[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Rules and Regulations]
[Pages 66180-66189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2016-N-0400]


Medical Devices; General and Plastic Surgery Devices; 
Reclassification of Blood Lancets

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (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 three types of blood lancets used 
to puncture skin to obtain a drop of blood for diagnostic purposes from 
class I (general controls) exempt from premarket notification into 
class II (special controls) and subject to premarket notification, 
specifically, single use only blood lancets with an integral sharps 
injury prevention feature, single use only blood lancets without an 
integral sharps injury prevention feature, and multiple use blood 
lancets for single patient use only. FDA is designating special 
controls for these three types of blood lancets based on the 
determination that general controls only are not sufficient and there 
is sufficient information to establish special controls to provide a 
reasonable assurance of their safety and effectiveness. FDA is also 
reclassifying a fourth type of blood lancet, multiple use blood lancets 
for multiple patient use, from class I (general controls) exempt from 
premarket notification into class III (premarket approval). FDA is 
reclassifying these four types of blood lancets on its own initiative 
based on new information.

DATES: This order is effective November 22, 2021. See further 
discussion in section VI, Implementation Strategy.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, 
Silver Spring, MD 20993, 301-796-6527, [email protected]; or 
Stephen Ripley, Center for Biologics Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Table of Abbreviations/Commonly Used Acronyms in This Document
II. Background
    A. Classification
    B. Reclassification
    C. Requirement for Premarket Approval
III. Public Comments in Response to the Proposed Order
IV. The Final Order
V. Premarket Notification Requirement for Single Patient Use Only 
Blood Lancets
VI. Implementation Strategy
VII. Codification of Orders
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. References

I. Table of Abbreviations/Commonly Used Acronyms in This Document

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       Abbreviation or acronym                   What it means
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510(k)...............................  Premarket Notification.
515(b) Proposed Order................  Proposed Order calling for
                                        premarket approval applications
                                        for class III blood lancets
                                        published on March 3, 2016 (81
                                        FR 11151).
513(e) Proposed Order................  Proposed Order to reclassify
                                        blood lancets published on March
                                        3, 2016 (81 FR 11140).
Agency...............................  Food and Drug Administration.
CDC..................................  Centers for Disease Control and
                                        Prevention.
CFR..................................  Code of Federal Regulations.
EPA..................................  Environmental Protection Agency.
FDA..................................  Food and Drug Administration.
FDASIA...............................  Food and Drug Administration
                                        Safety and Innovation Act.
FD&C Act.............................  Federal Food, Drug, and Cosmetic
                                        Act.
FR...................................  Federal Register.
HIV..................................  Human Immunodeficiency Virus.
OMB..................................  Office of Management and Budget.
Panel................................  General & Plastic Surgery Devices
                                        Panel of the Medical Devices
                                        Advisory Committee, device
                                        classification panel on June 26,
                                        2013.
PDP..................................  Product Development Protocol.
PMA..................................  Premarket Approval Application.
PRA..................................  Paperwork Reduction Act of 1995.
PT/INR...............................  Prothrombin Time and
                                        International Normalized Ratio.
Ref..................................  Reference.
UDI..................................  Unique Device Identifier.
UPC..................................  Universal Product Code.
U.S.C................................  United States Code.
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[[Page 66181]]

II. Background

A. Classification

    The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 
et seq.), as amended, established a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of 
devices, reflecting the regulatory controls needed to provide 
reasonable assurance of their safety and effectiveness. The three 
categories of devices are class I (general controls), class II (special 
controls), and class III (premarket approval).
    Under section 513(d) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments on 
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.

B. Reclassification

    Section 513(e)(1) of the FD&C Act sets forth the process for 
issuing a final order for reclassifying a device. Specifically, prior 
to the issuance of a final order reclassifying a device, the following 
must occur: (1) Publication of a proposed order in the Federal 
Register; (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.
    FDA published a proposed order in the Federal Register of March 3, 
2016 (81 FR 11140), held a device classification panel meeting of the 
General & Plastic Surgery Devices Panel of the Medical Devices Advisory 
Committee, on June 26, 2013 (the Panel), as described in section 513(b) 
of the FD&C Act with respect to the four different types of blood 
lancet devices, and considered comments from public dockets. Therefore, 
FDA has met the requirements under section 513(e)(1) of the FD&C Act.

C. Requirement for Premarket Approval

    Elsewhere in this issue of the Federal Register, FDA has published 
a final order requiring the filing of a premarket approval application 
(PMA) or notice of completion of a product development protocol (PDP) 
for multiple patient blood lancets (class III). In practice, the option 
of filing a notice of completion of a PDP has rarely been used by 
manufacturers. For simplicity, while corresponding requirements for 
PDPs remain available to manufacturers in response to a final order 
under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)), this document 
will refer only to the requirement for the filing and obtaining 
approval of a PMA.

III. Public Comments in Response to the Proposed Order

    In the Federal Register of March 3, 2016, FDA published a proposed 
order to reclassify single patient use blood lancets from class I 
(general controls) exempt from premarket notification to class II 
(special controls) and to reclassify multiple patient blood lancets 
from class I (general controls) exempt from premarket notification to 
class III (premarket approval) (513(e) Proposed Order, 81 FR 11140)). 
On that same date, FDA also published a proposed order to require the 
filing of a PMA for multiple patient blood lancets (515(b) Proposed 
Order) (81 FR 11151). The proposed orders also stated that FDA proposed 
to amend 21 CFR part 878 to create a separate regulation under Sec.  
878.4850 (21 CFR 878.4850) for all blood lancet types (previously 
identified with product codes FMK or JCA). The comment periods for both 
proposed orders closed on June 1, 2016.
    The March 3, 2016, 513(e) Proposed Order received approximately 150 
comments from industry, professional societies, trade organizations, 
and individual consumers by the close of the comment period. Certain 
comments have been grouped together under a single comment since the 
theme of the comments are similar in nature. The grouped comments and 
FDA's response to each grouping are summarized in this section. The 
number assigned to each comment is purely for organizational purposes 
and does not signify the comment's value, importance, or the order in 
which it was received.
    As previously set forth in the 513(e) Proposed Order, FDA 
identified the following four subsets of blood lancet devices:
    1. A single use only blood lancet with an integral sharps injury 
prevention feature is a disposable blood lancet intended for a single 
use that is comprised of a single use blade attached to a solid, non-
reusable base (including an integral sharps injury prevention feature) 
that is used to puncture the skin to obtain a drop of blood for 
diagnostic purposes. The integral sharps injury prevention feature 
allows the device to be used once and then renders it inoperable and 
incapable of further use (``subset 1'');
    2. A single use only blood lancet without an integral sharps injury 
prevention feature is a disposable blood lancet intended for a single 
use that is comprised of a single use blade attached to a solid, non-
reusable base that is used to puncture the skin to obtain a drop of 
blood for diagnostic purposes (``subset 2'');
    3. A multiple use blood lancet for single patient use only is a 
multiple use capable blood lancet intended for use on a single patient 
that is comprised of a single use blade attached to a solid, reusable 
base that is used to puncture the skin to obtain a drop of blood for 
diagnostic purposes (``subset 3''); and
    4. A multiple use blood lancet for multiple patient use is a 
multiple use capable blood lancet intended for use on multiple patients 
that is comprised of a single use blade attached to a solid, reusable 
base that is used to puncture the skin to obtain a drop of blood for 
diagnostic purposes (``subset 4'').
    (Comment 1) Several comments generally agreed with the proposed 
reclassification of all four types of blood lancet devices. Some 
comments supported the proposed precautions and labeling special 
controls as necessary for healthcare providers and users of single 
patient use blood lancets. Other comments agreed that the risks to 
public health associated with use of multiple use blood lancets for 
multiple patients are sufficiently significant for FDA to reclassify 
this device type into class III (premarket approval).
    (Response 1) After considering the Panel's recommendations and 
examination of scientific information (Ref. 1, and previously described 
in the 513(e) Proposed Order (81 FR 11140 at 11142), FDA continues to 
believe that there is sufficient evidence to establish special controls 
that, together with general controls, provide a reasonable assurance of 
safety and effectiveness to reclassify single patient use only blood 
lancets to class II, as initially specified in the 513(e) Proposed 
Order. Further, FDA continues to believe that blood lancets for 
multiple patient use present a potential for unreasonable risk of 
illness or injury, that insufficient information exists for FDA to 
determine that special controls would provide a reasonable assurance of 
safety and effectiveness of the device, and that blood lancets for 
multiple patient use should be reclassified into class III.
    (Comment 2) Several comments stated that the evidence for a risk of 
infection was associated with the use of blood lancets in a 
professional care setting and therefore there was no evidence to

