[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Rules and Regulations]
[Pages 56195-56204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22041]


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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: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
issuing a final order to reclassify surgical staplers for internal use 
(formerly 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 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 issuing this reclassification on 
its own initiative based on new information. As part of this 
reclassification, FDA is also amending 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: This order is effective October 8, 2021.

FOR FURTHER INFORMATION CONTACT: George Gibeily, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4660, Silver Spring, MD 20993, 301-796-0276, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    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 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).
    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 such 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. 
U.S. 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, 366 F.2d at 181) or in light of changes in ``medical 
science'' (see Upjohn, 422 F.2d at 951). 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., Gen. Med. Co. v. FDA, 770 F.2d 214 (D.C. Cir. 
1985); Contact Lens Mfrs. Ass'n 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

[[Page 56196]]

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 has not exempted this class II 
device from premarket notification (510(k)) submission as provided 
under section 510(m) of the FD&C Act.
    On April 24, 2019 (84 FR 17116), FDA published a proposed order in 
the Federal Register to reclassify surgical staplers for internal use 
(the proposed order). FDA also proposed special controls and proposed 
amending 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. The period 
for public comment on the proposed order closed on June 24, 2019. FDA 
received and has considered comments on the proposed order, as 
discussed in section III. FDA also held a meeting of the General and 
Plastic Surgery Devices Advisory Panel (the Panel) on May 30-31, 2019, 
in accordance with section 513(b) of the FD&C Act (21 U.S.C. 360c(b)) 
(Ref. 1). In publishing the proposed order, holding the Panel meeting, 
and considering comments to the docket, FDA has met the requirements 
for reclassification under section 513(e)(1)(A)(i) of the FD&C Act.

II. Panel Meeting

A. Panel Feedback

    On May 30, 2019, the Panel met to discuss and make recommendations 
regarding the reclassification of surgical staplers for internal use 
from class I (general controls) to class II (special controls) (Ref. 
1). At the Panel meeting, FDA presented the risks, mitigations, and 
special controls identified in the proposed order.
    The Panel generally agreed that the list of risks and proposed 
mitigations proposed by FDA was accurate and agreed with FDA that the 
risk profile was consistent with class II devices. Some Panel members 
noted that adverse tissue reaction may not be a particular risk due to 
the minimal patient contact duration with body tissues. Some Panel 
members also stated that ``increased risk of cancer recurrence'' should 
be removed from the list of risks, and no Panel members disagreed with 
that position.
    The Panel generally agreed that FDA's proposed special controls are 
reasonable and sufficient to support reclassification of surgical 
staplers for internal use to class II. Some members noted that 
biocompatibility testing may not be needed as a special control due to 
the limited contact duration with tissues.
    The Panel also believed that usability testing should be required, 
but recommended revision of the term ``labeling comprehension study'' 
in the special controls, since the Panel felt that the study should 
focus on evaluation of the labeling rather than on the user. Some Panel 
members felt that certain warnings in the labeling special controls, 
such as ``establishing and maintaining proximal control of blood 
vessels prior to stapling'' and ``avoidance of use of the stapler on 
large blood vessels,'' should be removed, as they believed the labeling 
should allow the surgeon to exercise their own clinical judgement 
rather than dictating surgical practice. One Panel member additionally 
implied that the term ``large blood vessels'' is vague.
    Some Panel members believed that a registry could be helpful as 
part of the special controls, but there was a divergence of opinion on 
the need for a registry as part of device reclassification and the 
ultimate utility of the data that would likely be collected.
    The Panel also discussed unique sterility considerations regarding 
powered staplers. The Panel also discussed additional special controls 
that they believed were necessary for powered surgical staplers such as 
electrical safety and electromagnetic compatibility testing and 
software verification and validation. The Panel expressed the view that 
powered staplers should meet these requirements.
    Based upon the available scientific evidence and risks to health 
posed by surgical staplers for internal use, the Panel unanimously 
recommended the reclassification of surgical staplers for internal use 
from class I (general controls) to class II (special controls), 
agreeing with FDA's conclusion that general controls by themselves were 
insufficient to provide reasonable assurance of safety and 
effectiveness.

B. FDA Response to Panel Feedback and Changes in the Final Order

    The Panel agreed with FDA in recommending the reclassification of 
surgical staplers for internal use from class I (general controls) to 
class II (special controls). The Panel generally agreed with the risks 
to health identified by FDA and the applicable special controls 
associated with the identified risks. FDA's responses to the 
recommendations are detailed in this section. As discussed in detail in 
sections III and IV below, FDA also considered comments from industry, 
professional societies, and stakeholders in developing the special 
controls in this final order. However, here in section II, we 
specifically address the Panel recommendations and FDA's response.
1. Risks
    The Panel recommended removing increased risk of cancer recurrence 
and adverse tissue reaction from the risks to health presented at the 
Panel meeting. While surgical stapler malfunctions have resulted in 
complications such as anastomotic leaks, which have been associated 
with an increased risk of cancer recurrence, FDA agrees that there is 
limited evidence directly linking surgical stapler failure or 
malfunction with an increased risk of cancer recurrence (Refs. 2- 4). 
Therefore, due to the limited evidence directly linking surgical 
stapler failure or malfunction with an increased risk of cancer 
recurrence, FDA agrees with removing increased risk of cancer 
recurrence from the list of complications associated with device 
failure/malfunction. FDA does not agree that adverse tissue reaction 
should be removed as a risk to health, as staplers for internal use 
contain patient-contacting materials that contact internal tissues, and 
these patient-contacting device materials may pose a risk of adverse 
tissue reaction if not adequately demonstrated to be biocompatible. The 
demonstration of biocompatibility for these devices is consistent with 
our approach for other devices with similar type and duration of 
contact; therefore, FDA has not removed the applicable special control 
regarding biocompatibility (Ref. 5).
    The Panel had specifically been asked to consider additional risks 
posed by powered staplers that were not identified in the proposed 
order. The Panel noted that the risks associated with sterility are 
different for non-powered staplers, which are generally packaged 
sterile, and powered staplers, part of which must be reprocessed.

