Document ID: FDA-2016-N-0400-0001
Agency: fda
Document Type: Proposed Rule
Title: General and Plastic Surgery Devices; Reclassification of Blood Lancets
Posted Date: 2016-03-03T05:00Z

[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Proposed Rules]
[Pages 11140-11151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04578]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

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

General and Plastic Surgery Devices; Reclassification of Blood 
Lancets

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
proposing to reclassify the following 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 review: 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 identifying proposed special controls for these types 
of blood lancets that we believe are necessary to provide a reasonable 
assurance of safety and effectiveness. FDA is also proposing 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 proposing the reclassification 
of these four types of blood lancets on its own initiative based on new 
information.

DATES: Submit either electronic or written comments on the proposed 
order by June 1, 2016. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 (PRA) by April 4, 2016, (see 
the ``Paperwork Reduction Act of 1995'' section of this document). See 
section X of the SUPPLEMENTARY INFORMATION section of this document for 
the proposed effective date of any final order that may publish based 
on this proposal.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

[[Page 11141]]

written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0400 for ``General and Plastic Surgery Devices; 
Reclassification of Blood Lancets.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit comments on information collection issues to the Office of 
Management and Budget (OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to 
oira_submission@omb.eop.gov. All comments should be identified with the 
title, ``General and Plastic Surgery Devices; Reclassification of Blood 
Lancets.''

FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G422, Silver Spring, MD 20993-0002, 301-796-6524; 
or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, 
Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), 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).
    Section 513(a)(1) of the FD&C Act defines the three classes of 
devices. Class I devices are those devices for which the general 
controls of the FD&C Act (controls authorized by or under section 501, 
502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 
360i, or 360j) or any combination of such sections) are sufficient to 
provide reasonable assurance of safety and effectiveness; or those 
devices for which insufficient information exists to determine that 
general controls are sufficient to provide reasonable assurance of 
safety and effectiveness or to establish special controls to provide 
such assurance, but because the devices are not purported or 
represented to be for a use in supporting or sustaining human life or 
for a use which is of substantial importance in preventing impairment 
of human health, and do not present a potential unreasonable risk of 
illness or injury, are to be regulated by general controls (section 
513(a)(1)(A) of the FD&C Act). Class II devices are those devices for 
which general controls by themselves are insufficient to provide 
reasonable assurance of safety and effectiveness, but for which there 
is sufficient information to establish special controls to provide such 
assurance, including the promulgation of performance standards, 
postmarket surveillance, patient registries, development and 
dissemination of guidelines, recommendations, and other appropriate 
actions the Agency deems necessary to provide such assurance (section 
513(a)(1)(B) of the FD&C Act). Class III devices are those devices for 
which insufficient information exists to determine that general 
controls and special controls would provide a reasonable assurance of 
safety and effectiveness, and are purported or represented for a use in 
supporting or sustaining human life or for a use which is of 
substantial importance in preventing impairment of human health, or 
present a potential unreasonable risk of illness or injury (section 
513(a)(1)(C) of the FD&C Act). Under section 513(d)(1) of the FD&C Act, 
devices that were in commercial distribution before the enactment of 
the 1976 amendments, May 28, 1976 (generally referred to as 
``preamendments devices''), are classified after FDA: (1) Receives a 
recommendation from a device classification panel (an FDA advisory 
committee); (2) publishes the panel's recommendation for comment, along 
with a proposed regulation classifying the device; and (3) publishes 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 
classified automatically by section 513(f) 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: FDA reclassifies 
the device into class I or II; or 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

[[Page 11142]]

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 (21 U.S.C. 360(k)) and part 807 of the regulations (21 
CFR part 807). A person may market a preamendments device that has been 
classified into class III through premarket notification procedures 
without submission of a PMA until FDA issues a final order under 
section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket 
approval.
    On July 9, 2012, Congress enacted the Food and Drug Administration 
Safety and Innovation Act (FDASIA). Section 608(a) of FDASIA amended 
section 513(e) of the FD&C Act, changing the reclassification process 
from rulemaking to administrative order. Section 513(e)(1) of the FD&C 
Act sets forth the process for issuing a final order. Specifically, 
prior to the issuance of a final order reclassifying a device, the 
following must occur: Publication of a proposed order in the Federal 
Register, a meeting of a device classification panel described in 
section 513(b) of the FD&C Act, and 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 risk of the device. (See section 
513(e)(1)(A)(i) of the FD&C Act.)
    Section 513(e)(1) provides that FDA may, by administrative order, 
reclassify a device based on ``new information.'' FDA can initiate a 
reclassification under section 513(e) or an interested person may 
petition FDA. The term ``new information,'' as used in section 513(e) 
of the FD&C Act, includes information developed as a result of a 
reevaluation of the data before the Agency when the device was 
originally classified, as well as information not presented, not 
available, or not developed at that time. (See, e.g., Holland-Rantos v. 
United States Dep't of Health, Educ. & Welfare, 587 F.2d 1173, 1174 n.1 
(D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell 
v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 
F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in ``medical 
science.'' (See Upjohn v. Finch, 422 F.2d at 951.) Whether data before 
the Agency are past or new data, the ``new information'' to support 
reclassification under section 513(e) must be ``valid scientific 
evidence,'' as defined in section 513(a)(3) of the FD&C Act and 21 CFR 
860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. 
Cir. 1985); Contact Lens Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 
1985), cert. denied, 474 U.S. 1062 (1985).)