[[Page 66182]]

support reclassification of personal blood lancet devices in home use 
environments.
    (Response 2) FDA disagrees with the comments that there is no 
evidence to support the reclassification of single patient use blood 
lancets for home use from class I (general controls) to class II 
(special controls). At the Panel meeting on June 26, 2013, FDA 
presented an analysis of the risks to health associated with the use of 
blood lancets and new scientific data supporting these risks (Ref. 2). 
Although the information on infection transmission was generated in 
healthcare settings, FDA believes the risks to health are general risks 
that apply to all single use patient blood lancets, regardless of the 
environment in which they are used. Based on the scientific evidence 
available to the Agency at that time, blood may be transmitted between 
patient and care givers by the misuse of ``single use only'' medical 
devices that are not intended for or labeled for reuse, because they 
are not designed to be cleaned or sterilized to become safe for reuse, 
such as needles or syringes (Ref. 2). Similarly, transmission may also 
occur if validated cleaning and disinfection instructions are not 
identified and followed for multiple use blood lancets for single 
patient use only (subset 3). After reviewing the new scientific data 
supporting the identified risks to health, the Panel recommended that 
reclassifying single patient use blood lancets from class I (general 
controls) to class II (special controls) will provide a reasonable 
assurance of the safety and effectiveness of blood lancets for single 
patient use.
    The Panel also acknowledged that many of the adverse event reports 
of device problems indicate that accidental sticks are most likely when 
safety features malfunction, the lancet is difficult to remove, or when 
lancets are too dull to pierce the skin or too long to fit within the 
safety caps (Ref. 2). From January 1, 2015, to May 31, 2021, FDA 
received over 3,100 reports for blood lancets, most of which are device 
malfunctions. The most commonly reported problems include accidental 
blade sticks, the blade breaking off or remaining in a patient's 
finger, and the blade protruding from the device cap or not retracting. 
In addition, FDA received numerous reports of device malfunctioning and 
retraction problems with the blood lancets.
    FDA agrees with the Panel that reclassification from class I to 
class II is appropriate for single patient use blood lancets and is 
supported by FDA's findings reported in the 513(e) Proposed Order, 
adverse event reporting, and the panel executive summary (Ref. 2). FDA 
also agrees with the Panel that premarket notification (510(k)) 
submissions are necessary for single patient use blood lancets to 
ensure adequacy of the labeling concerning the limitation to single 
patient use only, effective sharps injury prevention features that 
disable the lancet from further use (when applicable), and blade 
dispense release mechanisms on multiple use blood lancets for single 
patient use only, as well as instructions for a safe blade disposal and 
cleaning and disinfection for the multiple use blood lancets for single 
patient use only. These special controls are consistent with the 
special controls applicable to other similar device technology such as 
injection needles (Ref. 2). As a result, FDA believes the premarket 
notification requirement and the established special controls are 
necessary to provide a reasonable assurance of safety and effectiveness 
for all for single patient use blood lancets, whether they are used in 
a home environment or a healthcare setting.
    (Comment 3) Several comments stated that the 513(e) Proposed Order, 
if finalized, would increase the cost of blood lancets for single 
patient use, putting an undue burden on patients, and would cause what 
one comment referred to as ``economic driven disruption . . . with 
lancet access driving use of less expensive devices'' in the wrong 
setting.
    (Response 3) FDA appreciates the economic concerns raised by users 
of blood lancets regarding the cost of this device; however, 
reclassification decisions are based on the level of controls necessary 
to ensure that reasonable assurance of safety and effectiveness 
requirements under 21 CFR 860.7(d) and (e) as well as section 513(e) of 
the FD&C Act are met. The regulatory requirements for blood lancets 
established by FDA are based on the probable benefits to health for the 
indications for use of blood lancet devices and the risk of the devices 
when used as intended, and not the costs of the device. FDA also agrees 
with the findings of the Panel and believes that to mitigate the known 
risks to health posed by these devices, the proposed special controls 
are necessary for single patient use only blood lancets, regardless of 
their environment of use. In addition, FDA believes that manufacturers 
of single patient use only blood lancets may already be complying with 
some of the proposed special controls (e.g., biocompatibility testing 
and package integrity testing) because they are industry standard type 
tests (Ref. 2). Therefore, FDA does not believe the reclassification of 
single patient use only blood lancets (subsets 1, 2, or 3) will result 
in an economic disruption that will affect the availability of or 
patient access to these devices for these intended purposes.
    (Comment 4) Several comments stated that the proposed special 
controls related to the disinfection of skin and/or reusable device 
components for single patient use blood lancets (subsets 1, 2, or 3), 
along with the associated special controls concerning labeling and 
validation, were either too burdensome or not appropriate. For example, 
one comment did not understand why disinfection was needed for a single 
patient home use device; a similar comment felt that cleaning and 
disinfection validation was overly burdensome for single patient home 
use devices. A few comments stated that disinfection of the skin would 
adversely affect blood glucose monitoring by resulting in 
vasoconstriction. Also, one comment suggested that FDA should not 
mandate usage of Environmental Protection Agency (EPA) commercially 
registered disinfectant if a commonly available generic disinfectant 
agent is equally effective for home use.
    (Response 4) FDA believes that the special controls related to the 
disinfection of reusable device components, along with the associated 
special controls pertaining to labeling and validation, are appropriate 
to ensure a reasonable assurance of safety and effectiveness for 
multiple use blood lancets for single patient use (i.e., subset 3). To 
reduce the risk of infection, FDA believes that reusable components of 
single patient use lancets, such as reusable bases, should be 
adequately cleaned and disinfected (i.e., reprocessed) between uses. 
Without adequate reprocessing validation conducted initially by the 
manufacturer for multiple use blood lancets for single patient use 
under simulated use conditions, it is unclear whether adequate labeling 
for cleaning and disinfection between uses by the end user can be 
developed. Further, patient soil (e.g., skin cells, oil, dirt, skin 
flora, and body fluids such as blood and sweat) can accumulate on the 
reusable component over time, creating an ideal environment for 
microbial growth. Although the lancet may be for single patient use, 
soil can become transferred from the reusable base component to the 
single-use lancet, thereby posing a risk of infection upon reuse of the 
device in the same patient.
    At the Panel meeting, FDA presented an analysis of the risks to 
health associated with the use of blood lancets and new scientific data 
supporting these