[[Page 56197]]

2. Special Controls
    The Panel discussed and provided recommendations regarding the 
biocompatibility, labeling comprehension study, labeling, and sterility 
special controls identified in the proposed order. The Panel also 
discussed the possible addition of special controls regarding use of 
registries and powered staplers.
    As discussed above in section II.B.1., FDA has not removed the 
special control regarding biocompatibility since surgical staplers for 
internal use contain patient-contacting device materials that may pose 
a risk of adverse tissue reaction if not adequately demonstrated to be 
biocompatible.
    FDA acknowledges and agrees with the Panel's recommendation that 
``labeling comprehension'' testing should focus on evaluation of the 
clarity of the labeling rather than on the user's comprehension of the 
labeling. In response to the Panel's recommendation to revise the term 
``labeling comprehension study'' in the special controls, FDA notes 
that the term ``labeling comprehension study'' is commonly used when 
referring to a study assessing the extent to which the labeling conveys 
the intended message to the user, such that the user can understand and 
apply this information when making decisions regarding device selection 
and use. However, a labeling comprehension study may not be the only 
way to assess how well the labeling results in use of the device as 
intended, therefore we are revising this special control to use the 
term ``human factors testing'' in place of ``usability testing and 
labeling comprehension study.'' FDA continues to find that such human 
factors testing is necessary to mitigate the risk of complications 
associated with use error or improper device selection and use 
specifically related to device labeling.
    Based, in part, on feedback from the Panel that the labeling should 
allow surgeons to exercise their own clinical judgement, FDA has made 
several edits to the labeling special controls. FDA has revised the 
warning regarding ``establishing and maintaining proximal control of 
blood vessels'' to state ``establishing proximal control of blood 
vessels prior to stapling where practical'' and to also include 
``methods of blood vessel control in the event of stapler failure.'' 
FDA has revised the warning regarding ``avoidance of use of the stapler 
on large blood vessels, such as the aorta'' to state ``avoidance of use 
of the stapler on the aorta.'' FDA has also removed the requirement to 
include specific user instructions for evaluation of the resultant 
staple line from the labeling special controls.
    While the Panel had a distinct discussion on the possible addition 
of registries as a special control, use of registries was not added as 
a special control due in part to the divergence of the Panel's opinion 
on the necessity for a registry as part of device reclassification. 
While FDA acknowledges that use of registries may be helpful in 
understanding the performance of these devices, FDA determines that 
mandating the use of registries is not needed to provide a reasonable 
assurance of the safety and effectiveness of surgical staplers for 
internal use.
    Finally, the Panel did not disagree with FDA's request to consider 
the inclusion of specific special controls for powered surgical 
staplers for internal use. Special controls regarding electrical 
safety, electromagnetic compatibility, software verification, 
validation, and hazard analysis for powered staplers have been added 
accordingly. While FDA acknowledges that powered staplers may have 
unique sterility considerations as discussed by the Panel, FDA notes 
that all surgical staplers, both manual and powered, must be 
demonstrated to be sterile. Therefore, the special control regarding 
sterility (``Performance data must demonstrate the sterility of the 
device'') remains unchanged.

III. Comments on the Proposed Order and FDA Response to Comments

A. Introduction

    In response to the April 24, 2019, proposed order (84 FR 17116), 
FDA received seven sets of comments to the docket for the proposed 
order (FDA-2019-N-1250), some of which contain one or more comments on 
more than one issue. In addition, FDA received two sets of public 
comments to the docket for FDA's draft guidance, ``Surgical Staplers 
and Staples for Internal Use--Labeling Recommendations'' (FDA-2019-D-
1262) that contained one or more comments regarding the proposed order. 
Collectively, these comments originated from individual consumers, 
academia, healthcare professionals, healthcare associations, and 
industry. All commenters support the proposed reclassification of 
surgical staplers for internal use, and a few expressed concerns 
regarding specific special controls, which we address in section B. 
below.
    Additionally, FDA received some comments to the docket for the 
proposed order that are regarding FDA's ``Draft Surgical Staplers and 
Staples for Internal Use--Labeling Recommendations'' guidance. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
notice of availability for the final ``Surgical Staplers and Staples 
for Internal Use--Labeling Recommendations'' guidance. These comments 
were considered in the finalization of this guidance. As discussed 
below, FDA intends for the ``Surgical Staplers and Staples for Internal 
Use--Labeling Recommendations'' guidance to provide recommendations to 
help manufacturers comply with the labeling special controls. As such, 
FDA has utilized the ``Surgical Staplers and Staples for Internal Use--
Labeling Recommendations'' guidance to provide additional 
clarification, where appropriate.
    The order of response to the commenters is purely for 
organizational purposes and does not signify the comment's value or 
importance nor the order in which comments were received. Certain 
comments are grouped together under a single number because the subject 
matter is similar.

