Document ID: FDA-2016-M-0035-0001
Agency: fda
Document Type: Proposed Rule
Title: Effective Date of Requirement for Premarket Approval for Blood Lancets
Posted Date: 2016-03-03T05:00Z

[Federal Register Volume 81, Number 42 (Thursday, March 3, 2016)]
[Proposed Rules]
[Pages 11151-11160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04579]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2016-M-0035]

Effective Date of Requirement for Premarket Approval for Blood 
Lancets

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed 
administrative order to require the filing of a premarket approval 
application (PMA) following the reclassification of multiple use blood 
lancets for multiple patient use from class I to class III. FDA is 
summarizing its proposed findings regarding the degree of risk of 
illness or injury designed to be eliminated or reduced by requiring 
this device to meet the PMA requirements of the Federal Food, Drug,

[[Page 11152]]

and Cosmetic Act (the FD&C Act) and the benefits to the public from the 
use of the device.

DATES: Submit either electronic or written comments on this proposed 
order by June 1, 2016. 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 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-M-0035 for ``Effective Date of Requirement for Premarket 
Approval for 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.

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, 
joshua.nipper@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The FD&C Act, as amended, establishes a comprehensive system for 
the regulation of medical devices intended for human use. Section 513 
of the FD&C Act (21 U.S.C. 360c) established three categories (classes) 
of devices, reflecting the regulatory controls needed to provide 
reasonable assurance of their safety and effectiveness. The three 
categories of devices are class I (general controls), class II (special 
controls), and class III (premarket approval).
    Under section 513(d)(1) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the 1976 amendments, 
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 prior to 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 device that does not require 
premarket approval. The Agency determines whether new devices are 
substantially equivalent to predicate devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and 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, and devices 
found substantially equivalent by means of premarket notification 
(510(k)) procedures to such a preamendments device or to a device 
within that type (both the preamendments and substantially equivalent 
devices are referred to as preamendments class III devices) may be 
marketed 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. Section 515(b)(1) of the FD&C Act directs FDA to 
issue an order requiring premarket approval for a preamendments class 
III device.
    Section 515(f) of the FD&C Act provides an alternative pathway for 
meeting the premarket approval

[[Page 11153]]

requirement. Under section 515(f), manufacturers may meet the premarket 
approval requirement if they file a notice of completion of a product 
development protocol (PDP) approved under section 515(f)(4) of the FD&C 
Act and FDA declares the PDP completed under section 515(f)(6)(B) of 
the FD&C Act. Accordingly, the manufacturer of a class III 
preamendments device may comply with a call for PMAs by filing a PMA or 
a notice of completion of a PDP. In practice, however, the option of 
filing a notice of completion of a PDP has rarely been used. For 
simplicity, although the PDP option remains available to manufacturers 
in response to a final order under section 515(b) of the FD&C Act, this 
document will refer only to the requirement for the filing and 
obtaining approval of a PMA.
    On July 9, 2012, Congress enacted the Food and Drug Administration 
Safety and Innovation Act (FDASIA). Section 608(b) of FDASIA (126 Stat. 
1056) amended section 515(b) of the FD&C Act, changing the process for 
requiring premarket approval for a preamendments class III device from 
rulemaking to an administrative order.
    Section 515(b)(1) of the FD&C Act sets forth the process for 
issuing a final order. Specifically, prior to the issuance of a final 
order requiring premarket approval for a preamendments class III 
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.
    In June 2013, FDA held a meeting of a device classification panel 
described in section 513(b) of the FD&C Act to discuss the 
classification of multiple use blood lancets for multiple patient use. 
Although, to FDA's knowledge, no device is currently being marketed for 
this use, one device has been cleared for this use. As explained 
further in section V.A of this document, this device classification 
panel meeting discussed whether multiple use blood lancets for multiple 
patient use should be reclassified into class III or remain in class I, 
and the discussion included whether PMAs should be required for these 
devices. The panel recommended that, 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, the device should be reclassified into class III. FDA is not aware 
of new information that would provide a basis for a different 
recommendation or findings.
    Section 515(b)(2) of the FD&C Act provides that a proposed order to 
require premarket approval shall contain: (1) The proposed order, (2) 
proposed findings with respect to the degree of risk of illness or 
injury designed to be eliminated or reduced by requiring the device to 
have an approved PMA and the benefit to the public from the use of the 
device, (3) an opportunity for the submission of comments on the 
proposed order and the proposed findings, and (4) an opportunity to 
request a change in the classification of the device based on new 
information relevant to the classification of the device.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after 
the close of the comment period on the proposed order, consideration of 
any comments received, and a meeting of a device classification panel 
described in section 513(b) of the FD&C Act, issue a final order to 
require premarket approval or publish a document terminating the 
proceeding together with the reasons for such termination. If FDA 
terminates the proceeding, FDA is required to initiate reclassification 
of the device under section 513(e) of the FD&C Act, unless the reason 
for termination is that the device is a banned device under section 516 
of the FD&C Act (21 U.S.C. 360f).
    A preamendments class III device may be commercially distributed 
without a PMA until 90 days after FDA issues a final order requiring 
premarket approval for the device, or 30 months after final 
classification of the device under section 513 of the FD&C Act becomes 
effective, whichever is later (section 501(f) of the FD&C Act (21 
U.S.C. 351(f)). Elsewhere in this issue of the Federal Register, FDA is 
issuing a proposed order to reclassify multiple use blood lancets for 
multiple patient use from class I to class III. Therefore, assuming 
both the reclassification order and the order to require PMAs are 
finalized at the same time, the date by which a PMA for multiple use 
blood lancets for multiple patient use must be filed will be 30 months 
after the date FDA issues the final order reclassifying multiple use 
blood lancets for multiple patients. If a PMA is not filed for such 
device by the later of the two dates, as specified in section 
501(f)(2)(B) of the FD&C Act, then the device would be deemed 
adulterated under section 501(f) of the FD&C Act unless the device is 
distributed for investigational use under an approved application for 
an investigational device exemption (IDE).
    In accordance with section 515(b) of the FD&C Act, interested 
persons are being offered the opportunity to request reclassification 
of multiple use blood lancets for multiple patient use.