[[Page 66183]]

risks. Beyond mitigating the risk of infection, the Panel felt that 
reprocessing validation was necessary to demonstrate the functionality 
of the device over its lifetime, since the device could degrade when 
subjected to multiple cleaning and disinfection cycles (Ref. 2). FDA's 
guidance entitled ``Reprocessing Medical Devices in Health Care 
Settings: Validation Methods and Labeling'' provides recommendations 
for validation methods and labeling for proper cleaning of reusable 
medical devices that are consistent with the special controls in this 
final order (Ref. 3). Furthermore, the special controls for proper 
cleaning and disinfection of reusable components in this final order 
are also consistent with the recommendations in FDA's guidances ``Self-
Monitoring Blood Glucose Test Systems for Over-the-Counter Use'' and 
``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care 
Use,'' which concern devices that are used by some of the same patient 
populations as those using blood lancets, both in a home use and 
clinical environment (Refs. 1 and 4).
    FDA continues to believe that use of EPA-registered disinfectants 
is necessary for cleaning and disinfection of the multiple use blood 
lancets for single patient use even for home use settings. FDA 
recommends utilizing disinfectants that are effective against 
bloodborne pathogens, such as Human Immunodeficiency Virus (HIV), 
Hepatitis B, and Hepatitis C viruses. FDA also recommends the use of 
EPA-registered disinfectants because they have been demonstrated to be 
effective against specific bloodborne pathogens when used for specified 
contact times. EPA-registered disinfectants, which include both 
commercially registered disinfectants and commonly available generic 
disinfectant agents, are not allowed to make efficacy claims against 
specific pathogens unless the EPA has reviewed data to support those 
claims.
    FDA notes that preparation of skin is part of standard patient care 
prior to drawing blood from patients, and that current guidelines and 
standards (Refs. 5 and 6) generally include cleaning and disinfection 
of skin prior to capillary blood sampling. The purpose of this skin 
preparation step is to prevent infections caused by entry of microbial 
flora on the patient's skin into the puncture wound created by the 
blood lancet. Nonetheless, FDA recognizes that the skin preparation 
procedure may differ depending on the particular application and/or 
clinical use, and that specific guidelines may exist for skin 
preparation for certain clinical applications. As such, FDA has revised 
the special control regarding ``instructions on cleaning and 
disinfection of the skin to be pierced'' to instead state 
``instructions on preparation (e.g., cleaning, disinfection) of the 
skin to be pierced.''
    As a result of the available scientific information, FDA has 
determined that labeling special controls are necessary to address 
safety risks associated with use as labeled, and possible misuse, of 
blood lancets. In particular, it is critical to have specific required 
labeling special controls related to the preparation of skin and 
reprocessing of blood lancets for single patient use devices to provide 
a reasonable assurance of safety and effectiveness.
    (Comment 5) Several comments stated that the proposed labeling for 
single patient use only blood lancet devices is inadequate, overly 
prescriptive, and/or unnecessary for blood lancets used in home use 
environments.
    (Response 5) FDA continues to believe that the labeling proposed as 
special controls for single patient use only blood lancets (subsets 1, 
2, and 3) are necessary to provide a reasonable assurance of safety and 
effectiveness for these devices and believes the current labeling for 
blood lancets is inadequate. At the Panel meeting, FDA presented an 
analysis of the risks to health associated with the use of blood 
lancets and new scientific data supporting these risks. In the data 
that was presented, it was shown that the risk of bloodborne pathogen 
transmission was related to the improper use of blood lancets. FDA 
believes that additional labeling is needed to address this safety risk 
associated with misuse of blood lancets, including detailed 
descriptions of the proper use of the device and any sharps injury 
prevention feature, hand washing instructions for the user before and 
after use of the device, instructions on cleaning and disinfection of 
the device and to the skin to be pierced, and instructions for the safe 
disposal of the device (Ref. 2). For each environment of use for blood 
lancets, adequate labeling must be included to address either use of 
these devices in healthcare settings or labeling for home use that is 
written for the end users to be able to understand and follow the 
instructions.
    FDA has determined that general controls alone are not sufficient 
to provide a reasonable assurance of safety and effective for these 
devices (subsets 1, 2, and 3), and there is sufficient information to 
establish special controls to provide such an assurance; therefore, FDA 
is reclassifying these devices into class II (81 FR 11140 at 11142). 
The Panel consensus was that single patient use only blood lancets meet 
the statutory definition of a class II device and require labeling 
special controls related to the cleaning and disinfection of skin and 
blood lancets for single patient use devices to reasonably assure 
safety and effectiveness.
    (Comment 6) Some comments stated that the proposed 180-day 
timeframe is too short for manufacturers of single patient use blood 
lancets (subsets 1 to 3) to demonstrate conformance with the required 
special controls and submit a premarket notification (510(k)). The 
comments recommended timeframes ranging from 1 to 2 years for the 
submission of new 510(k)s for these types of blood lancets.
    (Response 6) FDA agrees with the commenters' concern that its 
proposal to not enforce compliance with the 510(k) requirement or 
special controls for single patient use only blood lancets until 180 
days after the effective date of the final order may not be enough time 
for all manufacturers of single patient use blood lancets to implement 
the required special controls and receive 510(k) clearance for those 
devices without prior 510(k) clearance. The typical review time for a 
510(k) is 90 days. However, if a 510(k) submission lacks the 
information necessary for the Agency to continue or complete review, 
FDA may issue a request for additional information to the submitter and 
place the 510(k) on hold pending receipt of a complete response to the 
identified deficiencies. FDA's current policy is to allow a sponsor 180 
days to respond to a request for additional information,\1\ resulting 
in a maximum review time of 270 days. Therefore, even if a submission 
were made on the effective date, there could be instances where a 
510(k) submission would remain pending beyond 180 days after the 
effective date of the final order. FDA, therefore, does not intend to 
enforce compliance with the 510(k) requirement or special controls 
until 1 year after the effective date of this final order for blood 
lancets for single patient use only that have been offered for sale 
prior to the publication of this final order but do not already have a 
510(k) clearance.
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    \1\ See page 6 of Guidance for Industry and Food and Drug 
Administration Staff entitled ``FDA and Industry Actions on 
Premarket Notification (510(k)) Submissions: Effect on FDA Review 
Clock and Goals'', available at https://www.fda.gov/media/73507/download.
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    (Comment 7) There were several comments relating to the Unique 
Device Identification labeling and data submission requirements. These 
requirements apply to all devices in commercial distribution as of 
their established Unique Device