II. Regulatory History of the Device

    Blood lancets were classified in part 878 (21 CFR part 878) in a 
final rule published in the Federal Register on June 24, 1988 (53 FR 
23856) that classified 51 general and plastic surgery devices. This 
1988 rule classified blood lancets into class I (general controls). 
These devices were grouped with other devices under ``Manual surgical 
instrument for general use'' in Sec.  878.4800 (21 CFR 878.4800). At 
the time, blood lancets had been in common use in medical practice for 
many years, and FDA believed that general controls were sufficient to 
provide reasonable assurance of the safety and effectiveness of those 
devices. The rule was amended on April 5, 1989 (54 FR 13826) to clarify 
that manual surgical instruments for general use made of the same 
materials as used in preamendment devices were exempt from premarket 
notification 510(k) review.
    On December 7, 1994, FDA further amended the classification when it 
published a final rule in the Federal Register (59 FR 63005) that 
exempted 148 class I devices from premarket notification, with 
limitations. Blood lancets were one of those devices. FDA determined 
that manufacturers' submissions of premarket notifications were 
unnecessary for the protection of the public health and that FDA's 
review of such submissions would not advance its public health mission.
    On August 26, 2010, FDA and the Centers for Disease Control and 
Prevention (CDC) issued a joint initial communication warning that the 
use of fingerstick devices (blood lancets) to obtain blood from more 
than one patient posed a risk of transmitting bloodborne pathogens. The 
communication was updated on November 29, 2010 (Ref. 1). FDA's 
communication update, ``Use of Fingerstick Devices on More Than One 
Person Poses Risk for Transmitting Bloodborne Pathogens: Initial 
Communication: Update 11/29/2010'' stated that ``[o]ver the past 10-15 
years, the CDC and FDA have noted a progressive increase in reports of 
bloodborne infection transmission (primarily hepatitis B virus [HBV]) 
resulting from the shared use of fingerstick and POC [or `Point of 
Care'] blood testing devices.'' FDA and CDC recommended, among other 
things, that health care professionals and patients never use a blood 
lancet for more than one person.
    On November 29, 2010, FDA published a guidance entitled ``Guidance 
for Industry and Food and Drug Administration Staff; Blood Lancet 
Labeling'' (75 FR 73107) (Ref. 2). This guidance includes labeling 
recommendations to address concerns that both health care providers and 
patients may be unaware of the serious adverse health risks associated 
with using the same blood lancet for assisted withdrawal of blood from 
more than one patient, even when the blood lancet blade is changed for 
each blood draw. FDA recommends in the guidance that all blood lancets 
be labeled for use only on a single patient. FDA recommends in the 
guidance that a statement limiting use to a single patient should also 
appear on the label attached to the device, if possible. The guidance 
was for immediate implementation. When final, this order will supersede 
this labeling guidance.
    On June 26, 2013, FDA held a meeting of the General and Plastic 
Surgery Devices Panel of the Medical Devices Advisory Committee (the 
Panel) to discuss the potential reclassification of blood lancets (Ref. 
3). The Panel discussed new scientific information (see section VII of 
this document), the risks to health from blood lancets, whether blood 
lancets should be reclassified or remain in class I, and possible 
special controls for these devices if reclassified into class II. The 
Panel agreed that general controls were not sufficient to provide a 
reasonable assurance of safety and effectiveness of any of the four 
types of blood lancets (the four types are explained in section III). 
The Panel believed that because multiple use blood lancets for multiple 
patient use presented a potential unreasonable risk of illness or 
injury, and insufficient information existed to establish special 
controls for these devices, they should be reclassified into class III. 
The Panel recommended that all other blood lancet devices be 
reclassified into class II (special controls). FDA is not aware of new 
information since this Panel meeting that would provide a basis for a 
different recommendation or findings.

III. Device Description

    A blood lancet is used to puncture the skin to obtain small blood 
specimens for testing blood glucose, hemoglobin, and

[[Page 11143]]

other blood components. Some blood lancets are used with POC blood 
testing devices, such as blood glucose meters and Prothrombin Time and 
International Normalized Ratio (PT/INR) anticoagulation meters. Today, 
probably the most common use for a blood lancet is in diabetes 
monitoring. These devices are used in both home and professional health 
care settings. Only a small blood sample is needed for testing of blood 
glucose level. The blood sample is dropped onto a test strip and 
inserted into a blood glucose meter for results.
    FDA has identified four subsets of blood lancets:
    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;
    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;
    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; 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.

IV. Proposed Reclassification

A. Single Patient Use Only Blood Lancets

    FDA is proposing to reclassify the following three subsets of blood 
lancets from class I (general controls) exempt from premarket review to 
class II (special controls) and subject to premarket review: (1) Single 
use only blood lancets with an integral sharps injury prevention 
feature, (2) single use only blood lancets without an integral sharps 
injury prevention feature, and (3) multiple use blood lancets for 
single patient use only. FDA believes that general controls by 
themselves are insufficient to provide reasonable assurance of safety 
and effectiveness for these devices, and that there is sufficient 
information to establish special controls to provide such assurance.
    The Food and Drug Administration Modernization Act (FDAMA) (Pub. L. 
105-115) added section 510(m) to 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. The 
Agency does not intend to exempt these devices from premarket 
notification (510(k)) submission as allowed under section 510(m) of the 
FD&C Act. FDA believes premarket notification is necessary for these 
devices to provide a reasonable assurance of safety and effectiveness.

B. Multiple Patient Use Blood Lancets

    FDA is proposing that a fourth subset of blood lancets, multiple 
use blood lancets for multiple patient use, be reclassified from class 
I (general controls) without premarket review to class III (premarket 
approval). FDA believes that insufficient information exists to 
determine that general controls and special controls would provide a 
reasonable assurance of safety and effectiveness for these devices, 
which present a potential unreasonable risk of illness or injury (see 
section 513(a)(1)(C) of the FD&C Act).
    Elsewhere in this issue of the Federal Register, FDA is proposing 
to require the filing of a PMA or notice of completion of a product 
development protocol (PDP) for these devices, which will be finalized 
only if FDA reclassifies multiple use blood lancets for multiple 
patient use to class III.
    FDA continues to believe that multiple use blood lancets for use in 
multiple patients present significant risks to public health. 
Specifically, multiple patient use blood lancets pose a risk of 
transmission of bloodborne pathogen infections, including HBV and 
hepatitis C. Bloodborne pathogens may be transmitted between patients 
by blood or blood products taken from a patient with a transmissible 
infection. FDA believes that certain design characteristics would be 
required to help mitigate these risks. For example, multiple use blood 
lancets for use in multiple patients would need to be designed to allow 
for rigorous, thorough cleaning plus a disinfection or sterilization 
process capable of reduction of bloodborne pathogens to a clinically 
acceptable level between each use in a different patient in order to be 
safe for this intended use. The cleaning and disinfection/sterilization 
process to be used to render a multiple use blood lancet safe for use 
in multiple patients would need to be effective in spite of potential 
health care provider noncompliance with manufacturer's Instructions for 
Use. More importantly, the multiple use blood lancet for use in 
multiple patients would need to be designed such that repeat operation 
of the device is not possible until the device has been thoroughly 
cleaned and disinfected, using validated processes, by the health care 
user. Such a mechanism is necessary to prevent health care providers, 
especially those working in facilities that provide relatively little 
staff education or supervision, such as assisted living facilities 
(ALF), from failing to comply with manufacturer recommendations 
regarding rendering multiple patient use blood lancets safe for use in 
more than one patient. Therefore, the safety of the multiple use blood 
lancets for multiple patients, especially the effectiveness of their 
design and reprocessing instructions to render the device safe for use 
on more than one patient and the ability of health care providers to 
follow these instructions completely, must be rigorously demonstrated, 
independently of any other blood lancet. Because blood lancets for use 
on multiple patients present a potential unreasonable risk of illness 
or injury and insufficient information exists for FDA to determine that 
special controls would provide reasonable assurance of safety and 
effectiveness of the device, the Agency believes that these devices 
should be reclassified into class III.

