80 FR 33525 - Medical Devices; Exemption From Premarket Notification: Electric Positioning Chair

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 113 (June 12, 2015)

Page Range		33525-33526
FR Document		2015-14434

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).

Federal Register, Volume 80 Issue 113 (Friday, June 12, 2015)

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33525-33526]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14434]


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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, jismi.johnson@fda.hhs.gov.

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 dsmica@fda.hhs.gov 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

33526 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices

510(k) of the FD&C Act (21 U.S.C. GuidanceDocuments/UCM080199.pdf. male germ cell or from fetal exposure
360(k). Section 510(k) of the FD&C Act Send an email request to dsmica@ following seminal transfer of a
and the implementing regulations, 21 fda.hhs.gov to receive an electronic potentially developmental toxicant to
CFR part 807, require persons who copy of the document or send a fax pregnant females. The need for
intend to market a new device to submit request to 301–847–8149 to receive a measures to mitigate the risk to embryo/
a premarket notification (510(k)) hard copy. Please use the document fetal development posed by males
containing information that allows FDA number 159 to identify the guidance participating in clinical trials is also
to determine whether the new device is you are requesting. addressed.
‘‘substantially equivalent’’ within the DATES: Although you can comment on
III. Proposed Class II Device
meaning of section 513(i) of the FD&C any guidance at any time (see 21 CFR
Exemptions
Act to a legally marketed device that 10.115(g)(5)), to ensure that the Agency
does not require premarket approval. FDA has received the following
considers your comment on this draft
On November 21, 1997, the President petition requesting an exemption from
guidance before it begins work on the
signed into law FDAMA (Pub. L. 105– premarket notification for a class II
final version of the guidance, submit
115). Section 206 of FDAMA, in part, device: Brian Orwat, Stryker Medical,
either electronic or written comments
added a new section, 510(m), to the 3800 East Centre Ave., Portage, MI
on the draft guidance by August 11,
FD&C Act. Section 510(m)(1) of the 49002 for its electric positioning chair
2015.
FD&C Act requires FDA, within 60 days classified under 21 CFR 890.3110.
after enactment of FDAMA, to publish ADDRESSES: Submit written requests for
IV. Comments single copies of the draft guidance to the
in the Federal Register a list of each
type of class II device that does not Interested persons may submit either Division of Drug Information, Center for
require a report under section 510(k) of electronic comments regarding this Drug Evaluation and Research, Food
the FD&C Act to provide reasonable document to http://www.regulations.gov and Drug Administration, 10001 New
assurance of safety and effectiveness. or written comments to the Division of Hampshire Ave., Hillandale Building,
Section 510(m) of the FD&C Act further Dockets Management (see ADDRESSES). It 4th Floor, Silver Spring, MD 20993–
provides that a 510(k) will no longer be is only necessary to send one set of 0002. Send one self-addressed adhesive
required for these devices upon the date comments. Identify comments with the label to assist that office in processing
of publication of the list in the Federal docket number found in brackets in the your requests. See the SUPPLEMENTARY
Register. FDA published that list in the heading of this document. Received INFORMATION section for electronic
Federal Register of January 21, 1998 (63 comments may be seen in the Division access to the draft guidance document.
FR 3142). of Dockets Management between 9 a.m. Submit electronic comments on the
Section 510(m)(2) of the FD&C Act and 4 p.m., Monday through Friday, and draft guidance to http://
provides that 1 day after date of will be posted to the docket at http:// www.regulations.gov. Submit written
publication of the list under section www.regulations.gov. comments to the Division of Dockets
510(m)(1), FDA may exempt a device on Management (HFA–305), Food and Drug
Dated: June 9, 2015.
its own initiative or upon petition of an Administration, 5630 Fishers Lane, Rm.
Leslie Kux, 1061, Rockville, MD 20852.
interested person if FDA determines Associate Commissioner for Policy.
that a 510(k) is not necessary to provide FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–14434 Filed 6–11–15; 8:45 am] Lynnda Reid, Center for Drug
reasonable assurance of the safety and
effectiveness of the device. This section BILLING CODE 4164–01–P Evaluation and Research, Food and
requires FDA to publish in the Federal Drug Administration, 10903 New
Register a notice of intent to exempt a Hampshire Ave., Bldg. 22, Rm. 5388,
DEPARTMENT OF HEALTH AND Silver Spring, MD 20993–0002, 301–
device, or of the petition, and to provide
HUMAN SERVICES 796–0984.
a 30-day comment period. Within 120
days of publication of this document, Food and Drug Administration SUPPLEMENTARY INFORMATION:
FDA must publish in the Federal
[Docket No. FDA–2015–D–2001] I. Background
Register its final determination
regarding the exemption of the device FDA is announcing the availability of
Assessment of Male-Mediated a draft guidance for industry entitled
that was the subject of the notice. If FDA
Developmental Risk for ‘‘Assessment of Male-Mediated
fails to respond to a petition under this
Pharmaceuticals; Draft Guidance for Developmental Risk for
section within 180 days of receiving it,
Industry; Availability Pharmaceuticals.’’ This guidance
the petition shall be deemed granted.
AGENCY: Food and Drug Administration, presents an overview of FDA’s current
II. Criteria for Exemption approach to assessing potential risks
HHS.
There are a number of factors FDA ACTION: Notice. associated with pharmaceutical use in
may consider to determine whether a male patients. Current regulatory
510(k) is necessary to provide SUMMARY: The Food and Drug guidance exists regarding the need to
reasonable assurance of the safety and Administration (FDA or Agency) is assess the genotoxic and embryo/fetal
effectiveness of a class II device. These announcing the availability of a draft developmental toxicity potential of
factors are discussed in the guidance the guidance for industry entitled pharmaceuticals before their
Agency issued on February 19, 1998, ‘‘Assessment of Male-Mediated administration to pregnant women and
mstockstill on DSK4VPTVN1PROD with NOTICES

entitled ‘‘Procedures for Class II Device Developmental Risk for females of reproductive potential.
Exemptions from Premarket Pharmaceuticals.’’ This draft guidance However, there is a lack of consistency
Notification, Guidance for Industry and provides recommendations to sponsors in clinical trial protocol designs and
CDRH Staff.’’ That guidance is available for assessing risks to embryo/fetal labeling documents regarding pregnancy
through the Internet at http:// development resulting from risk for sexual partners of men being
www.fda.gov/downloads/ administration of an active administered an API. The conceptus of
MedicalDevices/ pharmaceutical ingredient (API) to a female sexual partner may be subject
DeviceRegulationandGuidance/ males either through an effect on the to developmental risk associated with

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Document Created: 2018-02-22 10:15:56
Document Modified: 2018-02-22 10:15:56

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.
Dates		Submit either electronic or written comments by July 13, 2015.
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]
FR Citation		80 FR 33525

80 FR 33525 - Medical Devices; Exemption From Premarket Notification: Electric Positioning Chair

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 113 (June 12, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration