[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Proposed Rules]
[Pages 17116-17124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2019-N-1250]


General and Plastic Surgery Devices; Reclassification of Certain 
Surgical Staplers

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
proposing to reclassify surgical staplers for internal use (currently 
regulated under the classification for ``manual surgical instrument for 
general use'' and assigned the product code GAG) from class I (general 
controls) into class II (special controls) and subject to premarket 
review. FDA is identifying the proposed special controls for surgical 
staplers for internal use that the Agency believes are necessary to 
provide a reasonable assurance of the safety and effectiveness of the 
device. FDA is proposing this reclassification on its own initiative 
based on new information. As part of this reclassification, FDA is also 
proposing to amend the existing classification for ``manual surgical 
instrument for general use'' to remove staplers and to create a 
separate classification regulation for surgical staplers that 
distinguishes between surgical staplers for internal use and external 
use.

DATES: Submit either electronic or written comments on the proposed 
order by June 24, 2019. Please see section XI of this document for the 
proposed effective date of any final order that may publish based on 
this proposed order.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 24, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 24, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal Rulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-1250 for ``General and Plastic Surgery Devices; 
Reclassification of Certain Surgical Staplers.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: R. Dale Rimmer, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G425, Silver Spring, MD 20993, 240-402-4828, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, 
establishes 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

[[Page 17117]]

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).
    Section 513(a)(1) of the FD&C Act defines the three classes of 
devices. Class I devices are those devices for which the general 
controls of the FD&C Act (controls authorized by or under section 501, 
502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 
360i, or 360j) or any combination of such sections) are sufficient to 
provide reasonable assurance of safety and effectiveness; or those 
devices for which insufficient information exists to determine that 
general controls are sufficient to provide reasonable assurance of 
safety and effectiveness or to establish special controls to provide 
such assurance, but because the devices are not purported or 
represented to be for a use in supporting or sustaining human life or 
for a use which is of substantial importance in preventing impairment 
of human health, and do not present a potential unreasonable risk of 
illness or injury, are to be regulated by general controls (section 
513(a)(1)(A) of the FD&C Act). Class II devices are those devices for 
which general controls by themselves are insufficient to provide 
reasonable assurance of safety and effectiveness, and for which there 
is sufficient information to establish special controls to provide such 
assurance, including the promulgation of performance standards, 
postmarket surveillance, patient registries, development and 
dissemination of guidelines, recommendations, and other appropriate 
actions the Agency deems necessary to provide such assurance (section 
513(a)(1)(B) of the FD&C Act). Class III devices are those devices for 
which insufficient information exists to determine that general 
controls and special controls would provide a reasonable assurance of 
safety and effectiveness, and which are purported or represented to be 
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 
which present a potential unreasonable risk of illness or injury 
(section 513(a)(1)(C) of the FD&C Act).
    Under section 513(d)(1) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments 
(Medical Device Amendments of 1976, Pub. L. 94-295), May 28, 1976 
(generally referred to as ``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 before May 28, 
1976 (generally referred to as ``postamendments devices''), are 
automatically classified by section 513(f)(1) of the FD&C Act into 
class III without any FDA rulemaking process. Those devices remain in 
class III and require premarket approval, unless, and until: (1) FDA 
reclassifies the device into class I or II or (2) FDA issues an order 
finding the device to be substantially equivalent, in accordance with 
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 previously marketed devices by means of 
premarket notification procedures in section 510(k) of the FD&C Act and 
part 807, subpart E of the regulations (21 CFR part 807).
    On July 9, 2012, Congress enacted the Food and Drug Administration 
Safety and Innovation Act (FDASIA) (Pub. L. 112-144). Section 608(a) of 
FDASIA amended section 513(e) of the FD&C Act, changing the process for 
reclassifying a device from rulemaking to an administrative order. 
Section 513(e)(1)(A)(i) of the FD&C Act sets forth the process for 
issuing a final order. Specifically, prior to the issuance of an 
administrative order reclassifying a device, the following must occur: 
(1) Publication of a proposed reclassification order in the Federal 
Register, (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. The proposed reclassification order must set forth the 
proposed reclassification and a substantive summary of the valid 
scientific evidence concerning the proposed reclassification, including 
the public health benefits of the use of the device, and the nature and 
incidence (if known) of the risks of the device.
    Section 513(e)(1)(A)(i) provides that FDA may, by administrative 
order, reclassify a device based on ``new information.'' FDA can 
initiate a reclassification under section 513(e) or an interested 
person may petition FDA. 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 v. 
United States Dep't of Health, Educ. & Welfare, 587 F.2d 1173, 1174 n.1 
(D.C. Cir. 1978); Upjohn Co. 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 regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, 366 F.2d 177, 181 (7th Cir. 1966)) or in light of 
changes in ``medical science'' (see Upjohn Co. v. Finch, 422 F.2d 944, 
951 (6th Cir. 1970)). Whether data before the Agency are old or new, 
the ``new information'' to support reclassification under section 
513(e) of the FD&C Act must be ``valid scientific evidence'', as 
defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). 
(See, e.g., General 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)).
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. 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 (see section 520(c) of the FD&C Act).
    Section 510(m) of the FD&C Act provides that a class II device may 
be exempted from the premarket notification requirements under section 
510(k) of the FD&C Act if the Agency determines that premarket 
notification is not necessary to assure the safety and effectiveness of 
the device. FDA has determined that premarket notification is necessary 
to reasonably assure the safety and effectiveness of surgical staplers 
for internal use. Therefore, the Agency does not intend to exempt this 
proposed class II device from premarket notification (510(k)) 
submission as provided under section 510(m) of the FD&C Act.

II. Regulatory History of the Devices

    Surgical staplers were classified in part 878 (21 CFR part 878) in 
a final rule published in the Federal Register on June 24, 1988 (53 FR 
23856), that classified 51 general and plastic surgery devices. This 
1988 rule classified staplers into class I (general controls).