B. Description of Comments and FDA Response

    (Comment 1) Some commenters shared their own personal experiences 
with surgical staplers for internal use, such as adverse events 
experienced during surgeries, types of malfunctions encountered with 
surgical staplers, or best practices taken to help ensure safety of 
surgical staplers. One of these commenters encouraged FDA to put into 
effect whatever additional safety measures it sees fit to make surgical 
staplers for internal use safer.
    (Response 1) FDA notes that, as discussed in the proposed order, 
malfunctions and misuse associated with surgical staplers for internal 
use have resulted in serious adverse events, including deaths. FDA 
determines that reclassifying surgical staplers for internal use from 
class I to class II, establishing special controls, and requiring 
premarket review will help ensure a reasonable assurance of safety and 
effectiveness for these devices.
    (Comment 2) One commenter requested that FDA consider establishing 
requirements to make public announcements about large scale problems 
with medical devices.
    (Response 2) Requiring public announcements about large scale 
problems with medical devices falls outside the scope of FDA's 
reclassification of surgical staplers for internal use described in 
this final order. Nonetheless, FDA routinely posts

[[Page 56198]]

Medical Device Safety Communications to describe FDA's analysis of a 
current issue or problem and provide specific regulatory approaches and 
clinical recommendations for patient management. FDA's publicly 
available Medical Device Reporting Database includes information on 
devices that may have malfunctioned or caused a death or serious 
injury. Likewise, FDA's publicly available Medical Device Recalls 
database provides information on medical device recalls. In addition, 
FDA posts consumer information about Class I and some Class II and III 
recalls on its website in order to ensure that patients are aware of 
the seriousness of the potential health hazard posed by exposure to the 
product.
    (Comment 3) Some commenters discussed the benefits of surgical 
staplers for internal use, such as decreasing operative time, reducing 
surgical variability, and enabling more complex surgical procedures. 
Some commenters stated that the risks of the device need to be 
considered against these benefits, and that the number of adverse 
events need to be considered in the context of the large number of 
surgical procedures performed using these devices.
    (Response 3) FDA agrees that surgical staplers for internal use 
offer many important benefits, and that the risks of these devices need 
to be considered against their benefits. As described in the proposed 
order, FDA set forth the proposed reclassification and a substantive 
summary of the valid scientific evidence, including the public health 
benefits of the use of the device, and the nature and incidence of the 
risks of the device. Based on our analysis of the benefits and risks 
posed by surgical staplers for internal use, FDA determines that 
general controls on their own are insufficient to provide reasonable 
assurance of safety and effectiveness. The special controls identified 
in this final order, together with general controls, are necessary to 
provide a reasonable assurance of safety and effectiveness for surgical 
staplers for internal use, and as such, class II is the more 
appropriate classification for these devices.
    (Comment 4) Similar to the Panel's feedback, some commenters felt 
that increased risk of cancer recurrence should be removed from the 
list of risks to health due to lack of evidence associating surgical 
staplers for internal use with an increased risk of cancer recurrence.
    (Response 4) As discussed above, in section II. B., while surgical 
stapler malfunctions have resulted in complications such as anastomotic 
leaks, and anastomotic leaks have been associated with an increased 
risk of cancer recurrence, FDA agrees that there is limited evidence 
directly linking surgical stapler failure/malfunction with an increased 
risk of cancer recurrence (Refs. 2-4). Therefore, FDA agrees with 
removing increased risk of cancer recurrence from the list of 
complications associated with device failure/malfunction in the risks 
to health.
    (Comment 5) Similar to the Panel's feedback, some commenters felt 
that adverse tissue reaction should be removed as a risk to health 
associated with surgical staplers for internal use, as the stapler only 
has incidental contact with the patient.
    (Response 5) As discussed above, in section II.B., FDA does not 
agree that adverse tissue reaction should be removed as a risk to 
health, as staplers for internal use contain patient-contacting 
materials that contact internal tissues, and these patient-contacting 
device materials may pose a risk of adverse tissue reaction if not 
adequately demonstrated to be biocompatible. The demonstration of 
biocompatibility for these devices is consistent with our approach for 
other devices with similar type and duration of contact, therefore the 
associated special control has also been maintained (Ref. 5).
    (Comment 6) Some commenters requested that FDA work collaboratively 
with industry and professional societies to develop the special 
controls (e.g., specific language for warnings) and to develop a 
uniform color coding system for all stapler reloads.
    (Response 6) FDA has considered extensive comments from industry, 
professional societies, and other stakeholders in developing the 
special controls in this final order. While color coding is helpful and 
FDA would support development of a uniform color coding system if it 
came from a consensus body, FDA believes that the special controls in 
this final order, together with general controls, are sufficient to 
provide a reasonable assurance of safety and effectiveness for surgical 
staplers for internal use.
    (Comment 7) One commenter stated that the special controls for 
surgical staplers for internal use should be established in accordance 
with least burdensome principles.
    (Response 7) As stated in FDA's guidance, ``The Least Burdensome 
Provisions: Concepts and Principles,'' FDA defines ``least burdensome'' 
to be the minimum amount of information necessary to adequately address 
a relevant regulatory question or issue through the most efficient 
manner at the right time (Ref. 6). FDA used the least burdensome 
approach in weighing the risks of surgical staplers for internal use 
with their benefits. FDA finds that the special controls identified in 
this final order represent the minimum amount of information necessary 
to provide a reasonable assurance of the safety and effectiveness of 
these devices.
    (Comment 8) One commenter felt that the proposed performance 
testing special controls represented a reasonable approach for 
evaluating the safety and effectiveness of surgical staplers for 
internal use, but that greater specifics regarding the standards, 
methods, and relevance of the proposed testing controls are needed to 
fully evaluate the proposed special controls.
    (Response 8) FDA agrees that the performance testing special 
controls identified in this final order are necessary to provide a 
reasonable assurance of the safety and effectiveness for these devices. 
FDA notes that the performance testing special controls are stated 
broadly to allow flexibility in different approaches in complying with 
the special controls.
    (Comment 9) Some commenters noted that firing force is an important 
parameter for manual surgical staplers for internal use, but is not 
applicable to powered surgical stapler devices.
    (Response 9) FDA agrees that firing force is an important parameter 
applicable to manual surgical staplers for internal use and is not 
applicable to powered surgical staplers. Therefore, FDA has revised the 
performance testing special controls to include measurement of the 
worst-case deployment pressures on stapler firing force specifically 
for manual staplers.
    (Comment 10) Similar to the Panel's feedback, some commenters noted 
the importance of ensuring that the product labeling and instructions 
for use do not interfere with clinical decision making and a 
physician's ability to exercise his or her professional judgement. The 
commenters noted that too much information in the product labeling can 
make the labeling difficult to read, reducing its value to physicians, 
and provided a general recommendation to make the labeling special 
controls less prescriptive.
    (Response 10) As discussed above, in section II, regarding the 
Panel's discussion of the proposed special control for a labeling 
comprehension study, FDA acknowledges the concern that too much 
information in the product labeling can make the labeling difficult to 
read, and that it is important for the labeling to be clear for the 
user. However, FDA also notes that, as

