82 FR 51633 - Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 214 (November 7, 2017)

Page Range		51633-51635
FR Document		2017-24163
The Food and Drug Administration (FDA or the Agency) is announcing its intent to exempt a list of class II devices from premarket notification requirements, subject to certain limitations. The Agency has determined that, based on established factors, these devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. FDA is publishing this notice to obtain comments regarding the proposed exemptions, in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Federal Register, Volume 82 Issue 214 (Tuesday, November 7, 2017)
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51633-51635]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24163]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1129]


Medical Devices; Exemptions From Premarket Notification: Class II 
Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing its intent to exempt a list of class II devices from 
premarket notification requirements, subject to certain limitations. 
The Agency has determined that, based on established factors, these 
devices no longer require premarket notification to provide reasonable 
assurance of safety and effectiveness. FDA is publishing this notice to 
obtain comments regarding the proposed exemptions, in accordance with 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments on the notice by 
January 8, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 8, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 8, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-1129 for ``Medical Devices; Exemptions from Premarket 
Notification: Class II Devices; Request for Comments.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, 
[email protected].

SUPPLEMENTARY INFORMATION :

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the 
implementing regulations, 21 CFR part 807 subpart E, require persons 
who intend to market a new device to submit and obtain clearance of a 
premarket notification (510(k)) containing information that allows FDA 
to determine whether the new device is ``substantially equivalent'' 
within the meaning of section 513(i) of the FD&C Act to a legally 
marketed device that does not require premarket approval.
    The 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed 
into law on December 13, 2016. Section 3054 of the Cures Act amended 
section 510(m) of the FD&C Act. As amended,

[[Page 51634]]

section 510(m)(1)(A) of the FD&C Act requires FDA to publish in the 
Federal Register a notice containing a list of each type of class II 
device that FDA determines no longer requires a report under section 
510(k) of the FD&C Act to provide reasonable assurance of safety and 
effectiveness. FDA is required to publish this notice within 90 days of 
the date of enactment of the Cures Act and at least once every 5 years 
thereafter, as FDA determines appropriate. Additionally, FDA must 
provide at least a 60-day comment period for any such notice required 
to be published under section 510(m)(1)(A) of the FD&C Act. FDA 
published this notice in the Federal Register of March 14, 2017 (82 FR 
13609). Under section 510(m)(1)(B) of the FD&C Act, FDA must publish in 
the Federal Register, within 210 days of enactment of the Cures Act, a 
list representing its final determination regarding the exemption of 
the devices that were contained in the list published under section 
510(m)(1)(A). FDA published that list in the Federal Register of July 
11, 2017 (82 FR 31976).
    As amended, section 510(m)(2) of the FD&C Act provides that, 1 day 
after the date of publication of the final list under section 
510(m)(1), FDA may exempt a class II device from the requirement to 
submit a report under section 510(k) of the FD&C Act upon its own 
initiative or a petition of an interested person, if FDA determines 
that a report under section 510(k) is not necessary to assure the 
safety and effectiveness of the device. To do so, FDA must publish in 
the Federal Register a notice of its intent to exempt the device, or of 
the petition, and provide a 60-day period for public comment. Within 
120 days after the issuance of this notice, FDA must publish an order 
in the Federal Register that sets forth its final determination 
regarding the exemption of the device that was the subject of the 
notice. If FDA fails to respond to a petition under section 510(m)(2) 
of the FD&C Act within 180 days of receiving it, the petition shall be 
deemed granted.

II. Factors FDA May Consider for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a class II device. These factors are discussed in the 
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently 
in the guidance the Agency issued on February 19, 1998, entitled 
``Procedures for Class II Device Exemptions from Premarket 
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k) 
Exemption Guidance'') (Ref. 1). Accordingly, FDA generally considers 
the following factors to determine whether premarket notification is 
necessary for class II devices: (1) The device does not have a 
significant history of false or misleading claims or of risks 
associated with inherent characteristics of the device; (2) 
characteristics of the device necessary for its safe and effective 
performance are well established; (3) changes in the device that could 
affect safety and effectiveness will either (a) be readily detectable 
by users by visual examination or other means such as routine testing, 
before causing harm, or (b) not materially increase the risk of injury, 
incorrect diagnosis, or ineffective treatment; and (4) any changes to 
the device would not be likely to result in a change in the device's 
classification. FDA may also consider that, even when exempting 
devices, these devices would still be subject to the limitations on 
exemptions.