[[Page 17118]]

These devices were grouped with other devices under ``Manual surgical 
instrument for general use'' in Sec.  878.4800 (21 CFR 878.4800). At 
the time, surgical staplers had been in common use in medical practice 
for many years, and FDA believed that general controls were sufficient 
to provide reasonable assurance of the safety and effectiveness of 
those devices. This rule was amended on April 5, 1989 (54 FR 13826), to 
clarify that manual surgical instruments for general use, Sec.  
878.4800, made of the same materials as used in the preamendments 
devices were exempt from premarket notification (510(k)) review.
    On December 7, 1994, FDA further amended the classification when it 
published a final rule in the Federal Register (59 FR 63005) that 
exempted 148 class I devices from premarket notification, with 
limitations. Surgical staplers were one of those exempted devices. FDA 
determined that manufacturers' submissions of premarket notifications 
were unnecessary for the protection of the public health and that FDA's 
review of such submissions would not advance its public health mission.
    On March 8, 2019, FDA issued a letter to healthcare providers to 
inform them of the risks associated with misuse of surgical staplers 
and to provide recommendations for reducing the risk of adverse events 
associated with these devices (Ref. 1). This letter recommends that 
users carefully follow the stapler manufacturer's instructions for use 
and provides additional recommendations for selecting the appropriate 
staple sizes and tissue types appropriate for use with the stapler.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice of availability for a draft guidance entitled ``Surgical 
Staplers and Staples for Internal Use--Labeling Recommendations; Draft 
Guidance for Industry and Food and Drug Administration Staff.'' As 
identified in this draft guidance, FDA has become aware of a large 
number of adverse events associated with surgical staplers and staples 
for internal use. This draft guidance communicates FDA's 
recommendations for contraindications, warnings, directions for use, 
and technical characteristics and performance parameters to be included 
in the product labeling to help promote the safe and effective use of 
surgical staplers and staples for internal use. This draft guidance 
also provides recommendations for content to be included in the package 
labels, so that users may easily look at the label and obtain critical 
information necessary for proper device selection.
    Surgical staples are currently regulated as class II devices under 
21 CFR 878.4750 (Implantable staple) and are subject to premarket 
notification (510(k)) review. FDA does not intend to change the 
classification of surgical staples at this time and they are outside 
the scope of this reclassification action.

III. Device Description

    A surgical stapler is a specialized prescription device used to 
deliver compatible staples during surgery. Prescription devices are 
exempt from the requirement for adequate directions for use for the 
layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as 
long as the conditions of 21 CFR 801.109 are met.
    To delineate between surgical staplers and their intended uses, FDA 
has identified two subsets of surgical staplers: (1) Surgical staplers 
for internal use and (2) surgical staplers for external use.
    A surgical stapler for internal use is a specialized prescription 
device used to deliver compatible staples to internal tissues during 
surgery for removing part of an organ (i.e., resection), cutting 
through organs and tissues (i.e., transection), and creating 
connections between structures (i.e., anastomoses). It may be used in 
open, minimally invasive, and endoscopic surgery. Surgical staplers for 
internal use may be indicated for use in a wide range of surgical 
applications, including, but not limited to, gastrointestinal, 
gynecologic, and thoracic surgery.
    Many types of surgical staplers for internal use exist, including, 
but not limited to, linear non-cutting staplers, transverse 
approximating staplers, transverse anastomoses staplers, 
gastrointestinal anastomoses linear cutting (articulating and non-
articulating) staplers, and circular (i.e., end-to-end anastomoses) 
staplers. Surgical staplers for internal use include both manual and 
powered staplers.
    A surgical stapler for external use is a specialized prescription 
device used to deliver compatible staples to skin during surgery. FDA 
is proposing to reclassify internal staplers only; external staplers 
will remain class I, exempt from premarket review.

IV. Proposed Reclassification

    FDA is proposing to reclassify surgical staplers for internal use 
from class I (general controls), exempt from premarket review, to class 
II (special controls), subject to premarket review. FDA believes that 
general controls by themselves are insufficient to provide reasonable 
assurance of safety and effectiveness for these devices, and that there 
is sufficient information to establish special controls to provide such 
assurance. In accordance with section 513(e)(1)(A)(i) of the FD&C Act, 
FDA, on its own initiative, is proposing to reclassify these devices 
based on new information. The process for issuing a final order for 
reclassification of a device from class I to class II pursuant to 
section 513(e) of the FD&C Act is provided in 21 CFR 860.130 of the 
regulations. Specifically, prior to the issuance of a final order 
reclassifying a device, the following must occur: (1) Publication of a 
proposed reclassification order in the Federal Register; (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. The 
Commissioner of Food and Drugs is required to consult with a 
classification panel and may secure a recommendation with respect to 
the reclassification of the device. FDA will consult with the panel 
regarding the reclassification of the device in accordance with the 
procedures set forth in 21 CFR 860.125 and intends to secure the 
panel's recommendation. If FDA issues a final order, the Agency will 
publish the panel's recommendation in the Federal Register when the 
Agency publishes the final order.
    FDA is also proposing to revise Sec.  878.4800 (Manual surgical 
instrument for general use) to remove staplers and to create a separate 
classification regulation in part 878 for surgical staplers that 
distinguishes between surgical staplers for internal use and external 
use.