[[Page 56199]]

discussed in the proposed order, there have been a large number of 
adverse events associated with use of both surgical staplers and 
staples for internal use; both device misuse and device malfunctions 
are root causes of these adverse events. Therefore, FDA finds it is 
essential to communicate specific information about the risks, 
limitations, and directions for use in the labeling for surgical 
staplers and staples for internal use to lower the risk of occurrence 
of these adverse events and to promote safe and effective use of these 
devices.
    As discussed separately in the responses to the comments below in 
section IV, FDA has chosen to remove or revise certain labeling special 
controls in an effort to allow for physician discretion as discussed 
with the Panel, but we continue to conclude that other labeling special 
controls are necessary to provide a reasonable assurance of the safety 
and effectiveness of these devices.
    (Comment 11) Some commenters felt that the contraindication that 
the device should not be used to staple tissues that are necrotic, 
friable, or have altered integrity should be removed from the stapler 
labeling as it extends into the realm of surgical practice and involves 
the application of medical judgement that should be left to trained 
surgeons.
    (Response 11) FDA disagrees that the contraindication regarding 
stapling of tissues that are necrotic, friable, or have altered 
integrity should be removed from the labeling. FDA notes that 
application of staples to tissues that are necrotic, friable, or have 
altered integrity has resulted in complications such as, but not 
limited to, tissue damage, anastomotic leakage, bleeding, abscess, 
sepsis, peritonitis, and hemorrhage. To FDA's knowledge, there is no 
known benefit of applying surgical staples to tissues that are 
necrotic, friable, or have altered integrity. Therefore, FDA determines 
that the risk of stapling tissues that are necrotic, friable, or have 
altered integrity outweighs any reasonably foreseeable benefit due to 
known complications. FDA finds that this contraindication is necessary 
to mitigate the risks of complications associated with improper device 
use and to provide a reasonable assurance of the safety and 
effectiveness of these devices.
    (Comment 12) One commenter felt that the warning to visually 
inspect for inclusion of unintended anatomic structures within the 
staple line should be removed from the stapler labeling as it extends 
into the realm of surgical practice and involves the application of 
medical judgement that should be left to trained surgeons.
    (Response 12) FDA disagrees that the warning regarding avoidance of 
obstructions to the creation of the staple line and the unintended 
stapling of other anatomic structures should be removed from the 
labeling. As noted in the proposed order, obstructions to the creation 
of the staple line and unintended stapling of anatomic structures have 
been associated with known hazards. For example, FDA has received 
medical device reports where obstructions to the staple line and/or 
unintended stapling of anatomic structures have resulted in anastomotic 
leaks and other injuries. Therefore, FDA finds that this warning is 
necessary to mitigate the risks of complications associated with 
improper device use and to provide a reasonable assurance of the safety 
and effectiveness of these devices.
    (Comment 13) Similar to the Panel discussion, some commenters felt 
that the warning to establish and maintain adequate proximal control of 
blood vessels prior to stapling should be removed from the stapler 
labeling as it extends into the realm of surgical practice and involves 
the application of medical judgement that should be left to trained 
surgeons.
    (Response 13) FDA disagrees that the warning to establish and 
maintain adequate proximal control of blood vessels prior to stapling 
should be removed entirely, as it is important to have methods of blood 
vessel control in place in the event of stapler failure to prevent the 
risk of uncontrolled bleeding. However, FDA acknowledges there are 
situations where it may not be practical to establish proximal control 
of blood vessels prior to stapling. Therefore, FDA has revised the 
labeling special control to include a warning regarding the 
establishment of proximal control of blood vessels prior to stapling 
``where practical'' and establishment of ``methods of blood vessel 
control in place in the event of stapler failure.'' FDA finds that this 
warning is necessary to mitigate the risks of complications associated 
with improper device use and to provide a reasonable assurance of the 
safety and effectiveness of these devices.
    (Comment 14) One commenter felt that the warning that clamping and 
unclamping of delicate tissue structures, such as venous structures and 
bile ducts, may result in damage to tissue irrespective of stapler 
firing, should be removed from the stapler labeling as it extends into 
the realm of surgical practice and involves the application of medical 
judgement that should be left to trained surgeons.
    (Response 14) FDA disagrees that the warning regarding avoidance of 
clamping and unclamping of delicate tissue structures should be removed 
from the labeling. As discussed in the proposed order, clamping and 
unclamping of delicate tissue structures have been associated with 
known hazards such as tissue damage. For example, FDA has received 
medical device reports where clamping of the stapler has resulted in 
tissue damage or bleeding. As also noted in FDA's Letter to Health Care 
Providers, ``Safe Use of Surgical Staplers and Staples,'' clamping of 
staplers on delicate tissue can cause injury even if no staples are 
fired (Ref. 7). Therefore, FDA finds that this warning is necessary to 
mitigate the risks of complications associated with improper device use 
and to provide a reasonable assurance of the safety and effectiveness 
of these devices.
    (Comment 15) Some commenters felt that the warning regarding 
measures to take if a stapler malfunction occurs while applying staples 
across a blood vessel, including clamping or ligating the vessel before 
releasing the stapler, while the stapler is still closed on the tissue, 
should be removed from the stapler labeling as it extends into the 
realm of surgical practice and involves the application of medical 
judgement that should be left to trained surgeons.
    (Response 15) FDA agrees that the warning regarding ``clamping or 
ligating the vessel before releasing the stapler, while the stapler is 
still closed on the tissue'' may be too prescriptive and has removed 
this from the labeling special controls. Nonetheless, FDA continues to 
find that it is important to have methods of blood vessel control in 
place in the event of stapler failure in order to prevent the risk of 
uncontrolled bleeding. Therefore, FDA has modified the remainder of the 
labeling special controls to add a warning regarding methods of blood 
vessel control in the event of stapler failure. FDA finds that this 
warning is necessary to mitigate the risks of complications associated 
with improper device use and to provide a reasonable assurance of the 
safety and effectiveness of these devices.
    (Comment 16) Consistent with the Panel discussion, commenters 
requested revision or removal of the warning regarding ``avoidance of 
use of the stapler on large blood vessels, such as the aorta.'' Some 
commenters felt that the term ``large blood vessels'' is vague and 
recommended revising the statement to warn specifically against 
stapling the aorta. Some commenters noted that many surgical staplers 
are contraindicated for use on the aorta and felt that this statement 
should only be