V. Public Health Benefits and Risks to Health

    As required by section 513(e)(1)(A)(I) of the FD&C Act, FDA is 
providing a substantive summary of the valid scientific evidence 
regarding the public health benefit of blood lancets, and the nature 
and, if known, the incidence of the risk of the devices. Since the 
1990s, because of outbreaks of HBV infections associated with blood 
lancets and meters used in blood glucose monitoring, CDC and FDA have 
recommended that blood lancets should be limited to one individual's 
use (Refs. 1 and 4 to 6). Nevertheless, there have been continuing 
reports of bloodborne pathogen transmission from the shared use of 
blood lancets. Improper use of blood lancets can endanger public 
health, and FDA is concerned about the persistent risk of transmission 
of

[[Page 11144]]

hepatitis and other bloodborne pathogens when blood lancets are used to 
obtain blood from more than one patient in health care settings. 
Certain bloodborne pathogens, such as HBV, are very stable at ambient 
temperatures and HBV infected patients, who often lack clinical 
symptoms of hepatitis, can have high concentrations of HBV in their 
blood or body fluids, thus serving as unsuspected sources of the 
infectious agent available for transmission to other patients when 
blood lancets are misused (Refs. 7 to 32).
    These findings were discussed by the June 26, 2013, General and 
Plastic Surgery Devices Panel. The Panel agreed that the risks to 
health identified in this section are applicable to blood lancet 
devices, particularly the risk of cross-contamination between patients 
when the same lancet is used on multiple patients (Ref. 3).
    After considering the information discussed by the Panel and in 
published literature, as well as medical device reports relating to 
blood lancets, and reported outbreaks of various bloodborne pathogen 
infections, FDA believes that the risks to health associated with the 
use of blood lancets are (1) bloodborne pathogen transmission, (2) 
sharp object injuries, (3) local tissue infections, and (4) adverse 
tissue reaction (not infection). The June 26, 2013, Panel also believed 
that these were the risks for the device (Ref. 3).

A. Bloodborne Pathogen Transmission

    Bloodborne pathogens such as HBV, hepatitis C virus, and 
potentially any other pathogen present in the bloodstream of a patient 
can be transmitted from one patient to another by the following 
mechanisms:
     Reuse of the same lancet blade to draw blood from more 
than one patient or
     Failure/inability to adequately clean the base of a 
multiple use blood lancet resulting in the blood contamination of the 
next ``new'' lancet blade when blood is drawn from more than one 
patient.

B. Sharp Object Injuries

    The blade of a blood lancet device is designed to pierce the skin 
and draw blood. Except when the used lancet blade is immediately and 
automatically covered by a sharps safety feature, which renders the 
blade inaccessible, the exposed sharp blade of a blood lancet presents 
a puncture hazard to anyone coming in contact with it. Blade exposure 
can result due to either the lack of a sharps safety feature or device 
breakage.

C. Local Tissue Infections

    Human skin always carries a population of bacteria and often fungi 
(normal skin flora), which causes no problem for the host when skin is 
intact. However, puncture injuries to the skin by sharp objects such as 
blood lancet blades can carry these microbes into the normally sterile 
tissue below the skin. Such injuries have the potential to cause local 
skin/soft tissue infections.

D. Adverse Tissue Reaction (Not Infection)

    Tissue contact with some materials, metals, and material colorants 
can cause skin inflammation, irritation, or exanthems (rashes). These 
reactions may be due to either hypersensitivity to a specific compound/
metal or to a non-specific reaction.

VI. Summary of Reasons for Reclassification

    FDA believes that blood lancets for use on a single patient only 
should be reclassified into class II because special controls, in 
addition to general controls, can be established to provide reasonable 
assurance of safety and effectiveness of the device. FDA further 
believes that blood lancets for use on multiple patients should be 
reclassified into class III because multiple patient use blood lancets 
present a potential unreasonable risk of illness or injury and 
insufficient information exists for FDA to determine that special 
controls would provide reasonable assurance of safety and effectiveness 
of the device.
    The June 26, 2013 reclassification Panel recommended that single 
patient blood lancets be reclassified into class II and multiple 
patient blood lancets into class III. The Panel did not believe that 
general controls alone were sufficient to ensure the safety and 
effectiveness of blood lancets. The Panel believed that special 
controls could be established to provide reasonable assurance of the 
safety and effectiveness of single use blood lancets, with and without 
integral sharps injury prevention features, and multiple use lancets 
for single patients, but that special controls could not be established 
to provide reasonable assurance of safety and effectiveness for 
multiple use lancets for multiple patients. Hence, the Panel agreed 
that blood lancets for use on a single patient only should be 
reclassified into class II (special controls), and multiple use lancets 
for multiple patients should be reclassified into class III (premarket 
approval).

VII. Summary of Data Upon Which the Reclassification Is Based

    FDA uses the bloodborne pathogens definition in 29 CFR 
1910.1030(b). Bloodborne pathogens, such as HBV, may be transmitted 
between patients by blood and certain body fluids (Ref. 32). Since HBV-
infected patients, who often lack clinical symptoms of hepatitis, have 
high concentrations of HBV in their blood and HBV is stable at ambient 
temperatures, transmission of HBV may result from exposure to equipment 
that has not been adequately disinfected or by the misuse of ``single 
use only'' medical devices (e.g., needles and syringes) (Ref. 33).
    The history of recognized bloodborne pathogen transmission by blood 
lancets may have started in 1923 when an outbreak of jaundice occurred 
in the Goteborg Hospital diabetic clinic in Sweden, which was described 
by Schmid, et al. (Ref. 10). All patients had blood drawn for glucose 
testing from their ear lobes by a spring-activated ``Schnepper'' 
device, which was cleaned ``perfunctorily'' between uses. As a result, 
26 clinic patients developed jaundice. Outbreaks of hepatitis in 
English diabetic patients were described by Graham in 1938 (Ref. 11) 
and by Droller in 1945 (Ref. 12). In both of these outbreaks, venous 
blood for glucose measurement was drawn using syringes that were only 
chemically disinfected between uses while the needles were boiled; 
cleaning procedures were not mentioned in the reports. Syringes and 
needles are now single-use-only devices because the procedures used to 
reprocess these devices many years ago have long been recognized to be 
inadequate, resulting in outbreaks of hepatitis transmission (Ref. 10). 
There were also two case reports, in 1985 and 1997, of the transmission 
of HBV infection due to sharing personal use blood lancets for home 
glucose monitoring with one other person who already had HBV. One 
report was from the United States and one was from Hungary (Refs. 13 
and 14). In addition, Mendez et al. reported a 75-year-old patient with 
diabetes who died of acute hepatitis, whose only risk factor for HBV 
infection appeared to be her diabetic care at a local outpatient 
facility where she had repeated fingersticks for blood glucose 
monitoring (Ref. 15).
    During the 1990s, several bloodborne pathogen transmission issues 
led to CDC and FDA involvement. In 1990, CDC learned of a nosocomial 
outbreak of HBV transmission due to the use of a spring-loaded lancet 
device whose disposable platform was not removed

[[Page 11145]]

and discarded after each use of the device while it was used for the 
care of multiple patients (Ref. 4).\1\ CDC reported this outbreak to 
FDA; FDA then issued a safety alert warning users of the precautions 
needed for the safe use of this device (Ref. 5). This was the first 
reported outbreak of HBV transmission associated with the use of a 
blood lancet device in the United States (Refs. 5 and 7).
---------------------------------------------------------------------------

    \1\ Hepatitis B and hepatitis C infections, as well as other 
bloodborne infections such as HIV infection, are reported to State 
health departments and, by them, to CDC; FDA does not usually 
receive such reports directly from health care facilities or 
personnel, even when a medical device has transmitted the infection.
---------------------------------------------------------------------------

    CDC's outbreak investigation revealed that a patient who had 
diabetes and also a chronic HBV infection caused by a relatively rare 
viral subtype was admitted to the outbreak ward in 1989. Twelve of the 
23 patients who acquired HBV after admission to the same ward as the 
chronic HBV source patient were serotyped, and all were found to have 
the same viral subtype causing their HBV infections. The first 
nosocomially infected patient had a very long-term stay on the ward and 
so served as a source of transmission to other patients over a period 
of 12 months. Twenty of the 23 outbreak patients had diabetes; they and 
the three other case-patients all experienced numerous POC fingerstick 
blood draws with the same type of blood lancet while hospitalized on 
the outbreak ward. The implicated blood lancet device included a 
disposable platform to stabilize the patient's finger; the single use 
lancet blade penetrated a hole in that platform to reach the patient's 
skin. Half the ward nursing staff who performed fingersticks with this 
lancet acknowledged not changing the device platform with each use of 
the lancet. A similar outbreak of hepatitis transmission was reported 
in 1990 in France in which a similar blood lancet device was 
implicated. Douvin et al. (Ref. 8) reported that examination of the 
device implicated in the French outbreak showed visible blood 
contamination of the lancet platform in 24 percent of studied uses of 
that device. Shier et al. (Ref. 9) reported in 1993 that the use of 
another spring-loaded lancet device in a volunteer study of blood 
glucose levels resulted in visible blood contamination on 29 percent of 
the device end caps. This device was intended for ``personal'' use 
only.
    As a result of the 1990 outbreak of HBV transmission due to blood 
lancet use in the United States, FDA and CDC recommended that spring-
loaded blood lancet devices should have only single use only 
``platforms'' as well as single use only blades; the devices were to be 
cleaned and disinfected per the manufacturer's instructions (Refs. 4 
and 5). The 1990 FDA Safety Alert also advised ``Devices [blood 
lancets] without a removable platform should only be used with one 
patient in the hospital or outpatient setting. After the patient is 
discharged, the device may be reused only if it is disinfected 
according to the manufacturer's instructions. If there are no 
instructions for disinfection, the device should be discarded.''
    Since 1990, the incidence of diabetes mellitus has increased 
significantly in the United States, especially in adults aged 65-79 
(Refs. 34 and 35). At the same time, clinical practice in the care of 
these patients increasingly emphasized the need for improved blood 
glucose level control, resulting in the increased use of POC blood 
glucose monitoring both in health care facilities and at home (Refs. 36 
to 38). Unfortunately, along with the increased incidence of diabetes 
has come a progressive increase in the reports of bloodborne infection 
transmission (primarily HBV), resulting from the shared use of 
fingerstick and POC blood testing devices (Ref. 1). In 2011, the CDC 
reported that 25 of 29 outbreaks of HBV infection occurring in long-
term care facilities since 1996 involved adults with diabetes receiving 
assisted blood glucose monitoring (Ref. 39).
    In 1997, CDC reported two outbreaks of HBV transmission, one in a 
nursing home in Ohio and one in a hospital in New York City (NYC) (Ref. 
16). Two different blood lancet devices were used at the two sites. 
However, both lancet devices included the use of an ``end cap'' that 
came in contact with patient skin. This was a separate, individual use 
component of the lancet device used in Ohio; the nursing home was 
reusing both the lancet and the cap for multiple patients. The end cap 
was a part of the disposable, single use only lancet blade assembly in 
the device used in NYC. The exact mechanism of blood transmission was 
not entirely clear in the NYC setting; staff claimed they had discarded 
the end cap after each use. CDC postulated that either blood-
contaminated nurses gloves worn for the care of multiple patients or 
the pen-like lancet-holding device itself might have been the source of 
the blood cross-contamination of the lancet. A similar outbreak was 
reported by Quale et al. in 1998 from a hospital in New York (Ref. 17). 
The recognition of 3 cases of nosocomially acquired HBV infection 
resulted in an investigation that uncovered another 11 cases. Reuse by 
hospital staff of a disposable lancet end cap with the lancet in 
multiple patients was identified as the probable cause of hepatitis 
cross-transmission to patients; contamination of the lancet wound from 
blood on unchanged gloves worn by nurses during collection of blood 
samples from multiple patients may also have contributed to the 
nosocomial transmission of HBV in this outbreak.
    CDC reviewed the incidence of reported outbreaks of HBV and 
hepatitis C infection in nonhospital health care settings between 1998 
and 2008 and noted a significant increase in such nosocomial 
transmission of bloodborne pathogens (Refs. 18 to 21). N.D. Thompson et 
al. identified 33 outbreaks of nosocomial hepatitis transmission in 
nonhospital health care settings (Ref. 18). Of these 33 outbreaks, 15 
were found to be due to blood glucose monitoring in long-term care 
facilities. Only half of these outbreak investigations were published 
in the scientific literature; the others were recognized by health 
department investigations and reports to CDC. In 9 of the 15 outbreaks 
of nosocomial hepatitis in patients with diabetes, blood lancet devices 
were shared among multiple patients. In two additional outbreaks, 
lancets were not noted to be shared, but blood-soiled glucose meters 
were stored together with lancets without cleaning/disinfection of the 
devices and gloves were not regularly changed between each patient. 
These failures of proper infection control practice could have led to 
blood contamination of individual blood lancets in these two 
facilities.
    N.D. Thompson et al. also investigated blood glucose monitoring 
practices in long-term care facilities in Pinellas County, FL, in 2007 
and found that 22 percent of the participating facilities that used 
reusable fingerstick devices used them in multiple patients (Ref. 22). 
Patel et al. reported in 2009 on the efforts of the Virginia Department 
of Health to improve blood glucose monitoring practices in ALFs in 
Virginia (Ref. 23). This effort followed two separate outbreaks of HBV 
infections in two ALFs. In those outbreaks, one of the three acutely 
symptomatic initial patients died of HBV infection. Of 68 patients 
undergoing blood glucose monitoring in these 2 facilities, a total of 
11 patients acquired HBV infection. Both facilities used reusable blood 
lancets to obtain blood from multiple patients and did not clean or 
disinfect them between uses. The Virginia Department of Health then 
mailed an educational packet on safe blood glucose monitoring practices 
to all ALFs (640) in the State. A random sample of

[[Page 11146]]

ALFs was contacted after the educational intervention and invited to 
participate in a survey to evaluate the response to the educational 
packet. The results found that 16 percent of the facilities that used 
lancets to monitor blood glucose levels were still using these devices 
to obtain blood from multiple patients.
    Y.G. McIntosh et al. investigated outbreaks of nosocomial HBV 
transmission in four ALFs between 2009 and 2011 and found that in all 
four facilities, pen-style lancets were used to obtain blood for 
glucose monitoring from multiple patients even though two facilities 
provided each patient with dedicated ``single patient use only pen-
style lancets'' according to their policies (Ref. 24). Z. Moore et al. 
reported another outbreak of nosocomial HBV transmission in an ALF in 
North Carolina in 2010 in which blood lancet devices were shared among 
multiple patients. Six of the eight elderly patients who acquired acute 
HBV in this outbreak died from complications of hepatitis (Ref. 25). 
M.K. Schaefer et al. surveyed a stratified, random sample of ambulatory 
surgery centers (ASCs) in three volunteer states in 2009 (Ref. 26). Of 
the 53 ASCs that performed blood glucose monitoring, 11 (21 percent) 
reused pen-style blood lancets on multiple patients and 17 (32 percent) 
also failed to clean and disinfect blood glucose meters after each use.
    Thompson and Schaefer reported the analysis of four outbreaks of 
nosocomial HBV in ALFs in 2009-2010 (Ref. 27). One was also reported 
separately by Z. Moore et al. (Ref. 24). Two of the three other 
outbreaks occurred in Virginia and one in Florida; these 3 outbreaks 
resulted in 21 new patients acquiring acute HBV. In two of the three 
facilities, use of reusable blood lancets to draw blood from multiple 
patients was observed or reported. The third facility denied that it 
permitted the sharing of reusable lancets. However, used lancets and 
glucose meters were stored together, along with clean supplies; visible 
blood contamination was observed on several glucose meters and one 
reusable lancet by the investigator. Thompson and Schaefer also 
reported in their paper on two patient notification campaigns resulting 
from the misuse of reusable blood lancets with preloaded lancet 
cartridges, intended and cleared only for single patient use, which 
were used to obtain blood from multiple patients. One episode involved 
a community health center and was reported when personnel noted that 
the lancet blades were not retracting properly, which might have 
resulted in blade use for more than one patient. The second episode 
occurred at a community health fair in which physician assistant 
students were offering diabetes screening. During the fair, the 
students realized that the lancet blades had not been advanced properly 
so that each patient received a new blade. The first episode exposed 
283 patients to a contaminated lancet blade; the second incident 
exposed approximately 60 patients. The results of the patient 
notification studies were not reported.
    As a result of this significant increase in such nosocomial 
transmission of bloodborne pathogens, on August 26, 2010, FDA and the 
CDC issued a Safety Communication (Ref. 1) and a Clinical Reminder 
(Ref. 6), respectively, warning that the use of blood lancets to obtain 
blood from more than one patient risks the transmission of bloodborne 
pathogen infections from one patient to other patients. Both FDA and 
CDC recommended that blood lancets should never be used to obtain blood 
from more than one patient. In addition, the Centers for Medicare and 
Medicaid Services issued a Survey and Certification Memorandum for 
Point of Care Devices and Infection Control in Nursing Homes 
identifying the use of blood lancet devices for more than one patient 
as an infection control standards deficiency (Ref. 40). On November 29, 
2010, FDA issued ``Guidance for Industry and Food and Drug 
Administration Staff: Blood Lancet Labeling,'' which provided guidance 
for lancet manufacturers on the labeling of all blood lancets, 
including those capable of reuse, as ``single patient use only'' 
devices (Ref. 2).
    In 2012, another outbreak of acute HBV was reported in an ALF in 
Virginia (Ref. 28). The source patient had been recently transferred 
from another ALF where she had acquired nosocomial HBV infection from 
the shared use of blood lancets for multiple patients (Ref. 24). This 
ALF also reused blood lancets to obtain blood from multiple patients 
for glucose monitoring. This dangerous practice resulted in two new 
nosocomial HBV infections in this ALF.
    Outbreaks of hepatitis transmission due to use of blood lancets to 
draw blood from more than one patient for blood glucose monitoring have 
not been limited to the United States. In 2001, Desenclos et al. 
described an outbreak of nosocomial hepatitis C transmission in an 
inpatient ward for children with cystic fibrosis and diabetes in a 
French hospital in 1994-1995 (Ref. 29). Blood glucose monitoring was 
done by the nursing staff for the patients with cystic fibrosis as well 
as for the patients with diabetes using a spring-loaded lancet with a 
disposable platform to stabilize the finger. These devices were shared 
among patients between 1986 and 1992 during repeated admissions to the 
inpatient unit. After 1992, patients were supposed to use only their 
own lancet devices for blood glucose monitoring. The retrospective 
prevalence of prior hepatitis C infection was found to be 58 percent in 
patients with cystic fibrosis and 17 percent in patients with diabetes 
in 1994. At the time (1994), the prevalence of antibody to hepatitis C 
in the general public in France was 1.1 percent. The patients with 
cystic fibrosis had more frequent and longer admissions to the 
inpatient ward and more of the exposed cystic fibrosis patients (66.7 
percent) were screened for hepatitis C infection than were the patients 
with diabetes admitted to the inpatient ward during the exposure period 
(39.5 percent). These factors may have influenced the apparent 
difference in hepatitis C transmission in these two groups of exposed 
patients.
    In 2005, De Schrijver et al. described an outbreak of acute HBV 
infection in a nursing home in Antwerp (Ref. 30). The initial report of 
a fulminant case of acute HBV infection in an 83-year-old resident of 
the home resulted in an investigation that identified acute HBV 
infection in another four patients there. Four of the five acutely 
infected patients had diabetes and received assisted blood glucose 
sampling by the nursing home staff. The two blood lancet models used in 
the facility (one each in two sections) were used to obtain blood from 
multiple patients. The device platforms were not disposable. The 
lancets were washed only when blood was visible on the device and they 
were not disinfected. Nurses did not routinely wash their hands or wear 
gloves when obtaining blood. Two of the five patients with acute 
nosocomial HBV died of their infections.
    In 2008, Gotz et al. reported the investigation of two cases of 
acute HBV infection among patients at a nursing home in the Netherlands 
(Ref. 31). The nursing home stay of these two patients overlapped with 
that of a patient with known chronic HBV infection. Early in this time 
period, the nursing home changed the lancet device used for glucose 
monitoring from a spring-loaded device with a disposable platform (used 
for multiple patients) to a device with a rotating drum dispensing new 
lancet blades, which was also used to draw blood from multiple 
patients, although it was labeled for single patient use only. This 
device was used for about a month until the staff realized that active 
rotation of the drum was occasionally forgotten, resulting in the reuse 
of a lancet blade on more than one patient.