[[Page 66184]]

Identification compliance date unless an exception or alternative 
applies. For those blood lancets that have been offered for sale prior 
to November 22, 2021, the comments: (1) Expressed concerns that the 
Unique Device Identification compliance date for class II and class III 
devices will have already passed when this order is published, and 
insufficient time will be provided to allow for compliance; (2) 
requested that a period of 2 or 3 years be provided for compliance with 
Unique Device Identification requirements; and (3) pointed out that 
industry anticipated that their class I devices would use the product's 
Universal Product Code (UPC) for purposes of unique device identifier 
(UDI) implementation as permitted under Sec.  801.40(d) (21 CFR 
801.40(d)), and that FDA has not provided a reasonable basis to remove 
these devices from this provision. These comments further requested 
that FDA grant a general exception or alternative to allow the devices 
subject to this order, regardless of their classification, to utilize 
their UPCs as their UDIs.
    (Response 7) There are three principal elements to Unique Device 
Identification requirements: Labeling with a UDI, direct marking of 
devices that are intended to be used more than once and intended to be 
reprocessed between uses, and data submission to the Global Unique 
Device Identification Database (GUDID) (see Sec.  801.20, 801.45, and 
830.300 (21 CFR 801.20, 801.45, and 830.300)). In addition, the Unique 
Device Identification final rule (78 FR 58786, September 24, 2013) (UDI 
Rule) added Sec.  801.18 (21 CFR 801.18), which requires certain dates 
on device labels to be in a standard format. As explained in the 
preamble to the UDI Rule, FDA aligned the compliance date for standard 
date format requirements under Sec.  801.18 with the compliance date by 
which a device must bear a UDI on its label and packages under Sec.  
801.20 to avoid the need to make changes to a device label more than 
once to implement the requirements in the final rule.\2\ FDA disagrees 
2 or 3 years is necessary for compliance with Unique Device 
Identification labeling and data submission requirements. Rather, FDA 
considered the commenters' request for additional time for compliance 
with UDI requirements and believes that the compliance timeframes set 
forth in section VI of this order provide sufficient time for 
manufacturers to perform all the functions required to comply with UDI 
labeling and data submission requirements, including converting 
manufacturing processes and associated inventory management, and 
submitting required information to GUDID. In addition, manufacturers 
should consult existing UDI compliance policies, which may be 
applicable to their reclassified devices. FDA's publicly available UDI 
web page \3\ contains a comprehensive listing of UDI guidance documents 
and compliance policies.
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    \2\ See 78 FR 58786 at 58795, September 24, 2013.
    \3\ Available at: https://www.fda.gov/udi.
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    FDA also disagrees that manufacturers of blood lancets should be 
permitted to utilize their UPCs as their UDIs. As indicated in the 
preamble to the UDI Rule (78 FR 58786 at 58798) the exception in Sec.  
801.40(d) was purposely limited to class I devices due to their 
relative low risk. For the reasons stated in the preamble to this 
order, FDA no longer considers the blood lancet devices to be low risk 
and is reclassifying them into class II and class III. Therefore, the 
exception in Sec.  801.40(d) will no longer apply to these devices, and 
FDA does not believe that a general exception or alternative to the UDI 
labeling requirements would not be appropriate. An individual labeler 
that believes a UPC rather than a UDI on its device label would provide 
for more accurate, precise, or rapid device identification or would 
better ensure the safety or effectiveness of the device, may submit a 
request for an alternative under 21 CFR 801.55.
    (Comment 8) Several comments stated that the proposed special 
controls are unclear and unnecessary for blood lancets for single 
patient use blood lancets. Other comments specifically requested 
clarification of the following special controls: (1) Design 
characteristics related to single use only blood lancets without an 
integral sharp injury prevention, (2) possible recognized consensus 
standards for mechanical performance testing, (3) sterility testing for 
the lancet only, and (4) FDA identification of recognized consensus 
standards for biocompatibility testing and clarification on whether 
testing should be completed for the finished product or only the 
lancet.
    (Response 8) FDA continues to believe that special controls are 
necessary for single patient use only blood lancets. At the Panel 
meeting, FDA presented an analysis of the risks to health associated 
with the use of blood lancets and new scientific data supporting these 
risks. These risks to health are summarized in tables 1 to 3 of the 
513(e) Proposed Order (81 FR 11140 at 11147). After deliberation, the 
Panel concluded that the risks to health warranted reclassification of 
blood lancets from class I devices, as general controls were deemed 
insufficient to provide a reasonable assurance of safety and 
effectiveness. The proposed special controls are intended to inform 
manufacturers of the testing and information FDA believes to be 
necessary to provide a reasonable assurance of safety and effectiveness 
during the use of blood lancets, including single patient use only 
blood lancets.
    FDA understands the confusion regarding the special control for 
single use only blood lancets without an integral sharps injury 
prevention feature regarding design to prevent sharp object injuries. 
The special controls for single patient use only blood lancets 
established by this final order are necessary to provide a reasonable 
assurance of safety and effectiveness for those devices. Each subset of 
blood lancets presents similar risks to health, but requires different 
special controls due to their different design characteristics and risk 
profiles. Design characteristics for blood lancets without an integral 
sharp injury prevention feature must still address the risks of sharp 
object injuries and bloodborne pathogen transmissions (see Sec.  
878.4850(b)(2)(i)). Examples of how this could be achieved include, but 
may not be limited to, the inclusion of a cap or blade cover. As 
described in the 513(e) Proposed Order (81 FR 11140) and adopted in 
this final order, these risks are also mitigated by mechanical 
performance testing to prevent device breakage and labeling. FDA 
believes that to satisfy the mechanical testing special control 
manufacturers must demonstrate injury prevention features (as 
applicable) and blade performance in single use single patient devices 
(see Sec.  878.4850(a)(2)(ii) and (b)(2)(ii)); however, there is 
currently no FDA-recognized consensus standard for mechanical tests, 
methods, or acceptance criteria for this device type.
    At the Panel meeting, FDA presented an analysis of the risks to 
health associated with the use of blood lancets and new scientific data 
supporting these risks. FDA believes that reusable components of single 
patient use devices, such as reusable bases, should be adequately 
cleaned and disinfected (i.e., reprocessed) between uses in order to 
prevent risk of infection. Sterility testing is applicable to any 
device component that breaches the skin, thereby contacting the 
underlying sterile tissue and/or blood in order to mitigate the risk of 
infection. While this requirement commonly applies to the blade of the 
blood lancet device, it may be possible for other components of a

