[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34763-34764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14215]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-P-0231]
Medical Devices; Exemption From Premarket Notification:
Wheelchair Elevator
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
has received a petition requesting exemption from the premarket
notification requirements for a wheelchair elevator device commonly
known as a manually operated portable wheelchair lift. This device is
used to provide a means for a disabled person to move a wheelchair from
one level to another. FDA is publishing this notice to obtain comments
in accordance with procedures established by the Food and Drug
Administration Modernization Act of 1997 (FDAMA).
DATES: Submit either electronic or written comments by July 18, 2014.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
P-0231, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-P-0231 for this notice. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
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: Michael J. Ryan, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-
796-6283, [email protected].
SUPPLEMENTARY INFORMATION:
I. Statutory Background
Under section 513 of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three
regulatory classes: Class I, class II, or class III. FDA classification
of a device is determined by the amount of regulation necessary to
provide a reasonable assurance of safety and effectiveness. Under the
Medical Device Amendments of 1976 (1976 amendments) (Public Law 94-
295), as amended by the Safe Medical Devices Act of 1990 (Public Law
101-629), devices are to be classified into class I (general controls)
if there is information showing that the general controls of the FD&C
Act are sufficient to assure safety and effectiveness; into class II
(special controls) if general controls, by themselves, are insufficient
to provide reasonable assurance of safety and effectiveness, but there
is sufficient information to establish special controls to provide such
assurance; and into class III (premarket approval) if there is
insufficient information to support classifying a device into class I
or class II and the device is a life sustaining or life supporting
device, or is for a use which is of substantial importance in
preventing impairment of human health or presents a potential
unreasonable risk of illness or injury.
Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the FD&C Act through the
issuance of classification regulations into one of these three
regulatory classes. Devices introduced into interstate commerce for the
first time on or after May 28, 1976 (generally referred to as
postamendments devices), are classified through the premarket
notification process under section 510(k) of the FD&C Act (21 U.S.C.
360(k). Section 510(k) of the FD&C Act and the implementing
regulations, 21 CFR part 807, require persons who intend to market a
new device to submit 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.
On November 21, 1997, the President signed into law FDAMA (Public
Law 105-115). Section 206 of FDAMA, in part, added a new section,
510(m), to the FD&C Act. Section 510(m)(1) of the FD&C Act requires
FDA, within 60 days after enactment of FDAMA, to publish in the Federal
Register a list of each type of class II device that does not require a
report under section 510(k) of the FD&C Act to provide reasonable
assurance of safety and effectiveness. Section 510(m) of the FD&C Act
further provides that a 510(k) will no longer be required for these
devices upon the date of publication of the list in the Federal
Register. FDA published that list in the Federal Register of January
21, 1998 (63 FR 3142).
Section 510(m)(2) of the FD&C Act provides that 1 day after date of
publication of the list under section 510(m)(1), FDA may exempt a
device on its own initiative or upon petition of an interested person
if FDA determines that a 510(k) is not necessary to provide reasonable
assurance of the safety and
[[Page 34764]]
effectiveness of the device. This section requires FDA to publish in
the Federal Register a notice of intent to exempt a device, or of the
petition, and to provide a 30-day comment period. Within 120 days of
publication of this document, FDA must publish in the Federal Register
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
this section within 180 days of receiving it, the petition shall be
deemed granted.
II. Criteria 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
guidance the Agency issued on February 19, 1998, entitled ``Procedures
for Class II Device Exemptions from Premarket Notification, Guidance
for Industry and CDRH Staff.'' That guidance is available through the
Internet at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf. Send an
email request to [email protected] to receive an electronic copy of
the document or send a fax request to 301-847-8149 to receive a hard
copy. Please use the document number 159 to identify the guidance you
are requesting.
III. Proposed Class II Device Exemptions
FDA has received the following petition requesting an exemption
from premarket notification for a class II device: Dave Smith, on
behalf of Adaptive Engineering, Inc., for its wheelchair elevator
device (commonly known as a manually operated portable wheelchair
lift), classified under 21 CFR 890.3930.
IV. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Dated: June 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14215 Filed 6-17-14; 8:45 am]
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