[[Page 56200]]

included as a warning if it is not already included as a 
contraindication. Other commenters felt that this statement should be 
removed from the labeling, since it extends into the realm of surgical 
practice and involves the application of a surgeon's medical judgement.
    (Response 16) FDA agrees that use of the term ``large blood 
vessels'' may be subject to interpretation and has revised the special 
control to remove ``avoidance of use of the stapler on large blood 
vessels'' to leave more room for surgeon judgement, which FDA believes 
is appropriate here. Nonetheless, FDA has retained the warning 
regarding ``avoidance of use of the stapler on the aorta.'' As 
discussed at the Panel meeting, FDA has received several medical device 
reports where stapling the aorta has resulted in serious adverse 
events, such as significant blood loss. Based on a benefit risk 
analysis, as well as information received from medical device reports, 
FDA finds that the risk of stapling the aorta outweighs the risk of 
stapling other large blood vessels. Therefore, FDA finds that a warning 
regarding avoidance of use of the stapler on the aorta is necessary to 
mitigate risks of complications associated with improper device use and 
to ensure a reasonable assurance of safety and effectiveness of these 
devices.
    (Comment 17) One commenter noted that premarket testing for staple 
line integrity provides important information for assessing the safety 
and effectiveness of surgical staplers. Nonetheless, some commenters 
felt that the procedures for evaluating staple line integrity should 
not be included in the directions for use, as these procedures extend 
into the realm of surgical practice and may differ depending on 
different circumstances (e.g., patient conditions, tissue types, 
surgeon's training and experience).
    (Response 17) FDA agrees that premarket testing for staple line 
integrity provides important information for assessing the safety and 
effectiveness of surgical staplers for internal use. Therefore, 
confirmation of staple line integrity remains as a performance testing 
special control. FDA acknowledges that procedures for evaluating staple 
line integrity may differ depending on different circumstances. 
Therefore, FDA has removed the requirement to include specific user 
instructions for evaluation of the resultant staple line from the 
labeling special controls.
    (Comment 18) One commenter felt that the warning to ensure stapler 
compatibility with staples is unnecessary, since the labeling of the 
device must include a list of staples with which the stapler has been 
demonstrated to be compatible.
    (Response 18) Even with a list of compatible staples present in the 
labeling, it is possible that a user may still try to use the stapler 
with an incompatible staple if a warning to ensure stapler 
compatibility with staples is not present. Therefore, consistent with 
the proposed order, FDA continues to find that the warning to ensure 
stapler compatibility with staples is necessary to mitigate the risk of 
complications associated with improper device use and to ensure a 
reasonable assurance of safety and effectiveness of these devices.
    (Comment 19) One commenter felt that the warning to ensure 
avoidance of obstructions to the creation of the staple line should not 
be included in the labeling, since clinical circumstances exist in 
which it may be necessary or appropriate to staple across an 
obstruction, e.g., a prior staple line.
    (Response 19) As noted in response 12 above, stapling across 
obstructions have been associated with risks such as anastomotic leaks 
and other injuries. While FDA acknowledges there may be clinical 
circumstances when a surgeon may deem it necessary or appropriate to 
cross staple lines, FDA notes that additional types of obstructions 
beyond prior staple lines exist (e.g., clips, ligatures, drainage 
tubes), and that such obstructions should be avoided due to the 
associated risks. Therefore, FDA finds that the warning to ensure 
avoidance of obstructions to the creation of the staple line should be 
included in the labeling to mitigate the risk of complications 
associated with improper device use and to ensure a reasonable 
assurance of safety and effectiveness of these devices. As noted below, 
FDA has additionally revised the special controls to include a labeling 
requirement for a warning regarding risks of crossing staple lines in 
response to a comment recommending the addition of such a warning in 
the docket for FDA's draft guidance, ``Surgical Staplers and Staples 
for Internal Use--Labeling Recommendations'' (FDA-2019-D-1262).
    (Comment 20) One commenter noted that premarket testing for staple 
line strength provides important information for assessing the safety 
and effectiveness of surgical staplers. Nonetheless, some commenters 
noted that there are no standardized test methods for evaluating staple 
line strength (e.g., burst strength). These commenters felt that staple 
line strength (e.g., burst strength) should not be included in the 
device labeling until standardized testing methodology is developed.
    (Response 20) FDA agrees that premarket testing for staple line 
strength provides important information for assessing the safety and 
effectiveness of surgical staplers for internal use. Therefore, 
measurement of staple line strength remains as a performance testing 
special control.
    For the reasons discussed in the proposed order, FDA finds that the 
labeling must include identification of key performance parameters and 
technical characteristics of the stapler and compatible staples needed 
for safe use of the device. The commenters' recommendations regarding 
removing staple line strength from product labeling due to lack of 
standardized methodology were considered in the finalization of FDA's 
``Surgical Staplers and Staples for Internal Use--Labeling 
Recommendations'' guidance, which provides FDA's recommendations 
regarding key performance parameters and technical characteristics that 
should be included in the labeling for surgical staplers. At this time, 
due to the lack of standardized testing methodology for evaluating 
staple line strength, FDA revised the final guidance to remove staple 
line strength from the list of recommendations for labeling of key 
technical characteristics and performance parameters.
    (Comment 21) One commenter noted that premarket testing for staple 
formation provides important information for assessing the safety and 
effectiveness of surgical staplers. Nonetheless, some commenters noted 
that there are no standardized test methods for evaluating the 
percentage of properly formed staples at the maximum and minimum tissue 
thickness. These commenters felt that percentage of properly formed 
staples at the maximum and minimum tissue thickness should not be 
included in the device labeling until standardized testing methodology 
is developed.
    (Response 21) FDA agrees that premarket testing for staple 
formation provides important information for assessing the safety and 
effectiveness of surgical staplers for internal use. Therefore, 
evaluation of staple formation characteristics in the maximum and 
minimum tissue thicknesses for each staple type remains as a 
performance testing special control.
    In addition, FDA finds that the labeling must include 
identification of key performance parameters and technical 
characteristics of the stapler and compatible staples needed for safe 
use of the device. FDA's ``Surgical Staplers and Staples for Internal 
Use--