[[Page 66185]]

blood lancet besides a ``blade'' to breach the skin. Therefore, FDA has 
determined that the sterility special control should be revised to 
clearly state that this special control applies to ``any device 
component that breaches the skin (e.g., the blade)'' for the three 
single patient use subtypes of blood lancets. The special control for 
biocompatibility testing must be conducted on the final finished form 
for the finished blood lancet device and is important to address the 
risk of adverse tissue reaction (not infection).
    Manufacturers are encouraged to review the relevant FDA guidance 
documents including, but not limited to the ``Submission and Review of 
Sterility Information in Premarket Notification (510(k)) Submissions 
for Devices Labeled as Sterile'' (Ref. 7) and ``Use of International 
Standard ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: 
Evaluation and Testing Within a Risk Management Process'' (Ref. 8) for 
recommendations on how to comply with the special control testing 
requirements.
    Evidence of compliance with the special controls is required to 
demonstrate reasonable assurance of safety and effectiveness and to 
support 510(k) clearance. As stated above, FDA does not intend to 
enforce compliance with the premarket notification (510(k)) requirement 
and special controls for blood lancets for single patient use only that 
have been offered for sale prior to the publication of this final order 
but do not already have a 510(k) clearance. However, 1 year after the 
effective date of this order, any: (1) Single use only blood lancet 
with an integral sharps injury prevention feature that does not comply 
with the special controls established in Sec.  878.4850(a)(2), (2) 
single use only blood lancet without an integral sharps injury 
prevention feature that does not comply with the special controls 
established in Sec.  878.4850(b)(2), or (3) multiple use blood lancet 
for single patient use only established in Sec.  878.4850(c)(2), will 
be considered adulterated and misbranded (sections 501(f)(1)(B) and 
502(o) of the FD&C Act (21 U.S.C. 351(f)(1)(B) and 352(o))) until such 
time as the device complies with the special controls and any premarket 
notification requirements.
    (Comment 9) A comment stated that currently marketed blood lancets 
should be exempt from design controls because the safety concerns 
raised by those single patient use devices are related to the labeling 
and the use of blood lancets generally and not with the design of the 
device. Instead the comment suggests a phased-in approach for design 
control compliance for currently marketed devices, depending on whether 
they meet the requirements pursuant to Sec.  807.81(a)(3) (21 CFR 
807.81(a)(3)).
    (Response 9) FDA disagrees with this comment. The lancet blade is 
designed to pierce the skin and draw blood and can present a puncture 
hazard to anyone coming into contact with the device when the blade is 
accessible. This hazard is associated with serious risks as described 
in the 513(e) Proposed Order (81 FR 11140). Without the application of 
design controls (21 CFR 820.30), FDA is unable to verify that 
appropriate controls are in place to ensure that blood lancet devices 
are designed and tested in such a way as to perform as intended under 
the labeled conditions of use, and to provide a reasonable assurance of 
safety and effectiveness. Therefore, FDA does not intend to allow a 
phased-in approach for design control compliance of currently marketed 
single patient use blood lancets.
    (Comment 10) A comment stated that the single patient use only 
blood lancet devices should be exempt from premarket notification under 
section 510(m) of the FD&C Act (21 U.S.C. 360(m)) and suggested that 
special controls could be documented in the Design History File (DHF) 
for FDA's review during routine audits/inspections.
    (Response 10) FDA does not agree that it is appropriate to exempt 
single patient use only blood lancets from premarket notification at 
this time. Section 510(m) of the FD&C Act provides that FDA may exempt 
a class II device from the premarket notification requirements under 
section 510(k) of the FD&C Act if FDA determines that premarket 
notification is not necessary to provide reasonable assurance of the 
safety and effectiveness of the device. There are a number of factors 
FDA may consider to determine whether a 510(k) is necessary to provide 
reasonable assurance of the safety and effectiveness of a class II 
device. These factors are discussed in the guidance that the Agency 
issued on February 19, 1998, entitled ``Procedures for Class II Device 
Exemptions from Premarket Notification, Guidance for Industry and CDRH 
Staff'' (Class II 510(k) Exemption Guidance) (Ref. 9). Based on the 
scientific information available to the Agency at this time and 
summarized in the 513(e) Proposed Order, FDA has determined these 
factors currently are not met for single patient use only blood lancet 
devices and that premarket notification is necessary to provide 
reasonable assurance of safety and effectiveness for all three types of 
single patient use blood lancets.
    FDA also does not agree with the comment that the Agency should 
only review the DHF for a single patient use only blood lancet device 
to determine whether there exists a reasonable assurance of safety and 
effectiveness for the device. Under 21 CFR 820.3 a DHF is a compilation 
of records that describes the design history of a finished device based 
on the quality system regulations. Although a manufacturer of a legally 
marketed device is required to keep a DHF for the device's design 
control requirements, FDA usually does not review the DHF until 
postmarket surveillance inspections of a class II device. For single 
patient use only blood lancet devices, based on the scientific evidence 
available to the Agency, FDA believes in order for the Agency to 
determine whether there exists a reasonable assurance of safety and 
effective for a device, it is necessary for compliance with the special 
controls to be assessed prior to the device entering the market.
    (Comment 11) A comment recommended that FDA create a separate 
regulatory classification category for ``flat, stainless steel'' blood 
lancets in class I.
    (Response 11) FDA disagrees that a separate regulatory 
classification is needed for flat, stainless steel blood lancets in 
class I. FDA believes that the four subsets of lancets identified in 
this final order encompass flat, stainless steel blood lancets; that 
is, a flat, stainless steel blood lancet can be appropriately 
categorized in any of these four subsets based on its intended use 
(e.g., single vs. multiple use) and design characteristics (e.g., 
presence or lack of a sharps injury prevention feature). Furthermore, 
at this time, FDA finds that the same risks to health (e.g., bloodborne 
pathogen transmission, local tissue infections, adverse tissue 
reactions) described herein for blood lancets apply to flat, stainless 
steel blood lancets. Therefore, FDA finds that a separate 
categorization for flat stainless steel blood lancets in class I is 
neither necessary nor appropriate at this time.
    (Comment 12) One comment suggested FDA allow a bundling of several 
devices with the same intended use for a 510(k) submission.
    (Response 12) Bundling refers to the inclusion of multiple devices 
or multiple indications for use for a device in a single premarket 
submission, including products subject to the device and biologics 
license application (BLA) authorities, for purposes of review and user 
fee payment. Multiple devices may include different models within a 
generic type of device (21 CFR 860.3) or