II. Regulatory History of the Device

    Elsewhere in this issue of the Federal Register, FDA is proposing 
to reclassify multiple use blood lancets for multiple patient use into 
class III under section 513(e) of the FD&C Act.
    Blood lancets were classified in part 878 (21 CFR part 878) by 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,'' 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. 
This 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 joint initial communications 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 the FDA have noted a progressive increase in reports 
of bloodborne infection transmission (primarily hepatitis B virus) 
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

[[Page 11154]]

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, 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 blood lancets. 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 finding.

III. Dates New Requirements Apply

    Assuming FDA finalizes the order proposing reclassification of 
multiple use blood lancets for multiple patient use found elsewhere in 
this issue of the Federal Register, this device will be classified into 
class III. In accordance with sections 501(f)(2)(B) and 515(b) of the 
FD&C Act, FDA is proposing to require that a PMA be filed with the 
Agency for multiple use blood lancets for multiple patient use devices 
and accessories by the last day of the 30th calendar month beginning 
after the month in which the classification of the device in class III 
became effective, or on the 90th day after the date of the issuance of 
a final order under 515(b), whichever is later. Assuming this order is 
finalized at or near the same time the final order to reclassify these 
devices into class III, this requirement will take effect 30 months 
after the reclassification order issues. An applicant whose device was 
legally in commercial distribution before May 28, 1976, or whose device 
has been found to be substantially equivalent to such a device, will be 
permitted to continue marketing such class III devices during FDA's 
review of the PMA provided that a PMA is timely filed. FDA intends to 
review any PMA for the device within 180 days. FDA cautions that under 
section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into 
an agreement to extend the review period for a PMA beyond 180 days 
unless the Agency finds that ``. . . the continued availability of the 
device is necessary for the public health.''
    Under the FD&C Act, if any multiple use blood lancets for multiple 
patient use are currently in distribution and no PMA is submitted for 
these devices by the last day of the 30th calendar month beginning 
after the month in which the classification of the device in class III 
became effective or within 90 days of a final order calling for PMAs, 
or a denial is rendered on a filed PMA, these devices would be 
considered adulterated under section 501(f)(1) of the FD&C Act. In 
addition, no new devices will be permitted in interstate commerce 
without approval of a PMA. The device may be distributed for 
investigational use only if the requirements of the IDE regulations are 
met. The requirements for significant risk devices include submitting 
an IDE application to FDA for review and approval. An approved IDE is 
required to be in effect before an investigation of the device may be 
initiated or continued under Sec.  812.30 (21 CFR 812.30). FDA, 
therefore, recommends that IDE applications be submitted to FDA at 
least 30 days before the end of the 30-month period after the issuance 
of the final order to avoid interrupting any ongoing investigations.
    FDA intends that under Sec.  812.2(d), the publication in the 
Federal Register of any final order based on this proposal will include 
a statement that, as of the date on which the filing of a PMA is 
required, the exemptions in Sec.  812.2(c)(1) and (2) from the 
requirements of the IDE regulations for preamendments class III devices 
will cease to apply to any device that is: (1) Not legally on the 
market on or before that date, or (2) legally on the market on or 
before that date but for which a PMA is not filed by that date, or for 
which PMA approval has been denied or withdrawn.