[[Page 56201]]

Labeling Recommendations'' Guidance provides FDA's recommendations 
regarding key performance parameters and technical characteristics to 
include in the labeling for surgical staplers. The commenters' 
recommendations regarding percentage of properly formed staples were 
considered in the finalization of the guidance. Specifically, 
``percentage of properly formed staples at the maximum and minimum 
tissue thickness'' was removed from the list of recommended key 
performance parameters and technical characteristics due to the lack of 
standardized test methodology for evaluating these parameters.
    (Comment 22) One commenter asked FDA to clarify what is meant by 
``safety mechanisms'' for surgical staplers for internal use.
    (Response 22) FDA has provided examples and clarification for what 
is meant by ``safety mechanisms'' for surgical staplers for internal 
use in FDA's ``Surgical Staplers and Staples for Internal Use--Labeling 
Recommendations'' guidance. Specifically, the final guidance states 
that safety mechanisms include ``e.g., identification of whether a 
stapler has built-in methods for assessing and/or limiting operation 
when the underlying tissues are outside of a predefined range.'' 
``Lock-out'' and ``color firing zone'' are two examples of safety 
mechanisms for surgical staplers for internal use provided in the 
guidance.
    (Comment 23) One commenter asked FDA to revise the labeling special 
control regarding inclusion of specific user instructions for 
``evaluation of the appropriateness of the target tissue for stapling'' 
to include examples of procedures that may be used for determining that 
a tissue is appropriate for stapling, and to provide clarification for 
the types of target tissue. Another commenter requested that FDA remove 
this special control altogether, as it extends into the realm of 
surgical practice and involves the application of medical judgement 
that should be left to trained surgeons.
    (Response 23) FDA does not agree that this special control should 
be removed, as FDA believes instructions for ``evaluation of the 
appropriateness of the target tissue for stapling'' are important to 
include within specific user instructions to reduce the risk of 
complications associated with improper device use. FDA has not included 
examples of procedures that may be used for determining that a tissue 
is appropriate for stapling or examples of types of tissue, since the 
examples of procedures and tissue types may vary depending on the 
design and intended use the stapler. Instead, manufacturers should 
identify appropriate procedures and tissue types based on the design 
and intended use of their own specific stapler.
    (Comment 24) Some commenters requested that FDA clarify 
expectations for the evaluation of marketed surgical stapler products 
that were previously cleared. Some commenters felt that the special 
controls should not be retroactively applied to devices that already 
have been 510(k) cleared and have an established safety profile. Other 
commenters felt that FDA should evaluate previously cleared devices to 
determine if the devices and information contained in the previously 
cleared submissions meet the new special controls.
    (Response 24) FDA finds that all surgical staplers for internal 
use, including previously cleared devices and new devices, must comply 
with the special controls identified in this final order to ensure a 
reasonable assurance of safety and effectiveness for these devices. 
Manufacturers should refer to section V (Implementation Strategy) of 
this final order for information on dates when FDA intends to enforce 
compliance with the final order. It is the manufacturer's 
responsibility to ensure compliance with applicable laws and 
regulations administered by FDA. Manufacturers should refer to FDA's 
guidance, ``Deciding When to Submit a 510(k) for a Change to an 
Existing Device'' (Ref. 8) to determine whether a new 510(k) is 
required for changes to an existing device.

IV. Changes in the Final Order

    FDA is adopting the majority of our findings under section 513(e) 
of the FD&C Act, as published in the preamble to the proposed order (84 
FR 17116). For the reasons described previously in sections II and III, 
FDA has made revisions in this final order in response to feedback from 
the Panel and comments regarding the proposed order that were submitted 
to public dockets.
    Based, in part, on the Panel feedback and comments to the proposed 
reclassification order, FDA is issuing the following revised list of 
risks and Risks to Health and Risk Mitigation Table (table 1). The list 
reflects the addition of risks specific to powered staplers and the 
removal of ``increased risk of cancer recurrence'' as a risk:
     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, and death. Additionally, for powered staplers, 
faulty hardware or software may cause electrical hazards or 
electromagnetic interference with other devices, such as the risk of 
interference with operating monitors, misfiring or locking of the 
stapler.
     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.

 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; Labeling;
 failure/malfunction.                     and for powered staplers only:
                                         Electrical, thermal, and
                                          mechanical safety testing;
                                          Electromagnetic compatibility
                                          testing; Software validation,
                                          verification, and hazard
                                          analysis.

[[Page 56202]]

 
Complications associated with use error/ Human Factors testing and
 improper device selection and use.       Labeling.
Adverse Tissue Reaction................  Biocompatibility evaluation.
Infection..............................  Labeling, Sterility testing,
                                          and Shelf-Life Testing.
------------------------------------------------------------------------

    FDA modified the special controls to provide additional specificity 
regarding manual and powered staplers, where appropriate. Specifically, 
FDA modified the performance testing special controls to include 
clarification that measurement of worst-case deployment pressures on 
stapler firing force is applicable only to manual staplers (see Sec.  
878.4740(b)(2)(i)(B)). FDA added special controls for powered staplers 
regarding electrical safety, electromagnetic compatibility, software 
verification, validation, and hazard analysis (see Sec.  
878.4740(b)(2)(ii) and (b)(2)(iii)).
    FDA also modified the special controls to refine certain labeling 
requirements. Specifically, FDA modified the requirement for a warning 
regarding ``establishing and maintaining proximal control of blood 
vessels prior to stapling'' to ``Establishing proximal control of blood 
vessels prior to stapling where practical'' (see Sec.  
878.4740(b)(2)(ix)(B)(v)). FDA replaced the requirement for a warning 
regarding ``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'' with the requirement for a warning 
regarding ``methods of blood vessel control in the event of stapler 
failure.'' (see Sec.  878.4740(b)(2)(ix)(B)(v)). These edits were made 
for the reasons described above, including feedback from the Panel and 
commenters regarding instances where labeling should provide 
flexibility for a physician to exercise his or her professional 
judgement. FDA modified the requirement for a warning regarding 
``avoidance of use of the stapler on large blood vessels, such as the 
aorta'' to a warning regarding ``avoidance of use of the stapler on the 
aorta'' (see Sec.  878.4740(b)(2)(ix)(B)(iv)) in response to comments 
that use of the term ``large blood vessels'' is vague. FDA has also 
revised the special controls to remove the requirement for specific 
user instructions associated with ``evaluation of the resultant staple 
line'' (see Sec.  878.4740(b)(2)(ix)(C)) in response to comments that 
procedures for evaluating staple line integrity may differ depending on 
different circumstances.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice of availability for the final guidance, ``Surgical Staplers 
and Staples for Internal Use--Labeling Recommendations.'' FDA made 
additional revisions in this final order to reflect changes made during 
finalization of the guidance based on the feedback specifically on that 
document to the guidance docket. Specifically, FDA revised the special 
controls to include a labeling requirement for a warning regarding the 
risks of crossing staple lines (see Sec.  878.4740(b)(2)(ix)(B)(vii)) 
in response to a comment recommending the addition of such a warning to 
the guidance. FDA notes that a risk of increased leak rates when staple 
lines are crossed has been commonly reported in the medical literature 
(Refs. 9 and 10). Therefore, FDA finds that this warning is necessary 
to mitigate the risks of complications associated with improper device 
use and to provide a reasonable assurance of the safety and 
effectiveness of these devices.
    In response to a comment recommending removal of the 
contraindication for stapling of ``tissues outside the labeled limits 
of tissue thickness'' from the guidance, FDA revised the special 
controls to change this contraindication to a warning (see Sec.  
878.4740(b)(2)(ix)(B)(i)). FDA has changed the contraindication 
regarding stapling ``tissues outside the labeled limits for maximum and 
minimum tissue thickness'' to a warning instead of a contraindication 
so as not to impinge on surgeon judgement and since there is currently 
no standardized mechanism to accurately measure tissue thickness 
intraoperatively. Nonetheless, FDA notes that stapling of tissues 
outside labeled limits has been associated with serious adverse events, 
such as anastomotic leakage and bleeding, in medical device reports. 
Therefore, FDA finds that a warning regarding stapling tissues outside 
labeled limits is necessary to mitigate the risks of complications 
associated with improper device use and to provide a reasonable 
assurance of the safety and effectiveness of these devices.
    FDA also modified the contraindication regarding ``stapling of 
necrotic or ischemic tissues'' to ``stapling of tissues that are 
necrotic, friable, or have altered integrity'' to promote consistency 
with the language used in the guidance (see Sec.  
878.4740(b)(2)(ix)(A)). FDA notes that ``necrotic or ischemic tissues'' 
are a subset of ``tissues that are necrotic, friable, or have altered 
integrity.'' As explained above, FDA has determined that the risk of 
stapling tissues that are necrotic, friable, or have altered integrity 
outweighs any reasonably foreseeable benefit due to known 
complications.
    FDA is issuing this final order revising Sec.  878.4800 by removing 
the classification of surgical staplers and codifying surgical staplers 
in the new 21 CFR 878.4740, under which surgical staplers for internal 
use is classified into class II with special controls and surgical 
staplers for external use remain in class I, exempt from premarket 
notification. In this final order, we have identified the special 
controls under section 513(a)(1)(B) of the FD&C Act that, together with 
general controls, provide a reasonable assurance of the safety and 
effectiveness for surgical staplers for internal use.\1\
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA may exempt a class II device from the premarket notification 
requirements, under section 510(m) 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 devices. FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of safety and effectiveness of surgical staplers 
for internal use, and therefore, this device type is not exempt from 
premarket notification requirements.
    The device is assigned the generic name surgical stapler for 
internal use,