[[Page 11147]]

The new device was then removed from the facility and the spring-loaded 
lancet was returned to use. The two patients with acute HBV received 
blood glucose monitoring as did the source patient with chronic HBV, 
sometimes on the same day. Two other patients who also received blood 
glucose monitoring escaped infection. The investigators stated that 
they believed the rotating lancet drum device was likely the means of 
transmission of HBV infection between patients.
    In 2011, Duffell et al. reported on the investigations of five 
reports of HBV transmission in community health care settings in the 
United Kingdom (Ref. 32). All of the nine initially reported patients 
with HBV had diabetes and were receiving blood glucose monitoring. 
Further investigation identified another 12 patients with acute HBV 
infection. The care settings in which hepatitis transmission occurred 
were described as a ``private residential home'' (one patient), 
``nursing and residential home'' (one patient), ``private nursing and 
residential home'' (one patient) and ``local care home'' (two 
patients). Eleven of the 21 acutely infected patients had symptomatic 
HBV; 7 of these patients died, 5 due to the HBV infection. All of the 
care sites in which acute HBV transmission occurred were using blood 
lancets intended for single patient use only; these devices were either 
routinely or occasionally used for multiple patients. One facility also 
used a single glucometer for multiple patients and did not clean or 
disinfect it between patients. The authors also noted that information 
reported on patients found to have acute HBV infection between 1990 and 
2003 identified only four patients with blood glucose monitoring as a 
possible risk factor; one of these patients was infected as a result of 
in-hospital transmission from another patient on the same ward, 
although details were not provided. Between 2004 and 2006, the 9 
patients described previously in this document were reported and 
investigation led to the discovery of an additional 12 cases of health 
care-related HBV transmission due to the improper use of blood lancets 
during patient blood glucose monitoring.

VIII. Special Controls

    FDA believes that the special controls identified in the paragraphs 
that follow--in addition to general controls--are necessary to provide 
reasonable assurance of safety and effectiveness for this device when 
it is for single patient use only. Special controls were discussed at 
the June 26, 2013, reclassification Panel (Ref. 3). The Panel agreed 
that the special controls as presented would provide a reasonable 
assurance of safety and effectiveness for these devices, emphasizing in 
discussions the need for adequate labeling for these devices. FDA 
believes that the special controls proposed for single use only blood 
lancets with an integral sharps injury prevention feature in Sec.  
878.4850(a)(2), in addition to the general controls, mitigate the risks 
to health discussed in section V and are necessary to provide 
reasonable assurance of safety and effectiveness.
    Table 1 depicts how each risk to health would be mitigated by the 
proposed special controls.

 Table 1--Health Risks and Mitigation Measures for Single Use Only Blood
        Lancet With an Integral Sharps Injury Prevention Feature
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Bloodborne pathogen transmission.......  Design characteristics.
                                         Mechanical performance testing.
                                         Labeling.
Sharp object injuries..................  Design characteristics.
                                         Mechanical performance testing.
                                         Labeling.
Local tissue infection.................  Labeling.
                                         Sterilization.
Adverse tissue reaction (not infection)  Biocompatibility.
------------------------------------------------------------------------

    FDA believes that the special controls proposed for single use only 
blood lancets without an integral sharps injury prevention feature in 
proposed in Sec.  878.4850(b)(2), in addition to the general controls, 
mitigate these risks to health discussed in section V and are necessary 
to provide reasonable assurance of safety and effectiveness.
    Table 2 depicts how each risk to health would be mitigated by the 
proposed special controls.

 Table 2--Health Risks and Mitigation Measures for Single Use Only Blood
       Lancet Without an Integral Sharps Injury Prevention Feature
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Bloodborne pathogen transmission.......  Design characteristics.
                                         Mechanical performance testing.
                                         Labeling.
Sharp object injuries..................  Design characteristics.
                                         Mechanical performance testing.
                                         Labeling.
Local tissue infection.................  Labeling.
                                         Sterilization.
Adverse tissue reaction (not infection)  Biocompatibility.
------------------------------------------------------------------------

[[Page 11148]]

    FDA believes that the special controls proposed for multiple use 
blood lancets for single patient use only in proposed Sec.  
878.4850(c)(2), in addition to the general controls, mitigate these 
risks to health discussed in section V and are necessary to provide 
reasonable assurance of safety and effectiveness.
    Table 3 depicts how each risk to health would be mitigated by the 
proposed special controls.

  Table 3--Health Risks and Mitigation Measures for Multiple Use Blood
                   Lancet for Single Patient Use Only
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Bloodborne pathogen transmission.......  Design characteristics.
                                         Mechanical performance testing.
                                         Labeling.
Sharp object injuries..................  Design characteristics.
                                         Mechanical performance testing.
                                         Labeling.
Local tissue infection.................  Labeling.
                                         Sterilization.
                                         Validated cleaning and
                                          disinfection.
Adverse tissue reaction (not infection)  Biocompatibility.
------------------------------------------------------------------------

IX. The Proposed Order

    FDA is issuing this proposed order to reclassify the following 
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 review: (1) Single use only blood lancets with an 
integral sharps injury prevention feature, (2) single use only blood 
lancets without an integral sharps injury prevention feature, and (3) 
multiple use blood lancets for single patient use only. FDA is 
identifying proposed special controls for these types of blood lancets, 
as identified in section VIII of this document, that are necessary to 
provide a reasonable assurance of safety and effectiveness. FDA is also 
proposing to reclassify multiple use blood lancets for multiple patient 
use from class I (general controls) exempt from premarket notification 
into class III (premarket approval).

X. Effective Date

    FDA proposes that any final order based on this draft order become 
effective on its date of publication in the Federal Register.
     Blood lancets for single patient use only that have not 
been offered for sale prior to the effective date of the final order, 
or have been offered for sale but are required to submit a new 510(k) 
under 21 CFR 807.81(a)(3): Manufacturers would have to obtain 510(k) 
clearance before marketing their devices after the effective date of 
the order. If a manufacturer markets such a device without receiving 
510(k) clearance, then FDA would consider taking action against such a 
manufacturer under its usual enforcement policies.
     Blood lancets for single patient use only that have been 
offered for sale prior to the effective date of the final order, and do 
not already have 510(k) clearance: FDA does not intend to enforce 
compliance with the 510(k) requirement or special controls until 180 
days after the effective date of the final order. After that date, if a 
manufacturer continues to market such a device but does not have 510(k) 
clearance or FDA determines that the device is not substantially 
equivalent or not compliant with special controls, then FDA would 
consider taking action against such manufacturer under its usual 
enforcement policies.
    For 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 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 be stated in the 
publically available 510(k) Summary posted in this database. Since 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 
applicable special controls. Elsewhere in this issue of the Federal 
Register, FDA is proposing to require the filing of a PMA or notice of 
completion of a PDP for multiple use blood lancets for multiple patient 
use, which will be finalized only if FDA reclassifies these devices 
into class III.

XI. 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.

XII. Paperwork Reduction Act of 1995

    This proposed order refers to previously approved information 
collections found in FDA regulations. 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 801 have been 
approved under OMB control number 0910-0485. 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 814, 
subparts B and E, have been approved under OMB control number 0910-
0231.
    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 
discarded safely 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.'';

[[Page 11149]]

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)).

XIII. 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, 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), as 
amended by FDASIA, in the proposed order, we are proposing to revoke 
the requirements in Sec.  878.4800 related to the classification of 
blood lancets as class I devices and to codify the reclassification of 
subsets of blood lancets into class II or class III in Sec.  878.4850.

XIV. References

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

1. U.S. Food and Drug Administration (FDA), ``Use of Fingerstick 
Devices on More Than One Person Poses Risk for Transmitting 
Bloodborne Pathogens: Initial Communication'' (August 26, 2010) and 
``Update'' (November 29, 2010), available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm234889.htm and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
2. U.S. Food and Drug Administration, ``Guidance for Industry and 
Food and Drug Administration Staff: Blood Lancet Labeling'' 
(November 29, 2010), available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm234577.htm.
3. FDA's General and Plastic Surgery Devices Panel transcript and 
other meeting materials for the June 26, 2013, meeting are available 
on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm349426.htm.
4. Centers for Disease Control and Prevention (CDC). ``Nosocomial 
Transmission of Hepatitis B Virus Associated With a Spring-Loaded 
Fingerstick Device--California'', MMWR Morbidity and Mortality 
Weekly Report, 1990; 39 (35):610-613. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00001743.htm)
5. Food and Drug Administration (FDA), ``Safety Alert Medical 
Devices; Hepatitis B Transmission via Spring-Loaded Lancet Devices'' 
(August 28, 1990), available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm241809.htm.
6. Centers for Disease Control and Prevention (CDC), ``CDC Clinical 
Reminder Use of Fingerstick Devices on More Than One Person Poses 
Risk for Transmitting Bloodborne Pathogens'', available at http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
7. Polish, L., C. Shapiro, F. Bauer, et al., ``Nosocomial 
Transmission of Hepatitis B Virus Associated With the Use of a 
Spring-Loaded Fingerstick Device'', New England Journal of Medicine, 
1992; 326 (11):721-725.
8. Douvin, C., D. Simon, H. Zinelabidine, et al., ``An Outbreak of 
Hepatitis B in an Endocrinology Unit Traced to a Capillary Blood 
Sampling Device'', New England Journal of Medicine, 1990; 322:57-58.
9. Shier, N., J. Warren, M. Torabi, et al., ``Contamination of a 
Fingerstick Device'', New England Journal of Medicine, 1993; 
328:969-970.
10. Schmid, R., ``History of Viral Hepatitis: A Tale of Dogmas and 
Misinterpretations'', Journal of Gastroenterology and Hepatology, 
2001; 16(7):718-722.
11. Graham, G., ``Diabetes Mellitus: A Survey of Changes in 
Treatment During the Last Fifteen Years'', The Lancet, 1938 2:1-7.
12. Droller, H., ``An Outbreak of Hepatitis in a Diabetic Clinic'', 
British Medical Journal, 1945; 1(4400):623-625.
13. Stapleton, J., and S. Lemon, ``Transmission of Hepatitis B 
During Blood Glucose Monitoring'', Journal of the American Medical 
Association 1985; 253:3250.
14. Farkas K and G Jermendy. ``Transmission of Hepatitis B Infection 
During Home Blood Glucose Monitoring'', Diabetic Medicine, 1997; 
14:263.
15. Mendez, L., K.R. Reddy, R.A. Di Prima, et al., ``Fulminant 
Hepatic Failure Due to Acute Hepatitis B and Delta Co-Infection: 
Probable Bloodborne Pathogen Transmission Associated With a Spring-
loaded Fingerstick Device'', American Journal of Gastroenterology, 
1991; 86:895-897.
16. Centers for Disease Control and Prevention (CDC), ``Nosocomial 
Hepatitis B Virus Infection Associated With Reusable Fingerstick 
Blood Sampling Devices--Ohio and New York City, 1996'', MMWR 
Morbidity and Mortality Weekly Report, 1997; 46(10):217-221. 
(Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00046679.htm.)
17. Quale, J.M., D. Landman, B. Wallace, et al., 
``D[eacute]j[agrave] vu: Nosocomial Hepatitis B Transmission and 
Fingerstick Monitoring'', The American Journal of Medicine, 1998; 
105;296-301.
18. Thompson, N.D., J. Perz, A. Moorman, et al., ``Nonhospital 
Health Care-Associated Hepatitis B and C Virus Transmission: United 
States, 1998-2008'', Annals of Internal Medicine, 2009; 150:33-39.
19. Khan, A.J., S.M. Cotter, B. Schulz, et al., ``Nosocomial 
Transmission of Hepatitis B Virus Infection Among Residents With 
Diabetes in a Skilled Nursing Facility'', Infection Control and 
Hospital Epidemiology, 2002; 23:313-318.
20. Centers for Disease Control and Prevention (CDC), ``Transmission 
of Hepatitis B Virus Among Persons Undergoing Blood Glucose 
Monitoring in Long-Term-Care Facilities--Mississippi, North 
Carolina, and Los Angeles County, California, 2003-2004'', MMWR 
Morbidity and Mortality Weekly Report, 2005; 54(09):220-223. 
(Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5409a2.htm.)
21. Thompson, N.D. and J.F. Perz, ``Eliminating the Blood: Ongoing 
Outbreaks of Hepatitis B Virus Infection and the Need for Innovative 
Glucose Monitoring Techniques'', Journal of Diabetes Science and 
Technology, 2009; 3(2):283-288.
22. Thompson, N.D., V. Barry, K. Alelis, et al., ``Evaluation of the 
Potential for Bloodborne Pathogen Transmission Associated With 
Diabetes Care Practices in Nursing Homes and Assisted Living 
Facilities, Pinellas County'', Journal of the American Geriatrics 
Society, 2010; 58:914-918.
23. Patel, A.S., M.B. White-Comstock, D. Woolard, et al., 
``Infection Control Practices in Assisted Living Facilities: A 
Response to Hepatitis B Virus Infection Outbreaks'', Infection 
Control and Hospital Epidemiology, 2009; 30:209-214.
24. Centers for Disease Control and Prevention (CDC), ``Multiple 
Outbreaks of Hepatitis B Virus Infection Related to Assisted 
Monitoring of Blood Glucose Among Residents of Assisted Living 
Facilities--Virginia, 2009-2011'', MMWR Morbidity and Mortality 
Weekly Report, 2012; 61(19):339-343. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6119a3.htm?s_cid=mm6119a3_w.)
25. Centers for Disease Control and Prevention (CDC), ``Notes From 
the Field: Deaths From Acute Hepatitis B Virus Infection Associated 
With Assisted Blood Glucose Monitoring in an Assisted-Living 
Facility--North