IV. Device Subject to This Proposal

Multiple Use Blood Lancet for Multiple Patient Use (21 CFR 878.4850(d))

    Elsewhere in this issue of the Federal Register, FDA is proposing 
to identify multiple use blood lancet for multiple patient use in a new 
21 CFR 878.4850(d) in the following way: 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.

V. Proposed Findings With Respect to Risks and Benefits Multiple Use 
Blood Lancet for Multiple Patient Use

    As required by section 515(b) of the FD&C Act, FDA is publishing 
its proposed findings regarding: (1) The degree of risk of illness or 
injury designed to be eliminated or reduced by requiring that this 
device have an approved PMA, and (2) the benefits to the public from 
the use of the device.
    These findings are based on the reports and recommendations of the 
General and Plastic Surgery Devices Panel of the Medical Devices 
Advisory Committee (the Panel) from the meeting on June 26, 2013 (Ref. 
3) and any additional information that FDA has obtained. Additional 
information regarding the risks as well as classification associated 
with this device type can be found in section V.C as well as in the 
proposed order published elsewhere in this issue of the Federal 
Register proposing to reclassify these devices into class III. The 
device has the potential to benefit the public by puncturing the skin 
to obtain small blood specimens for testing blood glucose, hemoglobin, 
and other blood components. In addition, acute care hospitals may 
consider reusing a single device or using one device with multiple 
blades to have benefits in that doing so may expedite procedures. The 
risks associated with the device include bloodborne pathogen 
transmission, sharp object injuries, local tissue infections, and 
adverse tissue reaction (not infection).

A. Summary of Data

    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. 4).

[[Page 11155]]

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. 5).
    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. 6). 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. 7) and 
by Droller in 1945 (Ref. 8). 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. 6). 
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. 9 and 
10). 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. 11).
    During the 1990s, several bloodborne 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 and discarded after each use of the 
device while it was used for the care of multiple patients (Ref. 
12).\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. 13). This was the first reported outbreak of HBV 
transmission associated with the use of a blood lancet device in the 
United States (Refs. 13 and 14).
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    \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.
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    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 hepatitis B 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 hepatitis B 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. 15) 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. 16) 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. 12 
and 13). 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. 17 and 18). 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. 
19-21). 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 
blood glucose monitoring (Ref. 22).
    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. 
23). 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. 24). 
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

[[Page 11156]]

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. 25-28). N.D. Thompson et 
al. identified 33 outbreaks of nosocomial hepatitis transmission in 
nonhospital health care settings (Ref. 25). Of these 33 outbreaks, 15 
were found to be due to blood glucose monitoring in long-term care and 
assisted living 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, Florida, in 
2007 and found that 22 percent of the participating facilities that 
used reusable fingerstick devices used them in multiple patients (Ref. 
29). Patel et al. reported in 2009 on the efforts of the Virginia 
Department of Health to improve blood glucose monitoring practices in 
assisted living facilities (ALFs) in Virginia (Ref. 30). This effort 
followed two separate outbreaks of HBV infections in two assisted 
living facilities. In those outbreaks, one of the three acutely 
symptomatic initial patients died of HBV infection. Of 68 patients 
undergoing blood glucose monitoring in these two 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 the lancets 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 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. 31). Z. Moore et al. 
reported another outbreak of nosocomial HBV transmission in an ALF in 
NC 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. 32). M.K. 
Schaefer et al. surveyed a stratified, random sample of ambulatory 
surgery centers (ACS) in three volunteer states in 2009 (Ref. 33). Of 
the 53 ACS 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. 34). One was also reported 
separately by Z. Moore et al. (Ref. 32). Two of the three other 
outbreaks occurred in Virginia and one in Florida; these 3 outbreaks 
resulted in 21 new patients acquiring acute hepatitis B. 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. 35), 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. 36). 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. 37). 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. 31). 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. 38). 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

[[Page 11157]]

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. 39). 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 hepatitis B 
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 were 
not disinfected. Nurses did not routinely wash their hands or wear 
gloves when obtaining blood. Two of the five patients with acute 
nosocomial hepatitis B 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. 40). 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 1 patient. 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. 4). 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'' (1 patient), nursing 
and residential home (1 patient), ``private nursing and residential'' 
(1 patient) and ``local care home'' (2 patients). Eleven of the 21 
acutely infected patients had symptomatic HBV; seven of these patients 
died, five due to the HBV infection. All of the care sites in which 
acute HBV transmission occurred were using blood lancets designed 
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.

B. Benefits of the Device

    A blood lancet is used to puncture the skin to obtain small blood 
specimens for testing blood glucose, hemoglobin, and 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.
    Some blood lancets are also used with PT/INR anticoagulation 
meters. These devices are used in both home and professional health 
care settings. The PT and INR are used to monitor the effectiveness of 
the anticoagulant warfarin. Warfarin helps inhibit the formation of 
blood clots. The formation of blood clots may be associated with atrial 
fibrillation, the presence of artificial heart valves, deep venous 
thrombosis, and some cases of pulmonary embolism. Because the use of 
warfarin may cause excessive bleeding, patients are monitored, 
typically by PT/INR.
    Because newborns have relatively small amounts of blood compared to 
adults, it is usually preferred to use as small amount of blood as 
possible for any screening or other laboratory tests for newborns. 
Blood lancets may be used to perform heel sticks in newborns. Heel 
stick is a minimally invasive way of obtaining capillary blood samples. 
In newborns, heel sticks are the preferred collection method for small 
volumes of blood.
    The possible benefit of multiple use blood lancets for multiple 
patient use is that acute care hospitals may consider reusing a single 
device or using one device with multiple blades to have benefits, in 
that doing so may expedite procedures.

C. Risks to Health

    FDA has evaluated the risks to health associated with use of 
multiple use blood lancets for multiple patient use. In doing so, FDA 
considered information from the reports and recommendations of the 
General and Plastic Surgery Devices Panel of the Medical Devices 
Advisory Committee from the meeting of June 26, 2013, the adverse event 
reports for these devices in FDA's Manufacturer and User Facility 
Device Experience (MAUDE) database, and the published scientific 
literature, which is discussed in FDA's executive summary for the June 
26, 2013, panel. Based on this information, FDA has determined the 
following risks:
1. 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

[[Page 11158]]

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.
2. Sharp Object Injuries
    The blade of a 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.
3. 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 
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.
4. Adverse Tissue Reaction (Not Infection)
    Skin 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.

D. Summary of FDA Findings

    FDA believes multiple use blood lancets for multiple patient use 
should be reclassified from class I to class III. The Panel held on 
June 26, 2013, discussed and made recommendations regarding the 
regulatory classification of blood lancets to reclassify multiple use 
blood lancets for multiple patient use to class III under 513(e) of the 
FD&C Act. The Panel strongly agreed with FDA that based on the 
available scientific evidence, multiple use blood lancets for multiple 
patient use should be reclassified to class III because multiple use 
blood lancets for multiple patient use present a potential unreasonable 
risk of illness or injury. They also agreed that insufficient 
information exists to establish special controls for multiple use blood 
lancets for multiple patient use, because there is no evidence that 
these devices can be adequately cleaned and disinfected and that there 
is no proven method of doing so. Therefore, it is appropriate to 
regulate them in class III.
    FDA agrees with the Panel's recommendation that these devices 
present a potential unreasonable risk of illness or injury due to the 
inherent and significantly increased risk of bloodborne pathogen 
transmission risk as compared to single use only or single patient only 
blood lancets. FDA does not believe existing valid scientific evidence, 
as defined in Sec.  860.7 (21 CFR 860.7), supports a reasonable 
assurance that the device can be adequately reprocessed between uses on 
different patients. FDA also believes sufficient information does not 
exist to establish special controls for blood lancets intended for 
multiple patient use. Given the availability of safer single patient 
use blood lancet devices, FDA further believes that the probable 
benefits to health from use of the device do not outweigh the probable 
risks. Currently FDA is unaware of technology or other controls that 
would adequately mitigate against the inherent and significantly 
increased risk of blood borne pathogen transmission in multiple use 
blood lancets for use in multiple patients. Therefore, the safety and 
effectiveness of the multiple use blood lancets for multiple patients, 
particularly the effectiveness of their reprocessing instructions/
methods to render the device safe for use on more than one patient and 
the ability of health care providers to follow these instructions 
completely should be independently demonstrated for each device of this 
type via a PMA application. FDA is proposing to require an individual 
demonstration that a reasonable assurance of safety and effectiveness 
exists for each device within this type. The manufacturer of each 
individual device will have the opportunity to demonstrate the safety 
and effectiveness of the device for its intended use by submitting a 
PMA.