III. Limitations on Exemptions

    FDA has determined that premarket notification is not necessary to 
assure the safety and effectiveness of the class II devices listed in 
table 1. This determination is based, in part, on the Agency's 
knowledge of the device, including past experience and relevant reports 
or studies on device performance (as appropriate), the applicability of 
general and special controls, and the Agency's ability to limit an 
exemption.

A. General Limitations of Exemptions

    FDA's proposal to grant an exemption from premarket notification 
for class II devices listed in table 1 applies only to those devices 
that have existing or reasonably foreseeable characteristics of 
commercially distributed devices within that generic type, or, in the 
case of in vitro diagnostic devices, for which a misdiagnosis, as a 
result of using the device, would not be associated with high morbidity 
or mortality. FDA proposes that a manufacturer of a listed device would 
still be required to submit a premarket notification to FDA before 
introducing a device or delivering it for introduction into commercial 
distribution when the device meets any of the conditions described in 
21 CFR 862.9 to 21 CFR 892.9.

B. Partial Limitations of Exemptions

    In addition to the general limitations, FDA may also partially 
limit an exemption from premarket notification requirements to specific 
devices within a listed device type when initial Agency assessment 
determines that the factors laid out in the Class II 510(k) Exemption 
Guidance (Ref. 1) do not weigh in favor of exemption for all devices in 
a particular group. In such situations where a partial exemption 
limitation has been identified, FDA has determined that premarket 
notification is necessary to provide a reasonable assurance of safety 
and effectiveness for these devices. In table 1, for example, FDA is 
listing the proposed exemption of the genetic health risk assessment 
system, but limits the exemption to such devices that have received a 
first-time FDA marketing authorization (e.g., 510(k) clearance) for the 
genetic health risk assessment system (a ``one-time FDA reviewed 
genetic health risk assessment system''). FDA believes that a one-time 
FDA review (e.g., premarket notification) of a genetic health risk 
assessment system is necessary to provide reasonable assurance of the 
safety and effectiveness of the device. FDA believes that a one-time 
FDA review of a genetic health risk assessment system is necessary to 
mitigate the risk of false negatives and false positives by ensuring 
that certain information be submitted to FDA to allow the Agency to 
assess the safety and effectiveness of the devices and the regulatory 
controls necessary to address those issues as well as to ensure the 
devices perform to acceptable standards.

IV. List of Class II Devices

    FDA is identifying the following list of class II devices that, if 
finalized, would no longer require premarket notification under section 
510(k) of the FD&C Act, subject to the general limitations to the 
exemptions found in Sec. Sec.  862.9 to 892.9:

                                            Table 1--Class II Devices
----------------------------------------------------------------------------------------------------------------
                                                                                    Partial exemption limitation
         21 CFR section                    Device type             Product code            (if applicable)
----------------------------------------------------------------------------------------------------------------
862.1840........................  Total 25-hydroxyvitamin D     PSL
                                   Mass Spectrometry Test
                                   System.

[[Page 51635]]

 
866.5950........................  Genetic Health Risk           PTA                 Exemption is limited to a
                                   Assessment System.                                genetic health risk
                                                                                     assessment system that has
                                                                                     received a first-time FDA
                                                                                     marketing authorization
                                                                                     (e.g., 510(k) clearance)
                                                                                     for the genetic health risk
                                                                                     assessment system (a ``one-
                                                                                     time FDA reviewed genetic
                                                                                     health risk assessment
                                                                                     system'').
876.1500........................  Endoscopic Maintenance        PUP
                                   System.
880.6710........................  Purifier, Water,              KMG
                                   Ultraviolet, Medical.
884.5960........................  Vibrator for Therapeutic      KXQ
                                   Use, Genital.
----------------------------------------------------------------------------------------------------------------

V. Reference

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

1. FDA Guidance, ``Procedures for Class II Device Exemptions from 
Premarket Notification, Guidance for Industry and CDRH Staff,'' 
February 19, 1998, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.

    Dated: October 31, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24163 Filed 11-6-17; 8:45 am]
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51634 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices

section 510(m)(1)(A) of the FD&C Act factors are discussed in the January 21, proposes that a manufacturer of a listed
requires FDA to publish in the Federal 1998, Federal Register notice (63 FR device would still be required to submit
Register a notice containing a list of 3142) and subsequently in the guidance a premarket notification to FDA before
each type of class II device that FDA the Agency issued on February 19, 1998, introducing a device or delivering it for
determines no longer requires a report entitled ‘‘Procedures for Class II Device introduction into commercial
under section 510(k) of the FD&C Act to Exemptions from Premarket distribution when the device meets any
provide reasonable assurance of safety Notification, Guidance for Industry and of the conditions described in 21 CFR
and effectiveness. FDA is required to CDRH Staff’’ (‘‘Class II 510(k) 862.9 to 21 CFR 892.9.
publish this notice within 90 days of the Exemption Guidance’’) (Ref. 1).
date of enactment of the Cures Act and Accordingly, FDA generally considers B. Partial Limitations of Exemptions
at least once every 5 years thereafter, as the following factors to determine In addition to the general limitations,
FDA determines appropriate. whether premarket notification is FDA may also partially limit an
Additionally, FDA must provide at least necessary for class II devices: (1) The exemption from premarket notification
a 60-day comment period for any such device does not have a significant requirements to specific devices within
notice required to be published under history of false or misleading claims or a listed device type when initial Agency
section 510(m)(1)(A) of the FD&C Act. of risks associated with inherent assessment determines that the factors
FDA published this notice in the characteristics of the device; (2) laid out in the Class II 510(k) Exemption
Federal Register of March 14, 2017 (82 characteristics of the device necessary Guidance (Ref. 1) do not weigh in favor
FR 13609). Under section 510(m)(1)(B) for its safe and effective performance are of exemption for all devices in a
of the FD&C Act, FDA must publish in well established; (3) changes in the particular group. In such situations
the Federal Register, within 210 days of device that could affect safety and where a partial exemption limitation
enactment of the Cures Act, a list effectiveness will either (a) be readily has been identified, FDA has
representing its final determination detectable by users by visual determined that premarket notification
regarding the exemption of the devices examination or other means such as is necessary to provide a reasonable
that were contained in the list published routine testing, before causing harm, or assurance of safety and effectiveness for
under section 510(m)(1)(A). FDA (b) not materially increase the risk of these devices. In table 1, for example,
published that list in the Federal injury, incorrect diagnosis, or ineffective FDA is listing the proposed exemption
Register of July 11, 2017 (82 FR 31976). treatment; and (4) any changes to the of the genetic health risk assessment
As amended, section 510(m)(2) of the device would not be likely to result in system, but limits the exemption to such
FD&C Act provides that, 1 day after the a change in the device’s classification. devices that have received a first-time
date of publication of the final list under FDA may also consider that, even when FDA marketing authorization (e.g.,
section 510(m)(1), FDA may exempt a exempting devices, these devices would 510(k) clearance) for the genetic health
class II device from the requirement to still be subject to the limitations on risk assessment system (a ‘‘one-time
submit a report under section 510(k) of exemptions. FDA reviewed genetic health risk
the FD&C Act upon its own initiative or
III. Limitations on Exemptions assessment system’’). FDA believes that
a petition of an interested person, if
a one-time FDA review (e.g., premarket
FDA determines that a report under FDA has determined that premarket
notification) of a genetic health risk
section 510(k) is not necessary to assure notification is not necessary to assure
assessment system is necessary to
the safety and effectiveness of the the safety and effectiveness of the class
provide reasonable assurance of the
device. To do so, FDA must publish in II devices listed in table 1. This
safety and effectiveness of the device.
the Federal Register a notice of its determination is based, in part, on the
FDA believes that a one-time FDA
intent to exempt the device, or of the Agency’s knowledge of the device,
review of a genetic health risk
petition, and provide a 60-day period including past experience and relevant
assessment system is necessary to
for public comment. Within 120 days reports or studies on device
mitigate the risk of false negatives and
after the issuance of this notice, FDA performance (as appropriate), the
false positives by ensuring that certain
must publish an order in the Federal applicability of general and special
information be submitted to FDA to
Register that sets forth its final controls, and the Agency’s ability to
allow the Agency to assess the safety
determination regarding the exemption limit an exemption.
and effectiveness of the devices and the
of the device that was the subject of the
A. General Limitations of Exemptions regulatory controls necessary to address
notice. If FDA fails to respond to a
FDA’s proposal to grant an exemption those issues as well as to ensure the
petition under section 510(m)(2) of the
from premarket notification for class II devices perform to acceptable standards.
FD&C Act within 180 days of receiving
it, the petition shall be deemed granted. devices listed in table 1 applies only to IV. List of Class II Devices
those devices that have existing or
II. Factors FDA May Consider for reasonably foreseeable characteristics of FDA is identifying the following list
Exemption commercially distributed devices within of class II devices that, if finalized,
There are a number of factors FDA that generic type, or, in the case of in would no longer require premarket
may consider to determine whether a vitro diagnostic devices, for which a notification under section 510(k) of the
510(k) is necessary to provide misdiagnosis, as a result of using the FD&C Act, subject to the general
reasonable assurance of the safety and device, would not be associated with limitations to the exemptions found in
effectiveness of a class II device. These high morbidity or mortality. FDA §§ 862.9 to 892.9:
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TABLE 1—CLASS II DEVICES
Product Partial exemption limitation
21 CFR section Device type code (if applicable)

862.1840 ............... Total 25-hydroxyvitamin D Mass Spectrometry Test PSL
System.

