[Federal Register Volume 77, Number 106 (Friday, June 1, 2012)]
[Notices]
[Pages 32644-32645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13224]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0882]
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 wheelchair elevator devices commonly
known as inclined platform lifts and vertical platform lifts. These
devices are 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 2, 2012.
ADDRESSES: You may submit comments, identified with the FDA docket
number found in brackets in the heading of this document, 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 ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
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 number 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: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527,
FAX: 301-847-8122.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
Under section 513 of the Federal Food, Drug, and Cosmetic Act (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) (Pub. L. 94-295)),
as amended by the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 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 (Pub. L.
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 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.
[[Page 32645]]
gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/UCM080199.pdf or by sending 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: Richard Keller, on
behalf of Bruno Independent Living Aids, Inc., for wheelchair elevator
devices (commonly known as inclined platform lifts and vertical
platform lifts), classified under 21 CFR 890.3930.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. 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: May 25, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-13224 Filed 5-31-12; 8:45 am]
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