VI. PMA Requirements

    A PMA for this device must include the information required by 
section 515(c)(1) of the FD&C Act. Such a PMA should also include a 
detailed discussion of the risks identified previously in this 
document, as well as a discussion of the effectiveness of the device 
for which premarket approval is sought. In addition, a PMA must include 
all data and information on: (1) Any risks known, or that should be 
reasonably known, to the applicant that have not been identified in 
this document; (2) the effectiveness of the device that is the subject 
of the application; and (3) full reports of all preclinical and 
clinical information from investigations on the safety and 
effectiveness of the device for which premarket approval is sought.
    A PMA must include valid scientific evidence to demonstrate 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (Sec.  860.7(c)(2)). FDA defines valid scientific 
evidence in Sec.  860.7(c)(2)).
    To present reasonable assurance of safety and effectiveness of 
multiple use blood lancets for multiple patient use, FDA believes 
manufacturers should submit performance testing, including clinical 
trials of their device, in order to support PMA approval. Existing 
published clinical literature may also be leveraged as part of the PMA 
submission.

VII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA, FDA is required by section 
515(b)(2)(D) of the FD&C Act to provide an opportunity for interested 
persons to request a change in the classification of the device based 
on new information relevant to the classification. Any proceeding to 
reclassify the device will be under the authority of section 513(e) of 
the FD&C Act.
    A request for a change in the classification of this device is to 
be in the form of a reclassification petition containing the 
information required by 21 CFR 860.123, including new information 
relevant to the classification of the device.

VIII. 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.

IX. Paperwork Reduction Act of 1995

    This proposed order refers to collections of information that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 814, subparts B and E, have 
been approved under OMB control number 0910-0231. The collections of 
information in part 807, subpart E, have been approved under OMB 
control number 0910-0120. The collections of information under 21

[[Page 11159]]

CFR part 801 have been approved under OMB control number 0910-0485.

X. Proposed Effective Date

    FDA is proposing that any final order based on this proposal become 
effective on the date of its publication in the Federal Register or at 
a later date if stated in the final order.

XI. Codification of Orders

    Prior to the amendments by FDASIA, section 515(b) of the FD&C Act 
provided for FDA to issue regulations to require approval of an 
application for premarket approval for preamendments devices or devices 
found substantially equivalent to preamendments devices. Section 515(b) 
of the FD&C Act, as amended by FDASIA, provides for FDA to require 
approval of an application for premarket approval for such devices by 
issuing a final order, following the issuance of a proposed order in 
the Federal Register. FDA will continue to codify the requirement for 
an application for premarket approval, resulting from changes issued in 
a final order, in the Code of Federal Regulations (CFR). Therefore, 
under section 515(b)(1)(A) of the FD&C Act, as amended by FDASIA, in 
the proposed order, we are proposing to require approval of an 
application for premarket approval for multiple use blood lancets for 
multiple patient use and, if this proposed order is finalized, we will 
make the language in 21 CFR 878.4850(d) consistent with the final 
version of this proposed order.

