[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33525-33526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14434]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-P-1197]


Medical Devices; Exemption From Premarket Notification: Electric 
Positioning Chair

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
has received a petition requesting exemption from the premarket 
notification requirements for an electric positioning chair with a 
motorized positioning control that is intended for medical purposes and 
that can be adjusted to various positions. The device is used to 
provide stability for patients with athetosis (involuntary spasms) and 
to alter postural positions. 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 13, 2015.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2015-
P-1197, 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 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: Jismi Johnson, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-
796-6424, [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) (Pub. L. 94-295), 
as amended by the Safe Medical Devices Act of 1990 (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

[[Page 33526]]

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.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: Brian Orwat, Stryker 
Medical, 3800 East Centre Ave., Portage, MI 49002 for its electric 
positioning chair classified under 21 CFR 890.3110.

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, and will be posted to the docket at http://www.regulations.gov.

    Dated: June 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14434 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P