of use. (See also section 513 of the FD&C Act). In the 
proposed order, FDA reviewed perioperative adverse events included in 
published studies of surgical mesh used during POP procedures. These 
publications constitute ``valid scientific evidence'' because they are 
controlled studies (Refs. 7-10, 12, 14) and collections of well-
documented case histories conducted by qualified experts (Refs. 4-6, 
11, 13).
    Finally, FDA disagrees that no evidence was provided to support the 
risks of urogynecologic surgical mesh instrumentation identified in the 
proposed order. In the proposed order, FDA specifically referenced 
clinical studies and systematic literature reviews in the published 
literature that included reports of perioperative adverse events (e.g., 
bleeding, hematoma, and blood loss; organ perforation; and 
neuromuscular problems) to support the proposed reclassification. 
Moreover, the risks of ``perioperative injury'' and ``pelvic pain and 
neuromuscular problems'' were also identified during FDA's search of 
the MAUDE database. As discussed in the proposed order, 843 reports in 
the MAUDE database analysis related to bleeding, hematoma, and blood 
loss; 42 reports related to organ perforation; and 196 reports of 
neuromuscular problems. FDA acknowledges that no data were provided to 
support the identified risks of ``infection'' and ``adverse tissue 
reaction.'' Although there are many possible causes for ``infection'' 
and ``adverse tissue reaction'' during a urogynecologic surgical mesh 
procedure, as FDA noted in the proposed order (see 79 FR 24634 at 
24639), FDA believes ``infection'' and ``adverse tissue reaction'' are 
general risks that apply to all devices that

[[Page 1602]]

contact the patient and need to be used sterile.
    As discussed throughout this document, FDA subsequently conducted a 
more comprehensive search of the relevant, scientific, published 
literature and MDR database to evaluate the risks of urogynecologic 
surgical mesh instrumentation. A summary of the findings from these 
reviews is in the Executive Summary (Ref. 1) and was provided in our 
presentation to the Panel on February 26, 2016 (Ref. 2). The findings 
from the literature review--which were confirmed by the MDR database 
review--provide further support for the risks identified and discussed 
in the proposed order.
    Based on this information, the Panel consensus was that the four 
risks to health of urogynecologic surgical mesh instrumentation that 
FDA identified in the proposed order is a complete and accurate list 
(Ref. 3).
    (Comment 5) One comment, which was submitted after the proposed 
order issued and before the Panel meeting was held, stated that the 
proposed order should be withdrawn until Panel input was obtained.
    (Response 5) FDA disagrees. The process followed by FDA in 
reclassifying this device is in accordance with section 513(e)(1) of 
the FD&C Act. This provision requires, in relevant part, that issuance 
of a final administrative order reclassifying a device be preceded by a 
proposed order and a meeting of a device classification panel. There is 
no requirement that a proposed order be ``withdrawn'' after its 
issuance but before the Panel meeting, and the rationale for doing so 
is not clear to FDA.

IV. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings 
as published in the proposed order for urogynecologic surgical mesh 
instrumentation, with the modifications discussed in section II of this 
document. For the reasons set forth in the proposed order and in this 
document, FDA concludes that general controls are insufficient to 
provide a reasonable assurance of safety and effectiveness for 
urogynecologic surgical mesh instrumentation, and there is sufficient 
information to establish special controls to provide such assurance.
    FDA is issuing this final order to reclassify urogynecologic 
surgical mesh instrumentation from class I (general controls) exempt 
from premarket notification to class II (special controls) and subject 
to premarket notification, and identifying them as ``specialized 
surgical instrumentation for use with urogynecologic surgical mesh.'' 
FDA is also establishing special controls, which are set forth in Sec.  
884.4910(b)(1) through (5).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act if FDA determines that premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of safety and 
effectiveness of urogynecologic surgical mesh instrumentation, and 
therefore, this device is not exempt from premarket notification 
requirements.

V. Implementation Strategy

    The order is effective January 6, 2017.
    Manufacturers of urogynecologic surgical mesh instrumentation that 
have not been legally marketed prior to January 6, 2017, must obtain 
510(k) clearance and demonstrate compliance with the special controls 
included in this final order before marketing the device.
    Manufacturers of urogynecologic surgical mesh instrumentation that 
have been legally marketed prior to January 6, 2017, must obtain 510(k) 
clearance and demonstrate compliance with the special controls included 
in this final order by January 8, 2018, for those devices if they wish 
to continue offering them for sale.

VI. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VII. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120 and the collections of 
information under 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

VIII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act 
provided for FDA to issue regulations to reclassify devices. Although 
section 513(e) of the FD&C Act as amended requires FDA to issue final 
orders rather than regulations, FDASIA also provides for FDA to revoke 
previously issued regulations by order. FDA will continue to codify 
classifications and reclassifications in the Code of Federal 
Regulations (CFR). Changes resulting from final orders will appear in 
the CFR as changes to codified classification determinations or as 
newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the 
FD&C Act, as amended by FDASIA, in this final order, we are codifying 
the reclassification of specialized surgical instrumentation for use 
with urogynecologic surgical mesh into class II in Sec.  884.4910.

IX. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

    1. Executive Summary of the February 26, 2016, meeting of the 
Gastroenterology-Urology Devices Panel (available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM487224.pdf).
    2. FDA presentation to Panel members at the February 26, 2016, 
meeting of the Gastroenterology-Urology Devices Panel (available at 
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM490205.pdf).
    3. Transcript of the February 26, 2016, meeting of the 
Gastroenterology-Urology Devices Panel (available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM491862.pdf).
    4. Caquant, F., et al., ``Safety of Trans Vaginal Mesh 
Procedure: Retrospective Study

[[Page 1603]]

of 684 Patients,'' Journal of Obstetrics and Gynecology Research, 
34(4):449-456, 2008.
    5. Maher, C.F., et al., ``Surgical Management of Pelvic Organ 
Prolapse in Women,'' Cochrane Database of Systematic Review, 4: 
CD004014, 2010.
    6. Diwadkar, G.B., et al., ``Complication and Reoperation Rates 
After Apical Vaginal Prolapse Surgical Repair: A Systematic 
Review,'' Obstetrics & Gynecology, 113(2 Pt. 1):67-73, 2009.
    7. Maher, C.F., et al., ``Laparoscopic Sacral Colpopexy Versus 
Total Vaginal Mesh for Vaginal Vault Prolapse: A Randomized Trial,'' 
American Journal of Obstetrics & Gynecology, 204(4):360.e1-360.e7, 
2011.
    8. Altman, D., et al., ``Anterior Colporrhaphy Versus 
Transvaginal Mesh for Pelvic-Organ Prolapse,'' New England Journal 
of Medicine, 364:1826-1836, 2011.
    9. Iglesia, C.B., et al., ``Vaginal Mesh for Prolapse: A 
Randomized Controlled Trial,'' Obstetrics & Gynecology, 116(2 Pt. 
1):293-303, 2010.
    10. Withagen, M.I., et al., ``Trocar-Guided Mesh Compared With 
Conventional Vaginal Repair in Recurrent Prolapse: A Randomized 
Controlled Trial,'' Obstetrics & Gynecology, 117(2 Pt. 1):242-250, 
2011.
    11. Sung, V.W., et al., Society of Gynecologic Surgeons 
Systematic Review Group. ``Graft Use in Transvaginal Pelvic Organ 
Prolapse and Urinary Incontinence,'' Obstetrics & Gynecology, 
112(5):1131-1142, 2008.
    12. Hiltunen, R., et al., ``Low-Weight Polypropylene Mesh for 
Anterior Vaginal Wall Prolapse: A Randomized Controlled Trial,'' 
Obstetrics & Gynecology, 110(2 Pt. 2):455-462, 2007.
    13. Jia, X., et al., ``Efficacy and Safety of Using Mesh or 
Grafts in Surgery for Anterior and/or Posterior Vaginal Wall 
Prolapse: Systematic Review and Meta-Analysis,'' British Journal of 
Obstetrics and Gynecology, 115:1350-1361, 2008.
    14. Sivaslioglu, A.A., E. Unlubilgin, and I. Dolen, ``A 
Randomized Comparison of Polypropylene Mesh Surgery With Site-
Specific Surgery in the Treatment of Cystocoele,'' International 
Urogynecology Journal and Pelvic Floor Dysfunction, 19(4):467-471, 
2008.

List of Subjects in 21 CFR Part 884

    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 
884 is amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for part 884 continues to read as follows:

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

0
2. Add Sec.  884.4910 to subpart E to read as follows:


Sec.  884.4910   Specialized surgical instrumentation for use with 
urogynecologic surgical mesh.

    (a) Identification. Specialized surgical instrumentation for use 
with urogynecologic surgical mesh is a prescription device specifically 
intended for use as an aid in the insertion, placement, fixation, or 
anchoring of surgical mesh during urogynecologic procedures. These 
procedures include transvaginal pelvic organ prolapse repair, 
sacrocolpopexy (transabdominal pelvic organ prolapse repair), and 
treatment of female stress urinary incontinence. Examples of 
specialized surgical instrumentation include needle passers and 
trocars, needle guides, fixation tools, and tissue anchors. This device 
is not a manual gastroenterology-urology surgical instrument and 
accessories (Sec.  876.4730) or a manual surgical instrument for 
general use (Sec.  878.4800).
    (b) Classification. Class II (special controls). The special 
controls for specialized surgical instrumentation for use with 
urogynecologic surgical mesh are:
    (1) The device must be demonstrated to be biocompatible;
    (2) The device must be demonstrated to be sterile and, if reusable, 
it must be demonstrated that the device can be adequately reprocessed;
    (3) Performance data must support the shelf life of the device by 
demonstrating package integrity and device functionality over the 
requested shelf life;
    (4) Non-clinical performance testing must demonstrate that the 
device meets all design specifications and performance requirements, 
and that the device performs as intended under anticipated conditions 
of use; and
    (5) Labeling must include:
    (i) Information regarding the mesh design that may be used with the 
device;
    (ii) Detailed summary of the clinical evaluations pertinent to use 
of the device;
    (iii) Expiration date; and
    (iv) Where components are intended to be sterilized by the user 
prior to initial use and/or are reusable, validated methods and 
instructions for sterilization and/or reprocessing of any reusable 
components.

    Dated: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31862 Filed 1-5-17; 8:45 am]
 BILLING CODE 4164-01-P