V. Public Health Benefits and Risks to Health

    As required by section 513(e)(1)(A)(i) of the FD&C Act, FDA is 
providing a substantive summary of the valid scientific evidence 
concerning the proposed reclassification including the public health 
benefit of the use of surgical staplers for internal use, and the 
nature, and if known, the incidence of the risk of the devices, as 
discussed in section VI of this proposed order.
    Surgical staplers for internal use provide benefit to the public 
health by facilitating surgical procedures and allowing for shorter 
surgical procedure times compared to manual suturing.
    FDA has evaluated the risks to health associated with the use of 
surgical staplers for internal use and has identified the following 
risks for this device:

[[Page 17119]]

     Complications associated with device failure/malfunction. 
Device failures or malfunctions may result in prolonged surgical 
procedures, unplanned surgical interventions, and other complications 
such as bleeding, sepsis, fistula formation, tearing of internal 
tissues and organs, increased risk of cancer recurrence, and death.
     Complications associated with use error/improper device 
selection and use. Use error may result from a device design that is 
difficult to operate and/or labeling that is difficult to comprehend. 
For example, user difficulty in firing the stapler may result in 
staples not being fully deployed, and misfiring may result in staples 
being inadvertently applied to the wrong tissue. Inadequate 
instructions for use may result in selection of incorrectly sized 
staples for the target tissue. When staples are applied to the wrong 
tissue or when incorrectly sized staples are applied, staples are 
unable to properly approximate the underlying tissue, resulting in 
tissue damage, anastomotic leakage, and bleeding. This in turn, may 
lead to more severe complications, such as abscess, sepsis, 
peritonitis, hemorrhage, or death.
     Adverse tissue reaction. If the patient-contacting 
materials of the device are not biocompatible, local tissue irritation 
and sensitization, cytotoxicity, or systemic toxicity may occur when 
the device contacts sterile tissue.
     Infection. If the device is not adequately reprocessed or 
sterilized, the device may introduce pathogenic organisms into sterile 
tissue and may cause an infection in a patient.
    As discussed further in this document, these findings regarding the 
public health benefits and risks to health associated with surgical 
staplers for internal use are based on publicly available information, 
including Medical Device Reporting (MDR) analyses, recalls, and the 
published literature.

VI. Summary of Data Upon Which the Reclassification Is Based

    Surgical staplers for internal use have been shown to provide 
several benefits over manual suturing, including reduction in surgical 
time, reduced tissue trauma/manipulation, reduction in surgical 
contamination by intestinal contents, and simple closure of vessels 
and/or tissues (Ref. 2); however, they have also been associated with 
numerous adverse events.
    As discussed below, based on a review of the MDR database, recalls 
database, and the published scientific literature, there have been many 
malfunctions and other problems associated with surgical staplers for 
internal use, and some of these malfunctions or other problems have 
been associated with serious complications, including death.
    Because surgical staplers are used together with staples as a 
system, a search of the MDR database was conducted for both surgical 
staplers for internal use under product code GAG (Stapler, Surgical) 
and surgical staples for internal use under product code GDW (Staple, 
Implantable) to obtain a comprehensive picture of the safety profile 
for surgical staplers for internal use. From January 1, 2011, to March 
31, 2018, FDA received over 41,000 individual MDRs for surgical 
staplers and staples for internal use, including 366 deaths, over 9,000 
serious injuries, and over 32,000 malfunctions. Some of the most 
commonly reported problems in these adverse event reports include an 
opening of the staple line or malformation of staples, misfiring, 
difficulty in firing, failure of the stapler to fire the staple, and 
misapplied staples (e.g., user applying staples to the wrong tissue or 
applying staples of the wrong size to tissue). Although the majority of 
the adverse events were reported under product code GDW, FDA believes 
that many of the problems identified in these reports can be primarily 
attributed to surgical staplers for internal use, since proper staple 
formation is largely contingent on proper function and use of the 
stapler.
    Of the 366 deaths, the cause of death was associated with an 
opening of the staple line or malformation of staples in 159 reports, 
bleeding during surgery in 53 reports, sepsis in 47 reports, 
peritonitis in 5 reports, necrosis in 5 reports, and air embolism in 4 
reports. Additionally, of the 366 deaths, 195 reports included 
misfiring, difficulty in firing, and/or misapplied staples. Common 
reasons cited for these problems included mechanical issues with the 
device (e.g., mechanical jams), broken device components, and the 
device operating differently than the user expected (e.g., different 
force needed to deploy the device than expected). In 11 of the 366 
deaths, use error was determined to be a contributing factor to the 
death. Many of the same complications that resulted in death (e.g., 
bleeding during surgery, peritonitis, and sepsis) were also reported in 
the serious injury reports; additional complications commonly reported 
in the serious injury reports included tissue damage, organ perforation 
or dehiscence, fistula formation, infection, hernia, and pain.
    The majority of staplers reported in these adverse events were 
linear staplers, including articulating and curved tip linear staplers, 
followed by circular staplers. Of the 366 deaths, 262 deaths were 
reported for linear staplers while 63 were reported for circular 
staplers; of the remaining 41 deaths, a type of stapler was not 
identified in the MDR. The staplers involved in these adverse events 
spanned a variety of different manufacturers; there were no distinct 
differences between manufacturers and the reported causes of death.
    Of the 41,000 individual MDRs, over 32,000 MDRs were received for 
malfunctions, under either the product code GAG (Stapler, Surgical) or 
product code GDW (Staple, Implantable). The most common device-related 
malfunctions included failure of the stapler to fire the staple, 
failure to form staples, difficulty of opening/closing the stapler, 
stapler misfiring, and stapler breakage. The most commonly reported 
patient consequences from malfunctions with surgical staplers for 
internal use included a delay in surgical procedure, hemorrhage, and 
tissue damage. It should be noted that some patient consequences may 
not be limited to a single reporting category of death, serious injury, 
or malfunction. For example, a malfunction could result in sepsis, 
which could lead to other serious injury and later death.
    The types and incidence of malfunctions and clinical consequences 
to patients seen in the adverse event reports are also corroborated by 
the published literature. In a systematic review of 30 clinical studies 
(Refs. 3 to 32), including randomized controlled trials and 
observational studies, the occurrence of stapler malfunctions in these 
studies ranged from incidents in 0 to 19.2 percent (median = 1.8 
percent) of patients and 0.1 to 5.2 percent of deployments.
    Consistent with the malfunctions seen in the adverse event reports 
received by FDA, the most common malfunctions reported in these 
clinical studies were related to opening of the staple line or 
malformation of staples. In these studies, malformed staples and/or 
staple lines comprised 31.8 percent of the malfunctions, while missing 
staples and/or staple lines not forming comprised 19.5 percent of the 
malfunctions. Problems with stapler firing and/or stapler function were 
also commonly reported. Device sticking, locking, and/or jamming 
comprised 15.9 percent of the malfunctions, while stapler misfiring 
comprised 10.3 percent of the malfunctions. Inability of the stapler to 
cut through tissue comprised

[[Page 17120]]

3.1 percent of the malfunctions, while stapler breakage comprised 2.6 
percent of all malfunctions. Finally, problems with the stapler 
cartridge not loading properly comprised 2.1 percent of the 
malfunctions. Although the majority of studies in the systematic 
literature review did not report on the incidence of stapler problems 
associated with use error, a prospective, single-arm study evaluating 
use of a surgical stapler in gastrointestinal stapling applications 
found that 3.5 percent of stapler deployments in the study (15 of 423 
deployments) were attributed to use error (Ref. 10). Additionally, as 
discussed further below, common causes for surgical complications 
reported in the literature include use error.
    While 75.8 percent of the stapler malfunctions in these studies did 
not result in any major consequences to the patient, 10.5 percent of 
the malfunctions resulted in the need to convert to open surgery, while 
9.7 percent of the malfunctions resulted in hemorrhage; 4.0 percent of 
the malfunctions resulted in both hemorrhage and the need to convert to 
open surgery. In addition, multiple studies suggest that surgical 
stapler malfunctions are associated with a higher risk of 
complications. In a retrospective study of 349 colorectal resections 
using a circular stapler, surgeries with surgical stapler malfunctions 
were found to have higher incidences of unplanned proximal diversions, 
ileus, gastrointestinal bleeding, and blood transfusions (Ref. 27). In 
a retrospective study of 1,174 patients undergoing liver transections 
using a stapler device, surgeries with surgical stapler malfunctions 
were found to have a higher likelihood of transfusion, higher median 
blood loss, and higher odds of morbidity and mortality compared to 
surgeries without stapler malfunctions (Ref. 28). Anastomotic leaks 
from surgical stapler malfunctions have also been associated with an 
increased risk of cancer recurrence (Refs. 33 to 35). Altogether, the 
adverse event reports and published literature indicate that surgical 
stapler malfunctions are not uncommon and may produce adverse outcomes 
such as conversion to open surgery, bleeding, morbidity, and death.
    Common causes for surgical complications reported in the literature 
also include the use of incorrectly sized staples for the tissue, 
incorrect use of the device by the user, and improper use of the device 
for the condition of the patient's tissues, which may result in 
reoperation or prolonged hospitalization (Ref. 36). For example, early 
postoperative anastomotic leak due to such device issues may result in 
a septic patient with peritonitis, requiring immediate surgery with 
diversion of stool into a stoma. Minor or delayed anastomotic leaks due 
to such device issues may result in an intra-abdominal abscess 
requiring surgical or other invasive drainage procedures, temporary 
diversion of stool, and prolonged intravenous nutrition. These 
complications commonly result in prolonged hospital stays (Ref. 37). 
Altogether, the adverse event reports and published literature indicate 
that surgical stapler for internal use use error may cause or 
contribute to surgical complications, e.g., anastomotic leaks, abscess, 
sepsis, peritonitis, and death.
    From November 1, 2002, to December 30, 2018, FDA received a total 
of 168 recalls for surgical staplers and staples for internal use under 
product codes GAG and GDW, including one class I recall and 167 class 
II recalls. The class I recall was for a hemorrhoidal circular stapler 
that may result in incomplete staple formation due to difficulty in 
firing. Of the 167 class II recalls, the most common reasons for recall 
included non-conforming device components or device design-related 
issues that may result in incomplete staple formation, failure to form 
a staple line, malformed staples, or difficulty in firing. Several 
devices were also recalled due to a potential breach in sterility.
    FDA acknowledges that the available valid scientific evidence, 
including the review of the MDR database, recalls database, and the 
published literature, primarily discuss surgical staplers for internal 
use, and not surgical staplers for external use. At this time, FDA does 
not believe that available information suggests that reclassification 
of surgical staplers for external use is necessary to maintain a 
reasonable assurance of safety and effectiveness of these devices.
    Based on its review of the MDR database, recalls database, and the 
published literature, FDA has tentatively determined that special 
controls, in addition to general controls, are necessary to provide a 
reasonable assurance of safety and effectiveness for surgical staplers 
for internal use. FDA believes the establishment of special controls is 
necessary to ensure that the risks to health are adequately mitigated 
by an assessment of these devices through completion of performance 
testing, usability and labeling comprehension testing, biocompatibility 
evaluation, sterility and shelf-life testing, and adequate labeling. In 
addition, FDA believes that design controls under 21 CFR 820.30 are 
necessary to ensure that specified design requirements are met and to 
ensure compatibility of surgical staplers for internal use with 
staples. Therefore, FDA, on its own initiative, is proposing to 
reclassify these devices from class I into class II (special controls) 
subject to premarket review.

VII. Summary of Reasons for Reclassification

    Based on the information reviewed by FDA, including the valid 
scientific evidence regarding the public health benefit and nature and 
incidence of the risk of the devices discussed in section VI, FDA 
tentatively concludes that special controls, in addition to general 
controls, are necessary to provide a reasonable assurance of safety and 
effectiveness for surgical staplers for internal use. Therefore, FDA 
proposes to reclassify surgical staplers for internal use from class I 
into class II (special controls).

VIII. Proposed Special Controls

    FDA believes that the following special controls, together with 
general controls, are necessary and sufficient to mitigate the risks to 
health described in section V (complications associated with device 
failure/malfunction, complications associated with use error/improper 
device selection and use, adverse tissue reaction, and infection) and 
provide a reasonable assurance of safety and effectiveness for surgical 
staplers for internal use.
    Both device misuse and device malfunctions are root causes of the 
adverse events associated with use of surgical staplers for internal 
use (Ref. 38). Device misuse may be exacerbated by inadequate 
instructions for use and insufficient warnings or precautions in the 
device labeling (Ref. 39). To mitigate the risks of tissue damage, 
anastomotic leakage, and bleeding arising from use error or improper 
device use, FDA believes that the labeling must include specific 
instructions for device use, including procedures associated with 
proper device use and measures for preventing device malfunction, 
evaluating the appropriateness of the target tissue for stapling, and 
evaluating the resultant staple line. To further mitigate these risks, 
the labeling must also include appropriate warnings, contraindications, 
and limitations needed for safe use of the device. To prevent stapler 
malfunction (e.g., from stapler jamming, locking, sticking, or 
misfiring), information on the staples with which the stapler is 
compatible must be provided in the labeling, such as models of 
compatible staples, cartridge colors/staple heights, staple rows per 
cartridge, staple patterns, and

[[Page 17121]]

maximum and minimum tissue thicknesses for each staple type. To prevent 
improper application of staples to target tissue, the recommended 
tissues (e.g., tissue thicknesses and tissue types) on which the 
stapler is intended to be used must be identified in the labeling. 
Unless data demonstrates the safety of doing so, contraindications must 
be identified regarding use of the device on tissues for which the risk 
of stapling outweighs any reasonably foreseeable benefit due to known 
complications, including the stapling of necrotic or ischemic tissues 
and tissues outside of the labeled limits of tissue thickness. The 
labeling must provide appropriate warnings regarding how to avoid known 
hazards associated with device use, including avoidance of obstructions 
to the creation of a staple line (e.g., clips) and the unintended 
stapling of other anatomic structures; avoidance of clamping and 
unclamping of delicate tissue structures (e.g., venous structures and 
bile ducts) to prevent tissue damage; avoidance of use of the stapler 
on large blood vessels, such as the aorta; establishing and maintaining 
proximal control of blood vessels prior to stapling; appropriate 
measures to take if a stapler malfunction occurs while applying staples 
across a blood vessel, such as clamping or ligating the vessel before 
releasing the stapler, while the stapler is still closed on the tissue; 
and ensuring stapler compatibility with staples, unless information is 
provided demonstrating that the warnings do not apply to a particular 
device. Usability testing and a labeling comprehension study must 
demonstrate that the clinician can correctly select and use the device 
for its indicated use based on the information in the labeling.
    To mitigate the risk of complications associated with device 
failure or device malfunction, adequate performance testing is needed 
to ensure that the stapler with compatible staples performs as intended 
under anticipated conditions of use. FDA believes that adequate 
performance testing must include an evaluation of staple formation 
characteristics in the maximum and minimum tissue thicknesses for each 
staple type; measurement of the worst-case deployment pressures on 
stapler firing force; and a measurement of staple line strength. 
Performance testing must also demonstrate confirmation of staple line 
integrity (e.g., through the absence of vertically contiguous malformed 
staples), as well as in vivo confirmation of staple line hemostasis 
following staple deployment.\1\
---------------------------------------------------------------------------

    \1\ FDA supports the principles of the ``3Rs,'' to reduce, 
refine, and replace animal use in testing when feasible. FDA 
encourages sponsors to consult with FDA if they wish to use a non-
animal testing method they believe is suitable, adequate, validated, 
and feasible. FDA will consider if such an alternative method could 
be assessed for equivalency to an animal test method.
---------------------------------------------------------------------------

    FDA believes that the inclusion of important technical 
characteristics and device performance parameters in the labeling will 
also help mitigate use error and device malfunctions by informing end 
users on device limitations. Therefore, FDA believes that the labeling 
must identify key technical characteristics and performance parameters 
of the surgical stapler and compatible staples needed for safe use of 
the device. Key technical characteristics include stapler 
specifications (e.g., jaw length, shaft length, jaw opening, and angles 
of articulation), as well as compatible staple specifications (e.g., 
open and closed staple heights). Key technical characteristics also 
include identification of any safety mechanisms of the stapler, such as 
a color-firing zone and/or lock-out mechanism. Examples of key 
performance parameters include information on firing the stapler, such 
as the firing force, pre-fire compression time, and maximum number of 
consecutive firings, and information relevant to creating a staple 
line, such as the percentage of properly formed staples, number of 
incremental firings required to complete a staple line, and maximum 
number of reloads.
    FDA believes that the device must be demonstrated to be 
biocompatible because the risk of adverse tissue reaction may result 
from contact of the materials of the device with the body. 
Additionally, because the risk of infection can arise from a 
contaminated device, sterility testing must demonstrate the sterility 
of the device. If any components of the device are reusable, the 
labeling must include validated methods and instructions for cleaning 
and sterilization of these reusable components. Validation of cleaning 
and sterilization instructions must demonstrate that any reusable 
device components can be safely and effectively reprocessed per the 
recommended cleaning and sterilization protocol in the labeling.
    In addition, loss of package integrity can result in compromised 
sterility and compromised device performance over time. Therefore, 
shelf-life testing must demonstrate that the device maintains its 
performance characteristics and the packaging of the device maintains 
its integrity for the duration of the proposed shelf-life. Finally, the 
labeling must also specify an expiration date to inform users of the 
shelf-life of the device based on the shelf-life testing.
    Table 1 shows how FDA believes each risk to health described in 
section V would be mitigated by the proposed special controls.

 Table 1--Risks to Health and Mitigation Measures for Surgical Staplers
                            for Internal Use
------------------------------------------------------------------------
       Identified risks to health              Mitigation measures
------------------------------------------------------------------------
Complications associated with device     Performance testing and
 failure/malfunction.                     Labeling.
Complications associated with use error/ Usability testing, Labeling
 improper device selection and use.       comprehension study, and
                                          Labeling.
Adverse Tissue Reaction................  Biocompatibility evaluation.

[[Page 17122]]

 
Infection..............................  Labeling, Sterility testing,
                                          and Shelf-Life testing.
------------------------------------------------------------------------

    If finalized, the reclassification of surgical staplers for 
internal use into class II would subject these devices to premarket 
notification under section 510(k) of the FD&C Act and part 807, subpart 
E, and the identified special controls in this order. FDA believes that 
the proposed reclassification would provide reasonable assurance of 
safety and effectiveness of surgical staplers for internal use.

IX. 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.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed order contains no new 
collections of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520) is not required. This proposed order refers 
to previously approved collections of information found in FDA 
regulations. These collections of information are subject to review by 
OMB under the PRA. The collections of information in part 807, subpart 
E, have been approved under OMB control number 0910-0120; the 
collections of information in 21 CFR part 814, subparts A through E, 
have been approved under OMB control number 0910-0231; the collections 
of information in 21 CFR part 801 have been approved under OMB control 
number 0910-0485; and the collections of information in 21 CFR part 820 
have been approved under OMB control number 0910-0073.

XI. Proposed Effective Date

    FDA proposes that any final order based on this proposed order 
become effective on its date of publication in the Federal Register.
     Surgical staplers for internal use that have not been 
offered for sale prior to the effective date of the final order or have 
been offered for sale but are required to submit a new 510(k) under 21 
CFR 807.81(a)(3): Manufacturers would have to obtain 510(k) clearance 
before marketing their devices after the effective date of the order. 
If a manufacturer markets such a device without receiving 510(k) 
clearance, then FDA would consider taking action against such a 
manufacturer under its usual enforcement policies.
     Surgical staplers for internal use that have been offered 
for sale prior to the effective date of the final order and do not 
already have 510(k) clearance: FDA does not intend to enforce 
compliance with the 510(k) requirement or special controls until 180 
days after the effective date of the final order. After that date, if a 
manufacturer continues to market such a device but does not have 510(k) 
clearance or FDA determines that the device is not substantially 
equivalent or not compliant with special controls, then FDA would 
consider taking action against such manufacturer under its usual 
enforcement policies.
    For surgical staplers for internal use that have prior 510(k) 
clearance, FDA would accept a new 510(k) and would issue a new 
clearance letter, as appropriate, indicating substantial equivalence 
and special controls compliance. These devices could serve as 
predicates for new devices. These clearance letters would be made 
publicly available in FDA's 510(k) database, and compliance with 
special controls at the time of clearance would also be stated in the 
publicly available 510(k) Summary posted in this database. FDA believes 
that our public database is a transparent tool allowing users to 
confirm that their devices have been submitted under a new 510(k) and 
demonstrated conformance to applicable special controls.

XII. 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) as amended requires FDA to issue final orders rather 
than regulations, it 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), as amended by FDASIA, in the 
proposed order, we are proposing to revoke the classification of 
surgical staplers in Sec.  878.4800 and to codify surgical staplers in 
the new 21 CFR 878.4740, under which surgical staplers for internal use 
would be reclassified into class II and surgical staplers for external 
use would remain in class I.

XIII. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; references 
with website addresses are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.

1. FDA, ``Safe Use of Surgical Staplers and Staples--Letter to 
Health Care Providers,'' March 8, 2019, available at https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm632938.htm.
2. Lipscomb, V., ``Surgical Staplers: Toy or Tool?'' In Practice. 
2012; 34: 472-479.
3. Yim, A.P. and J.K. Ho, ``Malfunctioning of Vascular Staple Cutter 
During Thoracoscopic Lobectomy.'' The Journal of Thoracic and 
Cardiovascular Surgery. 1995;109(6):1252.
4. Angrisani, L., M. Lorenzo, V. Borrelli, et al., ``The Use of 
Bovine Pericardial Strips on Linear Stapler to Reduce Extraluminal 
Bleeding During Laparoscopic Gastric Bypass: Prospective Randomized 
Clinical Trial.'' Obesity Surgery. 2004;14(9):1198-1202.
5. Champion, J.K. and M.D. Williams, ``Prospective Randomized 
Comparison of Linear Staplers During Laparoscopic Roux-en-Y Gastric 
Bypass.'' Obesity Surgery. 2003;13(6):855-859.
6. Nguyen, N.T., M. Longoria, S. Welbourne, et al., ``Glycolide 
Copolymer Staple-Line Reinforcement Reduces Staple Site Bleeding 
During Laparoscopic Gastric Bypass: A Prospective Randomized 
Trial.'' Archives of Surgery. 2005;140(8):773-778.
7. Abu-Ghanem, Y., C. Meydan, L. Segev, et al., ``Gastric Wall 
Thickness and the Choice of Linear Staples in Laparoscopic Sleeve 
Gastrectomy: Challenging Conventional Concepts.'' Obesity Surgery. 
2017;27(3):837-843.
8. Dresel, A., J.A. Kuhn, M.V. Westmoreland, et al., ``Establishing 
a Laparoscopic Gastric Bypass Program.'' American Journal of 
Surgery. 2002;184(6):617-620; discussion 620.