[[Page 66186]]

devices that are of differing generic types. Under the current review 
process for the Center for Devices and Radiological Health (CDRH), 
bundling of multiple devices or indications for use are acceptable for 
510(k) submission when the devices present scientific and regulatory 
issues that can most efficiently be addressed during the course of one 
premarket review (Ref. 10). CDRH will make a determination of 
acceptable bundling of devices on a case-by-case basis.
    (Comment 13) Some comments stated that all multiple use lancets 
should be class III.
    (Response 13) FDA disagrees with this comment. FDA believes the 
regulatory requirements for blood lancets should be based upon the 
indications for use of the device and the risk of the device when used 
as intended. After reviewing the new scientific data supporting the 
identified risks to health, the Panel recommended that reclassifying 
subset 3, multiple use for single patient use blood lancets from class 
I (general controls) to class II (special controls) because multiple 
use blood lancet devices for single use patients do not present a 
potential unreasonable risk of illness or injury due to the inherent 
and significantly increased risk of bloodborne pathogen transmission as 
compared to multiple patient blood lancets (Ref. 2). As stated above in 
response to Comment 2 in this section and in the 513(e) Proposed Order 
(81 FR 11140 at 11148), FDA believes sufficient information exists to 
establish special controls for mitigating the risks to health for 
subset 3 (multiple use for single patient use only blood lancets) to 
provide a reasonable assurance of safety and effectiveness of the 
device. Because multiple use blood lancets for multiple patient use 
present a potential unreasonable risk of illness or injury and 
insufficient information exists to establish special controls for 
multiple use blood lancets for multiple patient use, FDA reclassified 
the device into class III.
    (Comment 14) Some comments stated that the wording of the subtypes 
in the 513(e) Proposed Order were unclear and should be revised to 
distinguish between lancets and lancing medical devices.
    (Response 14) FDA understands the concerns of the commenter and is 
providing in this final order language to explain whether blades are 
attached to the base in each of the four subsets of blood lancets. The 
base and blade combine to create the complete lancet. For subset 1 and 
2 lancets, the blade is attached to the base with the entire unit being 
single use. In subset 3 and 4 lancets, single use blades are attached 
to a multiuse base where the blade is discarded after each use, but 
each subset has a different labeling requirement. By definition, 
subsets 1 and 2 blood lancets do not have a blade that can be used 
independently of the base. Furthermore, FDA provides clear descriptions 
of special controls that apply to each component for subsets 1, 2, and 
3. As discussed at the Panel, multiple use lancets for multiple 
patients present an unreasonable risk of illness or injury due to the 
inherent and significantly increased risk of bloodborne pathogen 
transmission and are therefore reclassified into class III. Therefore, 
FDA believes that the blood lancet definitions presented during the 
Panel meeting and provided in the 513(e) Proposed Order are complete 
and adequate.
    (Comment 15) Comment stated that FDA's increase of postmarket 
surveillance of blood glucose meter accuracy would provide greater 
impact on mitigating cross-contamination opportunities than 
reclassification of blood lancets.
    (Response 15) Postmarket surveillance of blood glucose meter 
accuracy is outside the scope of this regulatory action.

IV. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings 
as published in the preamble to the 513(e) Proposed Order for these 
devices (81 FR 11140). FDA is issuing this final order to reclassify 
single patient use only blood lancets devices from class I (general 
controls) exempt from premarket notification into class II (special 
controls) and subject to premarket review.\4\ FDA is reclassifying 
these devices based on the determination that general controls are 
insufficient to provide a reasonable assurance of safety and 
effectiveness for blood lancets and there is sufficient information to 
establish special controls to provide such assurance for single patient 
use only blood lancets (subsets 1 to 3). FDA is also establishing 
special controls for each type of single patient use only blood lancet, 
which are set forth in Sec.  878.4850(a)(2)(i) through (vi) for single 
use only blood lancet with an integral sharps injury prevention 
feature, Sec.  878.4850(b)(2)(i) through (vi) for single use only blood 
lancet without an integral sharps injury prevention feature, and Sec.  
878.4850(c)(2)(i) through (vii) for multiple use blood lancet for 
single patient use only. FDA also intends not to enforce compliance 
with this final order until 1 year after its effective date for 
manufacturers of blood lancets for single patient use only that are 
currently marketed for sale prior to the publication of this final 
order, but do not already have a 510(k) clearance.
---------------------------------------------------------------------------

    \4\ 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 is also issuing this final order to reclassify multiple use 
blood lancets for multiple patient use from class I (general controls) 
exempt from premarket notification into class III (premarket approval). 
FDA is reclassifying these devices based on the determination that 
general controls and special controls together are not sufficient to 
provide reasonable assurance of safety and effectiveness for this 
device. In addition, in the absence of an established positive benefit-
risk profile, FDA has determined that the risks to health associated 
with the use of multiple patient use blood lancets identified 
previously present a potential unreasonable risk of illness or injury. 
Elsewhere in this issue of the Federal Register, FDA has published a 
final order requiring the filing of a PMA or notice of completion of a 
PDP for multiple patient use blood lancets.
    FDA has also modified the identification in Sec.  878.4800(a) for 
manual surgical instruments for general use to remove the blood lancet 
devices from this classification regulation and include them under a 
separate classification regulation Sec.  878.4850.

V. Premarket Notification Requirement for Single Patient Use Only Blood 
Lancets

    FDA is reclassifying single patient use only blood lancets from 
class I (general controls) exempt from premarket notification into 
class II (special controls) and subject to premarket review. Section 
510(m) of the FD&C Act provides that FDA may exempt a class II device 
from the premarket notification requirements under section 510(k) of 
the FD&C Act if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of safety and 
effectiveness for the intended uses of all three types of single 
patient use only blood lancets. Therefore, these three device types are 
not exempt from premarket notification requirements.

[[Page 66187]]

    FDA cleared several 510(k)s for blood lancets prior to exempting 
the device types from submission of a premarket notification. These 
cleared blood lancets, as well as any 510(k)-exempt blood lancets 
legally offered for sale on or before November 22, 2021, can serve as 
predicates for substantial equivalence purposes. In order for a single 
patient use only blood lancet to fall within this classification, it 
would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order.

