Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device; Correction, 47373 [2017-21982]
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Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Rules and Regulations
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for that affected control surface, unless the
FAA-approved repair instructions specify
otherwise.
(6) Replacement of the affected part on an
airplane with a part listed in table 1 of PAI
SB No. 80–0455, constitutes terminating
action for the repetitive inspections required
by this AD for that part.
(7) You may incorporate the actions of PAI
SB No. 80–0455, into your FAA-approved
airplane inspection program (AIP) or
maintenance program (instructions for
continued airworthiness) to ensure the
continuing airworthiness of each operated
airplane.
(8) After November 16, 2017 (the effective
date of this AD), you may install on an
airplane an affected control surface not listed
in table 1 of PAI SB No. 80–0455, provided
that before further flight after installation, the
affected control surface has been inspected as
specified in this AD and found airworthy.
(g) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, Standards Office,
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. Send information to
ATTN: Mike Kiesov, Aerospace Engineer,
FAA, Small Airplane Standards Branch, 901
Locust, Room 301, Kansas City, Missouri
64106; telephone: (816) 329–4144; fax: (816)
329–4090; email: mike.kiesov@faa.gov.
Before using any approved AMOC on any
airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in
the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective
actions from a manufacturer, the action must
be accomplished using a method approved
by the Manager, Small Airplane Standards
Branch, FAA; or the European Aviation
Safety Agency (EASA).
(3) Reporting Requirements: For any
reporting requirement in this AD, a federal
agency may not conduct or sponsor, and a
person is not required to respond to, nor
shall a person be subject to a penalty for
failure to comply with a collection of
information subject to the requirements of
the Paperwork Reduction Act unless that
collection of information displays a current
valid OMB Control Number. The OMB
Control Number for this information
collection is 2120–0056. Public reporting for
this collection of information is estimated to
be approximately 5 minutes per response,
including the time for reviewing instructions,
completing and reviewing the collection of
information. All responses to this collection
of information are mandatory. Comments
concerning the accuracy of this burden and
suggestions for reducing the burden should
be directed to the FAA at: 800 Independence
Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer,
AES–200.
(h) Related Information
Refer to MCAI European Aviation Safety
Agency (EASA) AD No.: 2017–0045, dated
VerDate Sep<11>2014
14:21 Oct 11, 2017
Jkt 244001
March 9, 2017 for related information. You
may examine the MCAI on the Internet at
https://www.regulations.gov/
document?D=FAA-2017-0648-0002.
(i) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless this AD specifies otherwise.
(i) PIAGGIO AERO INDUSTRIES S.p.A.
Mandatory Service Bulletin (SB) No.: 80–
0455, dated January 13, 2017.
(ii) Reserved.
(3) For PIAGGIO AERO INDUSTRIES
S.p.A. service information identified in this
AD, contact PIAGGIO AERO INDUSTRIES
S.p.A.—Continued Airworthiness, Via
Pionieri e Aviatori d’Italia snc—16154
Genova, Italy; Telephone: +39 010 0998046;
Fax: None; email: airworthiness@
piaggioaerospace.it; Internet:
www.piaggioaerospace.it/en/customersupport#care.
(4) You may view this service information
at the FAA, Policy and Innovation Division,
901 Locust, Kansas City, Missouri 64106. For
information on the availability of this
material at the FAA, call (816) 329–4148. In
addition, you can access this service
information on the Internet at https://
www.regulations.gov by searching for and
locating Docket No. FAA–2017–0648.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Kansas City, Missouri, on
September 29, 2017.
Pat Mullen,
Acting Deputy Director, Policy & Innovation
Division, Aircraft Certification Service.
[FR Doc. 2017–21443 Filed 10–11–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA–2017–N–1608]
Medical Devices; Neurological
Devices; Classification of Cranial
Motion Measurement Device;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order; correction.
final order entitled ‘‘Medical Devices;
Neurological Devices; Classification of
Cranial Motion Measurement Device’’
that appeared in the Federal Register of
July 28, 2017. The final order was
published with an incorrect statement
in the preamble about whether FDA
planned to exempt the device from
premarket notification requirements.
This document corrects that error.
DATES:
Effective October 12, 2017.
Jay
Gupta, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2611, Silver Spring,
MD 20993–0002, 301–796–2795,
jay.gupta@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In the
Federal Register of July 28, 2017 (82 FR
35069), FDA published the final order
‘‘Medical Devices; Neurological Devices;
Classification of Cranial Motion
Measurement Device.’’ The final order
published with an incorrect statement
in the preamble about whether FDA
planned to exempt the device from
premarket notification requirements
under section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360(k)).
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of July 28,
2017, in FR Doc. 2017–15895, the
following correction is made:
On page 35070, after table 1 in the third
column, the last paragraph is corrected to
read as follows:
‘‘Section 510(m) of the FD&C Act provides
that FDA may exempt a class II device from
the premarket notification requirements
under section 510(k), if FDA determines that
premarket notification is not necessary to
provide reasonable assurance of the safety
and effectiveness of the device. For this type
of device, FDA has determined that
premarket notification is necessary to
provide reasonable assurance of the safety
and effectiveness of the device. Therefore,
this device type is not exempt from
premarket notification requirements. Persons
who intend to market this type of device
must submit to FDA a premarket notification,
prior to marketing the device, which contains
information about the cranial motion
measurement device they intend to market.’’
Dated: October 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–21982 Filed 10–11–17; 8:45 am]
BILLING CODE 4164–01–P
The Food and Drug
Administration (FDA) is correcting a
SUMMARY:
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[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Rules and Regulations]
[Page 47373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21982]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-2017-N-1608]
Medical Devices; Neurological Devices; Classification of Cranial
Motion Measurement Device; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a final
order entitled ``Medical Devices; Neurological Devices; Classification
of Cranial Motion Measurement Device'' that appeared in the Federal
Register of July 28, 2017. The final order was published with an
incorrect statement in the preamble about whether FDA planned to exempt
the device from premarket notification requirements. This document
corrects that error.
DATES: Effective October 12, 2017.
FOR FURTHER INFORMATION CONTACT: Jay Gupta, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2611, Silver Spring, MD 20993-0002, 301-796-2795,
jay.gupta@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 28, 2017 (82
FR 35069), FDA published the final order ``Medical Devices;
Neurological Devices; Classification of Cranial Motion Measurement
Device.'' The final order published with an incorrect statement in the
preamble about whether FDA planned to exempt the device from premarket
notification requirements under section 510(k) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)).
Correction
In the Federal Register of July 28, 2017, in FR Doc. 2017-15895,
the following correction is made:
On page 35070, after table 1 in the third column, the last
paragraph is corrected to read as follows:
``Section 510(m) of the FD&C Act provides that FDA may exempt a
class II device from the premarket notification requirements under
section 510(k), if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket
notification requirements. Persons who intend to market this type of
device must submit to FDA a premarket notification, prior to
marketing the device, which contains information about the cranial
motion measurement device they intend to market.''
Dated: October 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21982 Filed 10-11-17; 8:45 am]
BILLING CODE 4164-01-P