[[Page 11150]]

Carolina, August-October, 2010'', MMWR Morbidity and Mortality 
Weekly Report, 2011; 60(6):182. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6006a5.htm?s_cid=mm6006a5_w.)
26. Schaefer, M.K., M. Jhung, M. Dahl, et al., ``Infection Control 
Assessment of Ambulatory Surgical Centers'', Journal of the American 
Medical Association, 2010; 303 (22):2273-2279.
27. Thompson, N.D. and M.K. Schaeffer, ```Never Events': Hepatitis B 
Outbreaks and Patient Notifications Resulting From Unsafe Practices 
During Assisted Monitoring of Blood Glucose, 2009-2010'', Journal of 
Diabetes Science and Technology, 2011; 5(6):1396-1402.
28. Centers for Disease Control and Prevention (CDC), ``Notes From 
the Field: Transmission of HBV Among Assisted-Living-Facility 
Residents--Virginia, 2012'', MMWR Morbidity and Mortality Weekly 
Report, 2013; 62(19):389. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6219a4.htm?s_cid=mm6219a4_w.)
29. Desenclos, J.C., M. Bourdiol-Razes, B. Rolin, et al., 
``Hepatitis C in a Ward for Cystic Fibrosis and Diabetic Patients: 
Possible Transmission by Spring-Loaded Finger-Stick Devices for 
Self-Monitoring of Capillary Blood Glucose'', Infection Control and 
Hospital Epidemiology, 2001; 22(11):701-707.
30. De Schrijver, K., I. Maes, P. Van Damme, et al., ``An Outbreak 
of Nosocomial Hepatitis B Virus Infection in a Nursing Home for the 
Elderly in Antwerp (Belgium)'', Acta Clinica Belgica, 2005; 
60(2):63-69.
31. Gotz, H.M., M. Schutten, G.J. Borsboom, et al., ``A Cluster of 
Hepatitis B Infections Associated With Incorrect Use of a Capillary 
Blood Sampling Device in a Nursing Home in the Netherlands, 2007'', 
Euro Surveillance, 2008; 13(7-9):1-5.
32. Duffell, E.F., L.M. Milne, C. Seng, et al., ``Five Hepatitis B 
Outbreaks in Care Homes in the UK Associated With Deficiencies in 
Infection Control Practice in Blood Glucose Monitoring'', 
Epidemiology and Infection, 2011; 139:327-335.
33. Williams, I.T., J.F. Perz, and B.P. Bell, ``Viral Hepatitis 
Transmission in Ambulatory Health Care Settings'', Clinical 
Infectious Diseases, 2004; 38(11):1592-1598.
34. Centers for Disease Control and Prevention (CDC), ``Increasing 
Prevalence of Diagnosed Diabetes--United States and Puerto Rico, 
1995-2010'', MMWR Morbidity and Mortality Weekly Report, 2012; 
61(45):918-921. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6145a4.htm?s_cid=mm6145a4_w.)
35. Centers for Disease Control and Prevention (CDC), ``Incidence of 
Diagnosed Diabetes per 1,000 Population Aged 18-79 Years, by Age, 
1980-2014'', Atlanta, GA: U.S. Department of Health and Human 
Services, CDC, National Diabetes Surveillance System. Available at 
www.cdc.gov/diabetes/statistics/incidence/fig3.htm. Accessed October 
19, 2014.
36. Clarke, S.F. and J.R. Foster, ``A History of Blood Glucose 
Meters and Their Role in Self-Monitoring of Diabetes Mellitus'', 
British Journal of Biomedical Science, 2012; 69(2):83-93.
37. Yoo, E.-H. and S.-Y. Lee, ``Glucose Biosensors: An Overview of 
Use in Clinical Practice'', Sensors, 2010; 10(5):4558-4576.
38. Rajendran, R. and G. Rayman, ``Point-of-Care Blood Glucose 
Testing for Diabetes Care in Hospitalized Patients: An Evidence-
Based Review'', Journal of Diabetes Science and Technology, 2014; 
8(6):1081-1090.
39. Centers for Disease Control and Prevention (CDC), ``Use of 
Hepatitis B Vaccination for Adults With Diabetes Mellitus: 
Recommendations of the Advisory Committee on Immunization Practices 
(ACIP)'', MMWR Morbidity and Mortality Weekly Report, 2011; 
60(50):1709-1711. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a4.htm?s_cid=mm6050a4_w.)
40. Centers for Medical Services (CMS), ``Survey and Certification 
Memorandum'' (August 27, 2010), available at http://www.cms.gov/surveycertificationgeninfo/downloads/SCLetter10_28.pdf.

List of Subjects in 21 CFR Part 878

    Medical devices.

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

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR 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 subchapter.
* * * * *
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 the 
device;
    (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 cleaning and 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 11151]]

    (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 the 
device;
    (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 cleaning and 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 the 
device;
    (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 cleaning and 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: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04578 Filed 3-2-16; 8:45 am]
BILLING CODE 4164-01-P