[[Page 56203]]

and it is identified as a specialized prescription device used to 
deliver compatible staples to internal tissues during surgery for 
resection, transection, and creating anastomoses.

V. Implementation Strategy

    The order is 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 authorities and 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 authorities and 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 notes 
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.

VI. Analysis of Environmental Impact

    We have 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 administrative order establishes special controls that refer 
to previously approved collections of information found in other FDA 
regulations and guidance. Those collections of information are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; 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) 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 
final order, we are revising 21 CFR 878.4800 to remove the 
classification of surgical staplers and codifying 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, exempt from premarket notification.

IX. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-
402-7500; and are available for viewing by interested persons between 9 
a.m. and 4 p.m., Monday through Friday; they also are available 
electronically at https://www.regulations.gov. References without 
asterisks are not on public display at https://www.regulations.gov 
because they have copyright restriction. Some may be available at the 
website address, if listed. References without asterisks are available 
for viewing only at the Dockets Management Staff. 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, May 30, 2019, Meeting of the General and Plastic Surgery 
Devices Panel Meeting Materials (available at https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-30-31-2019-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee-meeting).
2. Folkesson, J., J. Nilsson, L. P[aring]hlman, et al., ``The 
Circular Stapling Device as a Risk Factor for Anastomotic Leakage.'' 
Colorectal Disease. 2004 July; 6(4):275-9.
3. 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 December; 1:7.
4. 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 November; 41(6):569-
572.
*5. ``Guidance for Industry and Food and Drug Administration Staff: 
Use of International Standard ISO 10993-1, `Biological Evaluation of 
Medical Devices--Part 1: Evaluation and Testing Within a Risk 
Management Process,' '' September 4, 2020, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and.
*6. ``Guidance for Industry and FDA Staff: The Least Burdensome 
Provisions: Concept and Principles,'' February 5, 2019, available 
at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles.
*7. FDA, March 8, 2019, Letter to Health Care Providers, ``Safe Use 
of Surgical Staplers and Staples,'' available at: https://www.fda.gov/medical-devices/letters-health-care-providers/safe-use-surgical-staplers-and-staples-letter-health-care-providers.
*8. ``Guidance for Industry and Food and Drug Administration Staff: 
Deciding When to Submit a 510(k) for a Change to an Existing 
Device,'' October 25, 2017, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.
9. Lee, S., B. Ahn, and S. Lee, ``The Relationship Between the 
Number of Intersections of Staple Lines and Anastomotic Leakage 
After the Use of a Double Stapling Technique in Laparoscopic 
Colorectal Surgery.'' Surgical Laparoscopy, Endoscopy & Percutaneous 
Techniques. 2017 August; 27(4):273-281.
10. Crafa, F., J. Megevand, G. Romano, and P. Sileri, ``New Double-
Stapled

[[Page 56204]]

Anastomotic Technique to Avoid Crossing Staple Lines.'' Techniques 
in Coloproctology. 2015; 19: 319-320.

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, 21 CFR 
part 878 is 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) For manual staplers only, 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.
    (ii) For powered staplers only, appropriate analysis/testing must 
demonstrate the electromagnetic compatibility and electrical, thermal, 
and mechanical safety of the device.
    (iii) For powered staplers only, appropriate software verification, 
validation, and hazard analysis must be performed.
    (iv) Human factors testing must demonstrate that the clinician can 
correctly select and safely use the device, as identified in the 
labeling, based on reading the directions for use.
    (v) The elements of the device that may contact the patient must be 
demonstrated to be biocompatible.
    (vi) Performance data must demonstrate the sterility of the device.
    (vii) 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.
    (viii) Performance data must support the shelf life of the device 
by demonstrating continued device functionality, sterility, and package 
integrity over the identified shelf life.
    (ix) 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 tissues that are necrotic, friable, or have altered integrity.
    (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:
    (1) Avoidance of use of the stapler to staple tissue outside of the 
labeled limits for maximum and minimum tissue thickness;
    (2) Avoidance of obstructions to the creation of the staple line 
and the unintended stapling of other anatomic structures;
    (3) Avoidance of clamping and unclamping of delicate tissue 
structures to prevent tissue damage;
    (4) Avoidance of use of the stapler on the aorta;
    (5) Establishing proximal control of blood vessels prior to 
stapling where practical and methods of blood vessel control in the 
event of stapler failure;
    (6) Ensuring stapler compatibility with staples; and
    (7) Risks specifically associated with the crossing of staple 
lines.
    (C) Specific user instructions for proper device use including 
measures associated with the prevention of device malfunction, and 
evaluation of the appropriateness of the target tissue for stapling.
    (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.
    (x) 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: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22041 Filed 10-7-21; 8:45 am]
BILLING CODE 4164-01-P