VI. Implementation Strategy

    For the three types of blood lancets being reclassified from class 
I (general controls) to class II (special controls), the special 
controls identified in this order are effective November 22, 2021. For 
the fourth type of blood lancet being reclassified from class I to 
class III, FDA is publishing a final order to require the filing of a 
PMA or notice of completion of a PDP elsewhere in this issue of the 
Federal Register.
     Blood lancets for single patient use only that have not 
been offered for sale prior to November 22, 2021, or have been offered 
for sale but are required to submit a new 510(k) under Sec.  
807.81(a)(3): Manufacturers are required to obtain 510(k) clearance 
before marketing their devices after November 22, 2021. 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.
     Blood lancets for single patient use only that have been 
offered for sale prior to November 22, 2021, and do not already have 
510(k) clearance: FDA does not intend to enforce compliance with the 
510(k) requirement or special controls until November 22, 2022. After 
that date, if a manufacturer continues to market such a device but does 
not have a 510(k) clearance or FDA determines that the device is not 
substantially equivalent or not compliant with the special controls, 
then FDA would consider taking action against such manufacturer under 
its usual enforcement policies.
    For blood lancets for single patient 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 compliance with the special controls. 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 be stated in the 
publicly available 510(k) Summary posted in this database. Because many 
blood lancets for single patient use are non-prescription (``over-the-
counter'') devices, FDA believes that our public database is a 
transparent tool allowing consumers to confirm that their devices have 
been submitted under a new 510(k) and demonstrated conformance to the 
applicable special controls.
    The timeframes set forth in this section also apply to compliance 
with requirements for device labeling (part 801 (21 CFR part 801)), 
including the UDI labeling requirements (part 801, subpart B), as well 
as device tracking requirements (21 CFR part 821), device reporting 
requirements (21 CFR part 803), and GUDID data submission requirements 
(21 CFR part 830).

VII. Codification of Orders

    Prior to the amendments by the Food and Drug Administration Safety 
and Innovation Act (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, FDASIA also provides for FDA to revoke previously issued 
regulations by order. FDA will continue to codify classifications and 
reclassifications in the Code of Federal Regulations (CFR). Changes 
resulting from final orders will appear in the CFR as changes to 
codified classification determinations or as newly codified orders. 
Therefore, under section 513(e)(1)(A)(i) of the FD&C Act, as amended by 
FDASIA, in this final order, we are revoking the requirements in 21 CFR 
878.4800 related to the classification of blood lancets as class I 
devices and codifying the reclassification of four types of blood 
lancets in 21 CFR 878.4850: Single use only blood lancets with an 
integral sharps injury prevention feature, single use only blood 
lancets without an integral sharps injury prevention feature, and 
multiple use blood lancets for single patient use only into class II, 
and multiple use blood lancet for multiple patient use into class III.

VIII. 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.

IX. Paperwork Reduction Act of 1995

    While this final order contains no collection of information, it 
does refer to previously approved FDA 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. 3501-3521) is not 
required for this final order. The previously approved collections of 
information are subject to review by OMB under the PRA. 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 814, subparts A through E, have been approved under OMB control 
number 0910-0231; the collections of information in 21 CFR part 820 
have been approved under OMB control number 0910-0073; the collections 
of information in 21 CFR part 830 have been approved under OMB control 
number 0910-0720; and the collections of information in 21 CFR parts 
800, 801 and 809 have been approved under OMB control number 0910-0485.
    The labeling provisions in proposed Sec.  878.4850(a)(2)(vi), 
(b)(2)(vi), and (c)(2)(vii) are not subject to review by OMB because 
they do not constitute a ``collection of information'' under the PRA. 
Rather, the following labeling: (1) ``For use only on a single patient. 
Discard the entire device after use.''; (2) ``For use only on a single 
patient. Disinfect reusable components according to manufacturer's 
instructions between each use.''; (3) ``Used lancet blades must be 
safely discarded after a single use.''; (4) ``Warning: Not intended for 
more than one use. Do not use on more than one patient. Improper use of 
blood lancets can increase the risk of inadvertent transmission of 
bloodborne pathogens, particularly in settings where multiple patients 
are tested.''; and (5) ``Warning: Do not use on more than one patient. 
Improper use of blood lancets can increase the risk of inadvertent 
transmission of bloodborne pathogens, particularly in settings where 
multiple patients are tested. The cleaning and disinfection 
instructions for this device are intended only to reduce the risk of 
local use site infection; they cannot render this device safe for use 
for more than one patient.'' are a ``public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)).

X. References

    The following references marked with an asterisk (*) are on display 
at the

[[Page 66188]]

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 Guidance for Industry and FDA Staff, ``Self-Monitoring Blood 
Glucose Test Systems for Over-the-Counter Use,'' September 2020, 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-blood-glucose-test-systems-over-counter-use.
2. *Executive Summary, Transcript and other meeting material of the 
June 26, 2013, meeting of the General and Plastic Surgery Devices 
Panel available at https://wayback.archive-it.org/7993/20170405193132/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm349426.htm.
3. *FDA Guidance for Industry and FDA Staff, ``Reprocessing Medical 
Devices in Health Care Settings: Validation Methods and Labeling,'' 
March 17, 2015, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling.
4. *FDA Guidance for Industry and FDA Staff, ``Blood Glucose 
Monitoring Test Systems for Prescription Point-of-Care Use,'' 
September 2020, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/blood-glucose-monitoring-test-systems-prescription-point-care-use.
5. *The World Health Organization (WHO) Guidelines on Drawing Blood: 
Best Practices in Phlebotomy, Part II, 2, Geneva: World Health 
Organization, 2010, available at https://www.ncbi.nlm.nih.gov/books/NBK138665/.
6. Clinical Laboratory Standards Institute (CLSI), GP42 7th Edition, 
Collection of Capillary Blood Specimens.
7. *FDA Guidance for Industry and FDA Staff, ``Submission and Review 
of Sterility Information in Premarket Notification (510(k)) 
Submissions for Devices Labeled as Sterile,'' January 21, 2016, 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled.
8. *FDA Guidance for Industry and FDA Staff, ``Use of International 
Standard ISO 10993-1, Biological Evaluation of Medical Devices--Part 
1: Evaluation and Testing Within a Risk Management Process,'' 
September 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.
9. *``Procedures for Class II Device Exemptions from Premarket 
Notification,'' Guidance for Industry and CDRH Staff (Class II 
510(k) Exemption Guidance), February 19, 1998, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.
10. *FDA Guidance for Industry and FDA Staff, ``Bundling Multiple 
Devices or Multiple Indications in a Single Submission,'' June 20, 
2007, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bundling-multiple-devices-or-multiple-indications-single-submission.

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. Amend Sec.  878.4800 by revising 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, 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, stapler, 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.
* * * * *

0
3. Add Sec.  878.4850 to subpart E to read as follows:


Sec.  878.4850  Blood lancets.