[[Page 17123]]

9. Jain, S., S.K. Jain, R. Kaza, et al., ``This Challenging 
Procedure has Successful Outcomes: Laparoscopic Nephrectomy in 
Inflammatory Renal Diseases.'' Urology Annals. 2018;10(1):35-40.
10. Kuthe, A., A. Haemmerle, K. Ludwig, et al., ``Multicenter 
Prospective Evaluation of a New Articulating 5-mm Endoscopic Linear 
Stapler.'' Surgical Endoscopy and Other Interventional Techniques. 
2016;30(5):1883-1893.
11. Mattioli, G., M. Castagnetti, P. Repetto, et al., 
``Complications of Mechanical Suturing in Pediatric Patients.'' 
Journal of Pediatric Surgery. 2003;38(7):1051-1054.
12. Nadu, A., Y. Mor, J. Chen, et al., ``Laparoscopic Nephrectomy: 
Initial Experience in Israel with 110 Cases.'' Israel Medical 
Association Journal. 2005;7(7):431-434.
13. Pandya, S., J.J. Murray, J.A. Coller, et al., ``Laparoscopic 
Colectomy: Indications for Conversion to Laparotomy.'' Archives of 
Surgery. 1999;134(5):471-475.
14. Simper, S.C., J.M. Erzinger, and S.C. Smith, ``Comparison of 
Laparoscopic Linear Staplers in Clinical Practice.'' Surgery for 
Obesity and Related Diseases. 2007;3(4):446-450.
15. Allen, M.S., C. Deschamps, R.E. Lee, et al., ``Video-Assisted 
Thoracoscopic Stapled Wedge Excision for Indeterminate Pulmonary 
Nodules.'' Journal of Thoracic and Cardiovascular Surgery. 
1993;106(6):1048-1052.
16. Asamura, H., K. Suzuki, H. Kondo, et al., ``Mechanical Vascular 
Division in Lung Resection.'' European Journal of Cardio-Thoracic 
Surgery: Official Journal of the European Association for Cardio-
thoracic Surgery. 2002;21(5):879-882.
17. Breda, A., J. Veale, J. Liao, et al., ``Complications of 
Laparoscopic Living Donor Nephrectomy and Their Management: The UCLA 
Experience.'' Urology. 2007;69(1):49-52.
18. Chan, D., J.T. Bishoff, L. Ratner, et al., ``Endovascular 
Gastrointestinal Stapler Device Malfunction During Laparoscopic 
Nephrectomy: Early Recognition and Management.'' Journal of Urology. 
2000;164(2):319-321.
19. Cresswell, A.B., F.K.S. Welsh, T.G. John, et al., ``Evaluation 
of Intrahepatic, Extra-Glissonian Stapling of the Right Porta 
Hepatis vs. Classical Extrahepatic Dissection During Right 
Hepatectomy.'' HPB. 2009;11(6):493-498.
20. Deng, D.Y., M.V. Meng, H.T. Nguyen, et al., ``Laparoscopic 
Linear Cutting Stapler Failure.'' Urology. 2002;60(3):415-419.
21. Gonzalez Valverde, F.M., A.S. Cifuentes, M.R, Marin, et al., 
``Frequency and Causes of Conversion from Laparoscopic to Open Roux-
en-Y Gastric Bypass for Morbid Obesity: The Experience in Our 
Service.'' Obesity Surgery. 2013;23(3):391-392.
22. Kaushik, M., A. Bagul, P.J. Yates, et al., ``Comparison of 
Techniques of Vascular Control in Laparoscopic Donor Nephrectomy: 
The Leicester Experience.'' Transplantation Proceedings. 
2006;38(10):3406-3408.
23. Kim, C.B., K.W. Suh, J.I. Moon, et al., ``Roux-en-Y End-to-Side 
Esophagojejunostomy with Stapler After Total Gastrectomy.'' Yonsei 
Medical Journal. 1993;34(4):334-339.
24. Ky, A.J., T. Sonoda, and J.W. Milsom, ``One-Stage Laparoscopic 
Restorative Proctocolectomy: An Alternative to the Conventional 
Approach?'' Diseases of the Colon and Rectum. 2002;45(2):207-211.
25. Kyzer, S. and P.H. Gordon, ``Experience with the Use of the 
Circular Stapler in Rectal Surgery.'' Diseases of the Colon and 
Rectum. 1992;35(7):696-706.
26. Liu, K.L., Y.J. Chiang, H.H. Wang, et al., ``Techniques of 
Vascular Control in Laparoscopic Donor Nephrectomy.'' 
Transplantation Proceedings. 2008;40(7):2342-2344.
27. Offodile, A.C. II, D.L. Feingold, A. Nasar, et al., ``High 
Incidence of Technical Errors Involving the EEA Circular Stapler: A 
Single Institution Experience.'' Journal of the American College of 
Surgeons. 2010;210(3):331-335.
28. Raoof, M., T.A. Aloia, J.N. Vauthey, et al., ``Morbidity and 
Mortality in 1,174 Patients Undergoing Hepatic Parenchymal 
Transection Using a Stapler Device.'' Annals of Surgical Oncology. 
2014;21(3):995-1001.
29. Rosenblatt, G.S. and M.J. Conlin, ``Clipless Management of the 
Renal Vein During Hand-Assist Laparoscopic Donor Nephrectomy.'' BMC 
Urology. 2006;6.
30. Seshadri, R.A., S.K. Thammaiah, and V. Vaidhyalingam, ``Modified 
Technique of Stapled Esophagojejunostomy Without a Purse-String 
Suture.'' Indian Journal of Surgical Oncology. 2011;2(3):189-192.
31. Szwerc, M.F., R.J. Landreneau, R.S. Santos, et al., 
``Minithoracotomy Combined with Mechanically Stapled Bronchial and 
Vascular Ligation for Anatomical Lung Resection.'' Annals of 
Thoracic Surgery. 2004;77(6):1904-1910.
32. Zhang, B., J. Ma, X. Yan, et al., ``Left Minimally Invasive 
Esophagectomy in a Patient with Synchronous Esophageal and Lung 
Cancers: Case Report.'' Medicine (Baltimore). 2018;97(2).
33. Folkesson, J., J. Nilsson, L. Pahlman, et al., ``The Circular 
Stapling Device as a Risk Factor for Anastomotic Leakage.'' 
Colorectal Disease. 2004 Jul; 6(4):275-9.
34. Ouchi, A., A. Masahiko, K. Aono, et al., ``Staple-line 
Recurrence Arising 10 Years After Functional End-to-End Anastomosis 
for Colon Cancer: A Case Report.'' Surgical Case Reports. 2015 Dec; 
1:7.
35. Hsu, T.C. and M.J. Chen, ``Presence of Colon Carcinoma Cells at 
the Resection Line May Cause Recurrence Following Stapling 
Anastomosis.'' Asian Journal of Surgery. 2018 Nov; 41(6):569-572.
36. Checkan, E. and R.L. Whelan, ``Surgical Stapling Device-Tissue 
Interactions: What Surgeons Need to Know to Improve Patient 
Outcomes.'' Medical Devices [Auckland, NZ]. 2014(7):305-318.
37. Betzold, R. and J.A. Laryea, ``Staple Line/Anastomotic 
Reinforcement and Other Adjuncts: Do They Make a Difference?'' 
Clinics in Colon and Rectal Surgery. 2014 Dec; 27(4): 156-161.
38. Brown, S.L. and E.K. Woo, ``Surgical Stapler-Associated 
Fatalities and Adverse Events Reported to the Food and Drug 
Administration.'' Journal of the American College of Surgeons. 
2004;199(3):374-380.
39. Swayze, S. and S. Rich, ``Promoting Safe Use of Medical 
Devices.'' The Online Journal of Issues in Nursing. 2011;17(1):9.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 878 be amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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