VerDate Sep<11>2014 17:29 Nov 06, 2017 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1
Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51635

TABLE 1—CLASS II DEVICES—Continued
Product Partial exemption limitation
21 CFR section Device type code (if applicable)

866.5950 ............... Genetic Health Risk Assessment System .................... PTA Exemption is limited to a genetic health risk assess-
ment system that has received a first-time FDA mar-
keting authorization (e.g., 510(k) clearance) for the
genetic health risk assessment system (a ‘‘one-time
FDA reviewed genetic health risk assessment sys-
tem’’).
876.1500 ............... Endoscopic Maintenance System ................................. PUP
880.6710 ............... Purifier, Water, Ultraviolet, Medical ............................... KMG
884.5960 ............... Vibrator for Therapeutic Use, Genital ........................... KXQ

V. Reference DEPARTMENT OF HEALTH AND Flint North, 10A–12M, 11601
The following reference is on display HUMAN SERVICES Landsdown St., North Bethesda, MD
in the Dockets Management Staff (see 20852, 301–796–7726, PRAStaff@
ADDRESSES) and is available for viewing
Food and Drug Administration fda.hhs.gov.
by interested persons between 9 a.m. [Docket Nos. FDA–2013–N–0618; FDA–
and 4 p.m., Monday through Friday; it 2013–N–1155; FDA–2010–N–0118; FDA– SUPPLEMENTARY INFORMATION: The
is also available electronically at https:// 2011–N–0655; FDA–2014–N–0086; FDA– following is a list of FDA information
www.regulations.gov. FDA has verified 2011–N–0144; FDA–2016–N–2836] collections recently approved by OMB
the Web site address, as of the date this under section 3507 of the Paperwork
document publishes in the Federal Agency Information Collection Reduction Act of 1995 (44 U.S.C. 3507).
Register, but Web sites are subject to Activities; Announcement of Office of The OMB control number and
change over time. Management and Budget Approvals expiration date of OMB approval for
1. FDA Guidance, ‘‘Procedures for Class II AGENCY: Food and Drug Administration, each information collection are shown
Device Exemptions from Premarket HHS. in table 1. Copies of the supporting
Notification, Guidance for Industry and ACTION: Notice. statements for the information
CDRH Staff,’’ February 19, 1998, collections are available on the internet
available at https://www.fda.gov/ SUMMARY: The Food and Drug at https://www.reginfo.gov/public/do/
downloads/MedicalDevices/ Administration (FDA) is publishing a PRAMain. An Agency may not conduct
DeviceRegulationandGuidance/ list of information collections that have
GuidanceDocuments/UCM080199.pdf. or sponsor, and a person is not required
been approved by the Office of to respond to, a collection of
Dated: October 31, 2017. Management and Budget (OMB) under information unless it displays a
Lauren Silvis, the Paperwork Reduction Act of 1995. currently valid OMB control number.
Chief of Staff. FOR FURTHER INFORMATION CONTACT: Ila
[FR Doc. 2017–24163 Filed 11–6–17; 8:45 am] S. Mizrachi, Office of Operations, Food
BILLING CODE 4164–01–P and Drug Administration, Three White

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control Date approval
Title of collection No. expires

Reporting and Recordkeeping for Electronic Products—General Requirements ................................................... 0910–0025 7/31/2020
Food Labeling Regulations ...................................................................................................................................... 0910–0381 7/31/2020
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 ........................................................................................................................................................... 0910–0520 7/31/2020
Animal Generic Drug User Fee Act Cover Sheet ................................................................................................... 0910–0632 7/31/2020
Potential Tobacco Product Violations Reporting Form ........................................................................................... 0910–0716 7/31/2020
Voluntary Qualified Importer Program Guidance for Industry ................................................................................. 0910–0840 7/31/2020
Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute—Sponsored
Transfusion-Transmissible Infectious Monitoring System ................................................................................... 0910–0841 7/31/2020

Dated: November 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24189 Filed 11–6–17; 8:45 am]
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BILLING CODE 4164–01–P

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Document Created: 2018-10-25 10:26:37
Document Modified: 2018-10-25 10:26:37
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; request for comments.
Dates		Submit either electronic or written comments on the notice by January 8, 2018.
Contact		Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, [email protected]
FR Citation		82 FR 51633
82 FR 51633 - Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 214 (November 7, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