    (a) Single use only blood lancet with an integral sharps injury 
prevention feature--(1) Identification. A disposable blood lancet 
intended for a single use that is comprised of a single use blade 
attached to a solid, non-reusable base (including an integral sharps 
injury prevention feature) that is used to puncture the skin to obtain 
a drop of blood for diagnostic purposes. The integral sharps injury 
prevention feature allows the device to be used once and then renders 
it inoperable and incapable of further use.
    (2) Classification. Class II (special controls). The special 
controls are:
    (i) The design characteristics of the device must ensure that the 
structure and material composition are consistent with the intended use 
and must include a sharps injury prevention feature.
    (ii) Mechanical performance testing must demonstrate that the 
device will withstand forces encountered during use and that the 
integral sharps injury prevention feature will irreversibly disable the 
device after one use.
    (iii) The device must be demonstrated to be biocompatible.
    (iv) Sterility testing must demonstrate the sterility of any device 
component that breaches the skin (e.g., blade).
    (v) Labeling must include:
    (A) Detailed descriptions, with illustrations, of the proper use of 
the device and its sharps injury prevention feature.
    (B) Handwashing instructions for the user before and after use of 
the device.
    (C) Instructions on preparation (e.g., cleaning, disinfection) of 
the skin to be pierced.
    (D) Instructions for the safe disposal of the device.
    (E) Labeling must be appropriate for the intended use environment.
    (1) For those devices intended for health care settings, labeling 
must address the health care facility use of these devices, including 
how these lancets are to be used with personal protective equipment, 
such as gloves.

[[Page 66189]]

    (2) For those devices intended for use in the home, labeling must 
be written so that it is understandable to lay users.
    (vi) Labeling must also include the following statements, 
prominently placed:
    (A) ``For use only on a single patient. Discard the entire device 
after use.''
    (B) ``Warning: Not intended for more than one use. Do not use on 
more than one patient. Improper use of blood lancets can increase the 
risk of inadvertent transmission of bloodborne pathogens, particularly 
in settings where multiple patients are tested.''
    (b) Single use only blood lancet without an integral sharps injury 
prevention feature--(1) Identification. A disposable blood lancet 
intended for a single use that is comprised of a single use blade 
attached to a solid, non-reusable base that is used to puncture the 
skin to obtain a drop of blood for diagnostic purposes.
    (2) Classification. Class II (special controls). The special 
controls are:
    (i) The design characteristics of the device must ensure that the 
structure and material composition are consistent with the intended use 
and address the risk of sharp object injuries and bloodborne pathogen 
transmissions.
    (ii) Mechanical performance testing must demonstrate that the 
device will withstand forces encountered during use.
    (iii) The device must be demonstrated to be biocompatible.
    (iv) Sterility testing must demonstrate the sterility of any device 
component that breaches the skin (e.g., blade).
    (v) Labeling must include:
    (A) Detailed descriptions, with illustrations, of the proper use of 
the device.
    (B) Handwashing instructions for the user before and after use of 
the device.
    (C) Instructions on preparation (e.g., cleaning, disinfection) of 
the skin to be pierced.
    (D) Instructions for the safe disposal of the device.
    (E) Labeling must be appropriate for the intended use environment.
    (1) For those devices intended for health care settings, labeling 
must address the health care facility use of these devices, including 
how these lancets are to be used with personal protective equipment, 
such as gloves.
    (2) For those devices intended for use in the home, labeling must 
be written so that it is understandable to lay users.
    (vi) Labeling must also include the following statements, 
prominently placed:
    (A) ``For use only on a single patient. Discard the entire device 
after use.''
    (B) ``Warning: Not intended for more than one use. Do not use on 
more than one patient. Improper use of blood lancets can increase the 
risk of inadvertent transmission of bloodborne pathogens, particularly 
in settings where multiple patients are tested.''
    (c) Multiple use blood lancet for single patient use only--(1) 
Identification. A multiple use capable blood lancet intended for use on 
a single patient that is comprised of a single use blade attached to a 
solid, reusable base that is used to puncture the skin to obtain a drop 
of blood for diagnostic purposes.
    (2) Classification. Class II (special controls). The special 
controls are:
    (i) The design characteristics of the device must ensure that:
    (A) The lancet blade can be changed with every use, either manually 
or by triggering a blade storage unit to discard the used blade and 
reload an unused blade into the reusable base; and
    (B) The structure and material composition are consistent with the 
intended use and address the risk of sharp object injuries and 
bloodborne pathogen transmissions and allow for validated cleaning and 
disinfection.
    (ii) Mechanical performance testing must demonstrate that the 
device will withstand forces encountered during use.
    (iii) The device must be demonstrated to be biocompatible.
    (iv) Sterility testing must demonstrate the sterility of any device 
component that breaches the skin (e.g., blade).
    (v) Validation testing must demonstrate that the cleaning and 
disinfection instructions are adequate to ensure that the reusable 
lancet base can be cleaned and low level disinfected.
    (vi) Labeling must include:
    (A) Detailed descriptions, with illustrations, of the proper use of 
the device.
    (B) The Environmental Protection Agency (EPA) registered 
disinfectant's contact time for disinfectant use.
    (C) Handwashing instructions for the user before and after use of 
the device.
    (D) Instructions on preparation (e.g., cleaning, disinfection) of 
the skin to be pierced.
    (E) Instructions on the cleaning and disinfection of the device.
    (F) Instructions for the safe disposal of the device.
    (G) Instructions for use must address the safe storage of the 
reusable blood lancet base between uses to minimize contamination or 
damage and the safe storage and disposal of the refill lancet blades.
    (H) Labeling must be appropriate for the intended use environment.
    (1) For those devices intended for health care settings, labeling 
must address the health care facility use of these devices, including 
how these lancets are to be used with personal protective equipment, 
such as gloves.
    (2) For those devices intended for use in the home, labeling must 
be written so that it is understandable to lay users.
    (vii) Labeling must also include the following statements, 
prominently placed:
    (A) ``For use only on a single patient. Disinfect reusable 
components according to manufacturer's instructions between each use.''
    (B) ``Used lancet blades must be safely discarded after a single 
use.''
    (C) ``Warning: Do not use on more than one patient. Improper use of 
blood lancets can increase the risk of inadvertent transmission of 
bloodborne pathogens, particularly in settings where multiple patients 
are tested. The cleaning and disinfection instructions for this device 
are intended only to reduce the risk of local use site infection; they 
cannot render this device safe for use for more than one patient.''
    (d) Multiple use blood lancet for multiple patient use--(1) 
Identification. A multiple use capable blood lancet intended for use on 
multiple patients that is comprised of a single use blade attached to a 
solid, reusable base that is used to puncture the skin to obtain a drop 
of blood for diagnostic purposes.
    (2) Classification. Class III (premarket approval).

    Dated: November 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25376 Filed 11-19-21; 8:45 am]
BILLING CODE 4164-01-P


