[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]
BILLING CODE 4160-01-P