0
2. Add Sec.  878.4740 to subpart E to read as follows:


Sec.  878.4740  Surgical stapler.

    (a) Surgical stapler for external use. (1) Identification. A 
surgical stapler for external use is a specialized prescription device 
used to deliver compatible staples to skin during surgery.
    (2) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter, subject to the limitations in Sec.  878.9.
    (b) Surgical stapler for internal use. (1) Identification. A 
surgical stapler for internal use is a specialized prescription device 
used to deliver compatible staples to internal tissues during surgery 
for resection, transection, and creating anastomoses.
    (2) Classification. Class II (special controls). The special 
controls for this device are:
    (i) Performance testing must demonstrate that the stapler, when 
used with compatible staples, performs as intended under anticipated 
conditions of use. Performance testing must include the following:
    (A) Evaluation of staple formation characteristics in the maximum 
and minimum tissue thicknesses for each staple type;
    (B) Measurement of the worst-case deployment pressures on stapler 
firing force;
    (C) Measurement of staple line strength;
    (D) Confirmation of staple line integrity; and
    (E) In vivo confirmation of staple line hemostasis.

[[Page 17124]]

    (ii) Usability testing and a labeling comprehension study must 
demonstrate that the clinician can correctly select and use the device, 
as identified in the labeling, based on reading the directions for use.
    (iii) The elements of the device that may contact the patient must 
be demonstrated to be biocompatible.
    (iv) Performance data must demonstrate the sterility of the device.
    (v) Validation of cleaning and sterilization instructions must 
demonstrate that any reusable device components can be safely and 
effectively reprocessed per the recommended cleaning and sterilization 
protocol in the labeling.
    (vi) Performance data must support the shelf life of the device by 
demonstrating continued device functionality, sterility, and package 
integrity over the identified shelf life.
    (vii) Labeling of the device must include the following:
    (A) Unless data demonstrates the safety of doing so, 
contraindications must be identified regarding use of the device on 
tissues for which the risk of stapling outweighs any reasonably 
foreseeable benefit due to known complications, including the stapling 
of necrotic or ischemic tissues and tissues outside of the labeled 
limits of tissue thickness.
    (B) Unless available information demonstrates that the specific 
warnings do not apply, the labeling must provide appropriate warnings 
regarding how to avoid known hazards associated with device use 
including:
    (i) Avoidance of obstructions to the creation of the staple line 
and the unintended stapling of other anatomic structures;
    (ii) Avoidance of clamping and unclamping of delicate tissue 
structures to prevent tissue damage;
    (iii) Avoidance of use of the stapler on large blood vessels, such 
as the aorta;
    (iv) Establishing and maintaining proximal control of blood vessels 
prior to stapling;
    (v) Appropriate measures to take if a stapler malfunction occurs 
while applying staples across a blood vessel, such as clamping or 
ligating the vessel before releasing the stapler, while the stapler is 
still closed on the tissue; and
    (vi) Ensuring stapler compatibility with staples.
    (C) Specific user instructions for proper device use including 
measures associated with the prevention of device malfunction, 
evaluation of the appropriateness of the target tissue for stapling, 
and evaluation of the resultant staple line.
    (D) List of staples with which the stapler has been demonstrated to 
be compatible.
    (E) Identification of key performance parameters and technical 
characteristics of the stapler and the compatible staples needed for 
safe use of the device.
    (F) Information regarding tissues on which the stapler is intended 
to be used.
    (G) Identification of safety mechanisms of the stapler.
    (H) Validated methods and instructions for reprocessing of any 
reusable device components.
    (I) An expiration date/shelf life.
    (viii) Package labels must include critical information and 
technical characteristics necessary for proper device selection.
0
3. In Sec.  878.4800, revise paragraph (a) to read as follows:


Sec.  878.4800  Manual surgical instrument for general use.

    (a) Identification. A manual surgical instrument for general use is 
a nonpowered, hand-held, or hand-manipulated device, either reusable or 
disposable, intended to be used in various general surgical procedures. 
The device includes the applicator, clip applier, biopsy brush, manual 
dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, 
clamp, contractor, curette, cutter, dissector, elevator, skin graft 
expander, file, forceps, gouge, instrument guide, needle guide, hammer, 
hemostat, amputation hook, ligature passing and knot-tying instrument, 
knife, blood lancet, mallet, disposable or reusable aspiration and 
injection needle, disposable or reusable suturing needle, osteotome, 
pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, 
one-piece scalpel, snare, spatula, disposable or reusable stripper, 
stylet, suturing apparatus for the stomach and intestine, measuring 
tape, and calipers. A surgical instrument that has specialized uses in 
a specific medical specialty is classified in separate regulations in 
parts 868 through 892 of this chapter.
* * * * *

    Dated: April 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08260 Filed 4-23-19; 8:45 am]
BILLING CODE 4164-01-P