XII. 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, available at 
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm349426.htm.
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Outbreaks in Care Homes in the UK Associated With Deficiencies in 
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Transmission in Ambulatory Health Care Settings'', Clinical 
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6. Schmid, R., ``History of Viral Hepatitis: A Tale of Dogmas and 
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2001; 16(7):718-722.
7. Graham, G., ``Diabetes Mellitus: A Survey of Changes in Treatment 
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8. Droller, H., ``An Outbreak of Hepatitis in a Diabetic Clinic'', 
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10. Farkas, K. and G. Jermendy, ``Transmission of Hepatitis B 
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(August 28, 1990), available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm241809.htm.
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Transmission of Hepatitis B Virus Associated With the Use of a 
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1992; 326(11):721-725.
15. 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.
16. Shier, N., J. Warren, M. Torabi, et al., ``Contamination of a 
Fingerstick Device'', New England Journal of Medicine, 1993; 
328:969-997.
17. Centers for Disease Control and Prevention (CDC), ``Increasing 
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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.)
18. Centers for Disease Control and Prevention (CDC), ``Incidence of 
Diagnosed Diabetes per 1,000 Population Aged 18-79 Years, by Age, 
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Use in Clinical Practice'', Sensors, 2010; 10(5):4558-4576.
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(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.)
23. 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. 
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States, 1998-2008'', Annals of Internal Medicine, 2009; 150: 33-39.
26. Khan, A.J., S.M. Cotter, B. Schulz, et al., ``Nosocomial 
Transmission of Hepatitis B Virus Infection Among Residents With 
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Hospital Epidemiology, 2002; 23:313-318.
27. Centers for Disease Control and Prevention (CDC), ``Transmission 
of

[[Page 11160]]

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.)
28. Thompson, N.D. and J.F. Perz, ``Eliminating the Blood: Ongoing 
Outbreaks of Hepatitis B Virus Infection and the Need for Innovative 
Glucose Monitoring Technologies'', Journal of Diabetes Science and 
Technology, 2009; 3(2):283-288.
29. 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.
30. Patel, A.S., M.B. White-Comstock, D. Woolard, et al., 
``Infection Control Practices in Assisted Living Facilities: A 
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31. Centers for Disease Control and Prevention (CDC), ``Multiple 
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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.)
32. Centers for Disease Control and Prevention (CDC), ``Notes From 
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Facility--North 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.)
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34. Thompson, N.D. and M.K. Schaefer, ```Never Events': Hepatitis B 
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Diabetes Science and Technology, 2011; 5(6):1396-1402.
35. 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.
36. Centers for Medical Services (CMS), ``Survey and Certification 
Memorandum'' (August 27, 2010) available at http://www.cms.gov/surveycertificationgeninfo/downloads/SCLetter10_28.pdf.
37. 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.)
38. Desenclos, J.C., M. Bourdiol-Razes, B. Rolin, et al., 
``Hepatitis C in a Ward for Cystic Fibrosis and Diabetic Patients: 
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Self-Monitoring of Capillary Blood Glucose'', Infection Control and 
Hospital Epidemiology, 2001; 22(11):701-707.
39. 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.
40. 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.

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, as proposed to be amended elsewhere in 
this issue of the Federal Register, be further 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. Add paragraph (d)(3) to Sec.  878.4850, under subpart E, to read as 
follows:

Sec.  878.4850  Blood Lancets.

* * * * *
    (d) * * *
    (3) Date PMA or notice of completion of a PDP is required: A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before [A DATE WILL BE ADDED 90 DAYS 
AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER CALLING FOR PMAs IN 
THE FEDERAL REGISTER OR 30 MONTHS AFTER DATE OF PUBLICATION OF A FUTURE 
FINAL ORDER RECLASSSIFYING INTO CLASS III, WHICHEVER IS LATER] for any 
multiple use blood lancet for multiple patient use described in 
paragraph (d)(1) of this section that was in commercial distribution 
before May 28, 1976, or that has, on or before [A DATE WILL BE ADDED 90 
DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER CALLING FOR PMAs 
IN THE FEDERAL REGISTER OR 30 MONTHS AFTER DATE OF PUBLICATION OF A 
FUTURE FINAL ORDER RECLASSSIFYING INTO CLASS III, WHICHEVER IS LATER], 
been found to be substantially equivalent to a multiple use blood 
lancet for multiple patient use described in paragraph (d)(1) of this 
section that was in commercial distribution before May 28, 1976. Any 
other multiple use blood lancet for multiple patient use shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

    Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04579 Filed 3-2-16; 8:45 am]
 BILLING CODE 4164-01-P